Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 27, 2024 | Jun. 30, 2023 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Interactive Data Current | Yes | ||
ICFR Auditor Attestation Flag | false | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Documents Incorporated by Reference [Text Block] | Certain information in Part III of this Annual Report on Form 10-K is incorporated by reference to our definitive Proxy Statement for the 2024 Annual Meeting of Shareholders to be filed with the Securities and Exchange Commission within 120 days after the fiscal year ended December 31, 2023. | ||
Entity Information [Line Items] | |||
Entity Registrant Name | INMUNE BIO INC. | ||
Entity Central Index Key | 0001711754 | ||
Entity File Number | 001-38793 | ||
Entity Tax Identification Number | 47-5205835 | ||
Entity Incorporation, State or Country Code | NV | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Shell Company | false | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Entity Public Float | $ 106 | ||
Entity Contact Personnel [Line Items] | |||
Entity Address, Address Line One | 225 NE Mizner Blvd | ||
Entity Address, Address Line Two | Suite 640 | ||
Entity Address, City or Town | Boca Raton | ||
Entity Address, State or Province | FL | ||
Entity Address, Postal Zip Code | 33432 | ||
Entity Phone Fax Numbers [Line Items] | |||
City Area Code | (858) | ||
Local Phone Number | 964 3720 | ||
Entity Listings [Line Items] | |||
Title of 12(b) Security | Common Stock ($0.001 par value) | ||
Trading Symbol | INMB | ||
Security Exchange Name | NASDAQ | ||
Entity Common Stock, Shares Outstanding | 18,026,473 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2023 | |
Auditor [Table] | |
Auditor Name | Marcum llp |
Auditor Firm ID | 688 |
Auditor Location | Houston, Texas |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
CURRENT ASSETS | ||
Cash and cash equivalents | $ 35,848 | $ 52,153 |
Research and development tax credit receivable | 1,905 | 8,099 |
Other tax receivable | 537 | 362 |
Prepaid expenses and other current assets | 1,510 | 4,027 |
TOTAL CURRENT ASSETS | 39,942 | 64,675 |
Operating lease – right of use assets | 414 | 507 |
Other assets | 131 | 99 |
Acquired in-process research and development intangible assets | 16,514 | 16,514 |
TOTAL ASSETS | 57,001 | 81,795 |
CURRENT LIABILITIES | ||
Accounts payable and accrued liabilities | 7,901 | 5,206 |
Deferred liabilities | 489 | 616 |
Current portion of long-term debt, net | 9,921 | 5,000 |
Operating lease, current liabilities | 119 | 87 |
TOTAL CURRENT LIABILITIES | 18,465 | 10,918 |
Long-term debt, net | 9,697 | |
Long-term operating lease liabilities | 397 | 526 |
Accrued liability – long-term | 550 | |
TOTAL LIABILITIES | 18,862 | 21,691 |
COMMITMENTS AND CONTINGENCIES | ||
Redeemable common stock, $0.001 par value; 75,697 and 0 shares issued and outstanding, respectively (Note 9) | 799 | |
STOCKHOLDERS’ EQUITY | ||
Common stock, $0.001 par value, 200,000,000 shares authorized,17,950,776 and 17,945,995 shares issued and outstanding, respectively | 18 | 18 |
Additional paid-in capital | 159,143 | 151,799 |
Accumulated other comprehensive loss | (799) | (699) |
Accumulated deficit | (121,022) | (91,014) |
TOTAL STOCKHOLDERS’ EQUITY | 37,340 | 60,104 |
TOTAL LIABILITIES, REDEEMABLE COMMON STOCK AND STOCKHOLDERS’ EQUITY | 57,001 | 81,795 |
Related Party | ||
CURRENT ASSETS | ||
Prepaid expenses – related party | 142 | 34 |
CURRENT LIABILITIES | ||
Accounts payable and accrued liabilities – related parties | $ 35 | $ 9 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Redeemable common stock par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Redeemable common stock shares issued | 75,697 | 0 |
Redeemable common stock shares outstanding | 75,697 | 0 |
Preferred stock par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 17,950,776 | 17,945,995 |
Common stock, shares outstanding | 17,950,776 | 17,945,995 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Statement [Abstract] | ||
REVENUE | $ 155 | $ 374 |
OPERATING EXPENSES | ||
General and administrative | 9,623 | 9,258 |
Research and development | 20,273 | 17,067 |
Total operating expenses | 29,896 | 26,325 |
LOSS FROM OPERATIONS | (29,741) | (25,951) |
OTHER EXPENSE, NET | ||
Other expense, net | (267) | (1,348) |
Total other expense, net | (267) | (1,348) |
NET LOSS | $ (30,008) | $ (27,299) |
Net loss per common share – basic and diluted (in Dollars per share) | $ (1.67) | $ (1.52) |
Weighted average number of common shares outstanding – basic and diluted (in Shares) | 17,980,791 | 17,927,327 |
COMPREHENSIVE LOSS | ||
Net loss | $ (30,008) | $ (27,299) |
Other comprehensive loss – foreign currency translation | (100) | (700) |
Total comprehensive loss | $ (30,108) | $ (27,999) |
Consolidated Statements of Op_2
Consolidated Statements of Operations and Comprehensive Loss (Parentheticals) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Statement [Abstract] | ||
Net loss per common share – diluted | $ (1.67) | $ (1.52) |
Weighted average common shares outstanding – diluted | 17,980,791 | 17,927,327 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income Loss | Accumulated Deficit | Total |
Balance at Dec. 31, 2021 | $ 18 | $ 143,921 | $ 1 | $ (63,715) | $ 80,225 |
Balance (in Shares) at Dec. 31, 2021 | 17,843,303 | ||||
Issuance of common stock for cash, net | 699 | 699 | |||
Issuance of common stock for cash, net (in Shares) | 82,900 | ||||
Exercise of warrants for cash | 30 | $ 30 | |||
Exercise of warrants for cash (in Shares) | 19,792 | ||||
Stock-based compensation | 7,149 | $ 7,149 | |||
Loss on foreign currency translation | (700) | (700) | |||
Net loss | (27,299) | (27,299) | |||
Balance at Dec. 31, 2022 | $ 18 | 151,799 | (699) | (91,014) | $ 60,104 |
Balance (in Shares) at Dec. 31, 2022 | 17,945,995 | 17,945,995 | |||
Issuance of common stock for cash, net | 775 | $ 775 | |||
Issuance of common stock for cash, net (in Shares) | 75,697 | ||||
Reclassification to redeemable common stock | (799) | (799) | |||
Reclassification to redeemable common stock (in Shares) | (75,697) | ||||
Cashless exercise of warrants | |||||
Cashless exercise of warrants (in Shares) | 4,781 | ||||
Stock-based compensation | 7,368 | 7,368 | |||
Loss on foreign currency translation | (100) | (100) | |||
Net loss | (30,008) | (30,008) | |||
Balance at Dec. 31, 2023 | $ 18 | $ 159,143 | $ (799) | $ (121,022) | $ 37,340 |
Balance (in Shares) at Dec. 31, 2023 | 17,950,776 | 17,950,776 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (30,008) | $ (27,299) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 7,368 | 7,149 |
Impairment of right of use asset | 89 | |
Accretion of debt discount | 224 | 239 |
Changes in operating assets and liabilities: | ||
Research and development tax credit receivable | 6,194 | (3,186) |
Other tax receivable | (175) | 229 |
Prepaid expenses and other current assets | 2,517 | (1,749) |
Prepaid expenses – related party | (108) | (20) |
Other assets | (32) | |
Accounts payable and accrued liabilities | 2,695 | 1,473 |
Accounts payable and accrued liabilities – related parties | 26 | (71) |
Deferred liabilities | (127) | 142 |
Accrued liability – long-term | (550) | 351 |
Operating lease liabilities | (4) | (33) |
Net cash used in operating activities | (11,980) | (22,686) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Net proceeds from sale of common stock | 775 | 699 |
Repayment of debt | (5,000) | |
Net proceeds from the exercise of warrants | 30 | |
Net cash (used in) provided by financing activities | (4,225) | 729 |
Impact on cash from foreign currency translation | (100) | (700) |
NET DECREASE IN CASH | (16,305) | (22,657) |
CASH AT BEGINNING OF YEAR | 52,153 | 74,810 |
CASH AT END OF YEAR | 35,848 | 52,153 |
SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | ||
Cash paid for income taxes | ||
Cash paid for interest expense | $ 1,778 | $ 1,372 |
Organization and Basis of Prese
Organization and Basis of Presentation | 12 Months Ended |
Dec. 31, 2023 | |
Organization and Basis of Presentation [Abstract] | |
ORGANIZATION AND BASIS OF PRESENTATION | NOTE 1 Organization and Business Overview INmune Bio Inc. (the “Company” or “INmune Bio”) was organized in the State of Nevada on September 25, 2015 and is a clinical stage biotechnology pharmaceutical company focused on developing and commercializing its product candidates to treat diseases where the innate immune system is not functioning normally and contributing to the patient’s disease. INmune Bio has two product platforms. The DN-TNF product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases. DN-TNF is currently being developed for Alzheimer’s and treatment resistant depression (“XPro”) and cancer (“INB03”) and an out-licensing strategy. The Natural Killer Cell Priming Platform includes INKmune aimed at priming the patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic malignancies, solid tumors and chronic inflammation. Basis of Presentation and Principles of Consolidation The accompanying consolidated financial statements of the Company have been prepared in accordance with Generally Accepted Accounting Principles (“US GAAP”) in the United States of America and the rules of the Securities and Exchange Commission (“SEC”). The consolidated financial statements herein have been prepared in accordance with US GAAP and include the accounts of INmune Bio, its wholly-owned UK subsidiary, and its wholly-owned Australia subsidiary (collectively, the “Company”). All significant intercompany accounts and transactions have been eliminated. |
Going Concern
Going Concern | 12 Months Ended |
Dec. 31, 2023 | |
Going Concern [Abstract] | |
GOING CONCERN | NOTE 2 These consolidated financial statements have been prepared in accordance with generally accepted accounting principles applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred significant losses and negative cash flows from operations since inception and expects to incur additional losses until such time that it can generate significant revenue from the commercialization of its product candidates. The Company had net losses of approximately $30.0 million and $27.3 million and negative cash flows from operating activities of approximately $12.0 million and $22.7 million for the years ended December 31, 2023 and 2022, respectively, and an accumulated deficit of approximately $121.0 million and $91.0 million as of December 31, 2023 and 2022, respectively. Given the Company’s projected operating requirements and its existing cash and cash equivalents, the Company is projecting insufficient liquidity to sustain its operations through one year following the date that the financial statements are issued. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern. In response to these conditions, management is currently evaluating different strategies to obtain the required funding of future operations. Financing strategies may include, but are not limited to, the public or private sale of equity, debt financings or funds from other capital sources, such as government funding, collaborations, strategic alliances, divestment of non-core assets, or licensing arrangements with third parties. There can be no assurances that the Company will be able to secure additional financing, or if available, that it will be sufficient to meet its needs or on favorable terms. Because management’s plans have not yet been finalized and are not within the Company’s control, the implementation of such plans cannot be considered probable. As a result, the Company has concluded that management’s plans do not alleviate substantial doubt about the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Summary of Significant Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 3 Use of Estimates Preparing financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses. Actual results and outcomes may differ from management’s estimates and assumptions. Fair Value of Financial Instruments The Company measures certain assets and liabilities in accordance with authoritative guidance which requires fair value measurements to be classified and disclosed in one of the following three categories: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. Level 2: Observable prices that are based on inputs not quoted on active markets but corroborated by market data. Level 3: Unobservable inputs are used when little or no market data is available. Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. The Company reviews the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets or liabilities within the fair value hierarchy. The Company did not have any transfers of assets and liabilities between the levels of the fair value measurement hierarchy during the years presented. The carrying amounts of financial instruments such as cash and cash equivalents, research and development tax credit receivable, other receivable, prepaid expenses, and accounts payable and accrued liabilities approximate the related fair values due to the short-term maturities of these instruments. Risks and Uncertainties The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical studies, clinical trials and regulatory approval prior to commercialization. These efforts require significant amounts of additional resources, adequate personnel, infrastructure and extensive compliance and reporting. The Company’s product candidates are still in development and, to date, none of the Company’s product candidates have been approved for sale. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained or maintained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate any revenue from any of its products. The Company operates in an environment of rapid change in technology and substantial competition from other pharmaceutical and biotechnology companies. The Company relies and expects to continue to rely on a small number of vendors to manufacture supplies and materials for its use in the clinical trial programs. These programs could be adversely affected by a significant interruption in these manufacturing services. Cash and Cash Equivalents The Company considers all highly liquid instruments purchased with an original maturity of three months or less to be cash equivalents. The Company holds cash in banks in excess of Federal Deposit Insurance Corporation insurance limits. However, the Company believes risk of loss is minimal as the cash is held by large, highly-rated financial institutions. Research and Development Tax Incentive Receivable The Company, through its wholly-owned subsidiary in Australia, participates in the Australian research and development tax incentive program, such that a percentage of our qualifying research and development expenditures are reimbursed by the Australian government, and such incentives are reflected as a reduction of research and development expense. The Australian research and development tax incentive is recognized when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the amount of the consideration can be reliably measured. At each period end, management estimates the reimbursement available to the Company based on available information at the time. The Company, through its wholly-owned subsidiary in the United Kingdom, participates in the research and development program provided by the United Kingdom tax relief program, such that a percentage of our qualifying research and development expenditures are reimbursed by the United Kingdom government, and such incentives are reflected as a reduction of research and development expense. The United Kingdom research and development tax incentive is recognized when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the amount of the consideration can be reliably measured. At each period end, management estimates the reimbursement available to the Company based on available information at the time. Intangible Assets The Company capitalizes costs incurred in connection with in-process research and development purchased from others if the asset has alternative uses and such uses are not restricted under applicable license agreements; patent applications (principally legal fees), patent purchases, and trademarks related to its cell line as intangible assets. Acquired in-process research and development costs that do not have alternative uses are expensed as incurred. When the assets are determined to have a finite life (upon completion of the development of the in-process research and development for its DN-TNF platform), the useful life will be determined, and the in-process research and development intangible assets will be amortized. During the fourth quarter and if business factors indicate more frequently, the Company performs an assessment of the qualitative factors affecting the fair value of our in-process research and development. If the qualitative assessment suggests that impairment is more likely than not, a quantitative analysis is performed. The quantitative analysis involves a comparison of the fair value of the in-process research and development with the carrying amount. If the carrying amount of the in-process research and development exceeds its fair value, an impairment loss is recognized in an amount equal to that excess. During the years ended December 31, 2023 and 2022, the Company performed a qualitative assessment of its in-process research and development and determined that there were no indicators of impairment. Basic and Diluted Loss per Share Basic loss per share is computed by dividing net loss available to common shareholders by the weighted average number of outstanding common shares during the period. Diluted loss per share gives effect to all dilutive potential common shares outstanding during the period. Dilutive loss per share excludes all potential common shares if their effect is anti-dilutive. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. At December 31, 2023, the Company had 5,496,000 potentially issuable shares of common stock upon the exercise of stock options and 45,386 potentially issuable shares of common stock upon the exercise of warrants. At December 31, 2022, the Company had 4,841,417 potentially issuable shares of common stock upon the exercise of stock options and 74,074 potentially issuable shares of common stock upon the exercise of warrants. Revenue Recognition The Company recognizes revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. The Company recognizes revenue following the five-step model prescribed under ASC Topic 606: (1) identify contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenues when (or as) the Company satisfies the performance obligations. The Company records the expenses related to revenue in research and development expense, in the periods such expenses were incurred. The Company records deferred revenues when cash payments are received or due in advance of performance, including amounts which are refundable. The Company’s 2023 and 2022 revenue was from the sale of MSC’s to one customer and was recognized when the MSC’s were delivered to the customers. Stock-Based Compensation The Company utilizes the Black-Scholes option pricing model to estimate the fair value of stock option awards at the date of grant, which requires the input of highly subjective assumptions, including expected volatility and expected life. Changes in these inputs and assumptions can materially affect the measure of estimated fair value of our share-based compensation. These assumptions are subjective and generally require significant analysis and judgment to develop. When estimating fair value, some of the assumptions will be based on, or determined from, external data and other assumptions may be derived from our historical experience with stock-based payment arrangements. The appropriate weight to place on historical experience is a matter of judgment, based on relevant facts and circumstances. The Company accounts for forfeitures of stock options as they occur. Research and Development Research and development (“R&D”) costs are expensed as incurred. Research and development credits are recorded by the Company as a reduction of research and development costs. Major components of research and development costs include cash compensation, stock-based compensation, clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, costs of pre-clinical trials, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf. The Company recognizes grants as contra research and development expense in the consolidated statement of operations on a systematic basis over the periods in which the entity recognizes as expenses the related costs for which the grants are intended to compensate. Income Taxes The Company follows the liability method of accounting for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the estimated tax consequences attributable to differences between the financial statement carrying values and their respective income tax basis (temporary differences). The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Foreign Currency Translation The Company’s financial statements are presented in the U.S. dollar (“$”), which is the Company’s reporting currency, while its functional currencies are the U.S. Dollar for its U.S. based operations, British Pound (“GBP”) for its United Kingdom-based operations and Australian Dollars (“AUD”) for its Australian-based operations. All assets and liabilities are translated at the exchange rate on the balance sheet date, stockholders’ equity is translated at historical rates and statement of operations items are translated at the weighted average exchange rate for the period. The resulting translation adjustments are reported under other comprehensive income. Gains and losses resulting from the translations of foreign currency transactions and balances are reflected in the statement of operations and comprehensive loss. Recent Accounting Pronouncements In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures Subsequent Events The Company has evaluated all transactions through the financial statement issuance date for subsequent disclosure consideration. |
Research and Development Activi
Research and Development Activity | 12 Months Ended |
Dec. 31, 2023 | |
Research and Development Activity [Abstract] | |
RESEARCH AND DEVELOPMENT ACTIVITY | NOTE 4 According to UK tax law, the Company is allowed an R&D tax credit that reduces a company’s tax bill in the UK for expenses incurred in R&D subject to certain requirements. The Company’s UK subsidiary submits R&D tax credit requests annually for research and development expenses incurred. At December 31, 2023 and 2022, the Company had a research and development tax credit receivable of $0 and $2,690,000, respectively for R&D expenses incurred in the UK. During the years ended December 31, 2023 and 2022, the Company received $2,710,000 and $0 of R&D tax credit reimbursements, respectively from the UK. According to AUS tax law, the Company is allowed an R&D tax credit that reduces a company’s tax bill in AUS for expenses incurred in R&D subject to certain requirements. The Company’s Australian subsidiary submits R&D tax credit requests annually for research and development expenses incurred. At December 31, 2023 and 2022, the Company had a research and development tax credit receivable of $1,905,000 and $5,409,000, respectively, for R&D expenses incurred in Australia. During the years ended December 31, 2023 and 2022, the Company received $6,557,000 and $0 of R&D tax credit reimbursements, respectively from Australia. Xencor, Inc. License Agreement On October 3, 2017, the Company entered into a license agreement (“Xencor License Agreement”) with Xencor, Inc. (“Xencor”), which discovered and developed a proprietary biological molecule that inhibits soluble tumor necrosis factor. On June 10, 2021, the Company and Xencor entered into a First Amendment to License Agreement pursuant to which, among other things, Section 3.2 of the Xencor License Agreement was amended to change the due diligence milestones. Pursuant to the Xencor License Agreement, Xencor granted the Company an exclusive worldwide, royalty-bearing license in licensed patent rights, licensed know-how and licensed materials (as defined in the license agreement) to make, develop, use, sell and import any pharmaceutical product that comprises, contains, or incorporates Xencor’s proprietary protein known as “XPro” that inhibits soluble tumor necrosis factor (or all modifications, formulations and variants of the licensed protein that specifically bind soluble tumor necrosis factor) alone or in combination with one or more active ingredients, in any dosage or formulation (“Licensed Products”). The Company believes the protein has numerous medical applications. Such additional alternative applications of the technology are available under the Xencor License Agreement. The Company also agreed to pay Xencor a 5 % royalty on Net Sales of all Licensed Products in a given calendar year, which are payable on a country-by- country and licensed product by licensed product basis until the date that is the later of (a) the expiration of the last to expire valid claim covering such Licensed Product in such country or (b) ten years following the first sale to a third party of the licensed product in such country. INKmune License Agreement On October 29, 2015, the Company entered into an exclusive license agreement (the “INKmune License Agreement”) with Immune Ventures, LLC (“Immune Ventures”). Pursuant to the INKmune License Agreement, the Company was granted exclusive worldwide rights to the patents, including rights to incorporate any improvements or additions to the patents that may be developed in the future. In consideration for the patent rights, the Company agreed to the following milestone payments: (in thousands) Each Phase I initiation $ 25 Each Phase II initiation $ 250 Each Phase III initiation $ 350 Each NDA/EMA filing $ 1,000 Each NDA/EMA awarded $ 9,000 In addition, the Company agreed to pay the licensor a royalty of 1% of net sales during the life of each patent granted to the Company. The License is owned by Immune Ventures. RJ Tesi, the Company’s President and a member of our Board of Directors, David Moss, its Chief Financial Officer and Treasurer and Mark Lowdell, its Chief Scientific Officer, are the owners of Immune Ventures. No sales have occurred under this license. During December 2023, the Company initiated a Phase I trial with INKmune in patients with metastatic castration-resistant prostate cancer and has recorded a $25,000 payable to Immune Ventures as of December 31, 2023. The term of the agreement began on October 29, 2015 and ends on a country-by-country basis on the date of the expiration of the last to expire patent rights where patent rights exists, unless terminated earlier in accordance with the agreement. Upon the termination of the agreement, we shall have a fully paid up, perpetual, royalty-free license without further obligation to Immune Ventures. The agreement can be terminated by Immune Ventures if, after 60 days from the Company’s receipt of notice that the Company has not made a payment under the agreement, and the Company still does not make this payment. On July 20, 2018 and October 30, 2020, the parties amended the agreement under which the Company was required achieve milestones pursuant to the agreement. On April 17, 2023, the parties executed an additional amendment to the agreement under which the Company removed the due diligence requirements to achieve reasonable commercial efforts to bring INKmune to market. This removed all requirements of clinical trial timelines and the filing timelines of an NDA or equivalent. All other provisions in the INKmune License Agreement shall continue in full force and effect. University of Pittsburg License Agreement On October 3, 2017, the Company entered into an Assignment and Assumption Agreement with Immune Ventures related to intellectual property licensed from the University of Pittsburgh. Pursuant to the Assignment and Assumption Agreement (“Assignment Agreement”), Immune Ventures assigned all of its rights, obligations and liabilities under an Exclusive License Agreement between the University of Pittsburgh – Of the Commonwealth System of Higher Education (“Licensor”) and Immune Ventures to INmune Bio (“Licensee”), (the “PITT Agreement”). Consideration under the PITT Agreement includes: (i) annual maintenance fees, (ii) royalty payments based on the sale of products making use of the licensed technology, and (iii) milestone payments. Annual maintenance fees under the PITT Agreement include: $10,000 due on June 26 of each year 2023-2024; and $25,000 due on June 26 of each year 2025 and annually thereafter until first commercial sale. The Company had no amounts owed pursuant to the PITT Agreement as of December 31, 2023. Upon first commercial sale of a product making use of the licensed technology under the PITT Agreement, the Licensee is required to pay royalties equal to 2.5% of Net Sales each calendar quarter. As of December 31, 2023, there have been no commercial sales of product making use of the licensed technology under the PITT Agreement. Moreover, under the PITT Agreement the Licensee is required to make milestone payments as follows: (in thousands) Each Phase I initiation $ 50 Each Phase III initiation $ 500 First commercial sale of product making use of licensed technology $ 1,250 The PITT Agreement expires upon the earlier of: (i) expiration of the last claim of the Patent Rights forming the subject matter of the PITT Agreement; or (ii) the date that is 20 years from the effective date of the agreement (June 26, 2037). The Licensee may terminate the PITT Agreement upon 3 months prior written notice provided all payments under the license are current. The Licensor may terminate the PITT Agreement upon written notice if: (i) Licensee defaults as to performance of material obligations which have not been cured within 60 days after receiving written notice; or (ii) Licensee ceases to carry out its business, becomes bankrupt or insolvent, applies for or consents to the appointment of a trustee, receiver or liquidator of its assets or seeks relief under any law for the aid of debtors. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Measurements [Abstract] | |
FAIR VALUE MEASUREMENTS | NOTE 5 The following table presents the hierarchy for assets and liabilities measured at fair value on a recurring basis: (in thousands) Total Quoted Significant Significant December 31, 2023: Cash equivalents Money market fund $ 35,162 $ 35,162 $ - $ - Total cash equivalents $ 35,162 $ 35,162 $ - $ - (in thousands) Total Quoted Significant Significant December 31, 2022: Cash equivalents Money market fund $ 51,058 $ 51,058 $ - $ - Total cash equivalents $ 51,058 $ 51,058 $ - $ - |
Lease
Lease | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
LEASE | NOTE 6 In September 2021, the Company signed a lease with a third party for office space in Boca Raton, Florida. The lease agreement has a 64-month term and commenced during the fourth quarter of 2021. Below is a summary of the Company’s right-of-use assets and liabilities: (in thousands, except years and rate) December 31, December 31, Right-of-use asset $ 414 $ 507 Operating lease, current liability 119 87 Long-term operating lease liability 397 526 Total lease liability $ 516 $ 613 Weighted-average remaining lease term 3.3 years 4.3 years Weighted-average discount rate 12.0 % 12.0 % |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | NOTE 7 UCL During the years ended December 31, 2023 and 2022, the Company paid UCL $573,000 and $586,000, respectively, for medical research performed on behalf of the Company. UCL is a wholly owned subsidiary of the University of London. The Company’s Chief Scientific and Manufacturing Officer is a professor at the University of London. CTI During 2022, the Company paid CTI $153,000 pursuant to its former sublease agreement with CTI and $5,000 for research and development performed on behalf of the Company. The Company had no transactions with CTI in 2023. AmplifyBio During the years ended December 31, 2023 and 2022, the Company paid AmplifyBio $77,000 and $230,000, respectively, to perform certain research and development on behalf of the Company. The CEO of AmplifyBio is on the Board of Directors of the Company. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2023 | |
Debt [Abstract] | |
DEBT | NOTE 8 On June 10, 2021, the Company entered into a Loan and Security Agreement (the “Term Loan”) with Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P., together (the “Lenders”). The Term Loan provides for a $15.0 million term loan, of which the Company borrowed the entire amount on June 10, 2021 and is secured by the Company’s assets. The Term Loan also provides for the Company to request an additional $5.0 million term loan from the Lenders, which may be granted or denied at the sole discretion of the Lenders. The term loan and debt discount are as follows as of December 31, 2023: (in thousands) Current portion of debt $ 10,000 Less: debt discount (79 ) Current portion of debt, net $ 9,921 For the years ended December 31, 2023 and 2022, the Company recognized interest expense of $2,278,000 and $2,014,000, respectively, related to the Term Loan. The Term Loan provides for an annual interest rate equal to the greater of (i) the prime rate then in effect as reported in The Wall Street Journal plus 4.50% and (ii) 7.75%. At December 31, 2023, the interest rate was 13.0%. The Term Loan includes a final payment fee equal to 6.5% of the original principal amount borrowed payable on the earlier of the repayment of the loan in full and the maturity date. The Company has the option to prepay the outstanding balance of the term loan in full, subject to a prepayment premium of 1% of the original principal amount borrowed for any prepayment before the maturity date. Upon the occurrence of certain events, including but not limited to the Company’s failure to satisfy its payment obligations under the Term Loan, the breach of certain of its other covenants under the Term Loan, or the occurrence of a material adverse change, the Lenders will have the right, among other remedies, to declare all principal and interest immediately due and payable, and will have the right to receive the final payment fee and, if the payment of principal and interest is due prior to maturity, the applicable prepayment fee. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders' Equity [Abstract] | |
STOCKHOLDERS’ EQUITY | NOTE 9 Common Stock – At the Market Offering During March 2021, the Company entered into a sales agreement (“Sales Agreement”) with BTIG, LLC (“BTIG”), as sales agent, to establish an At-The-Market (“ATM”) offering program of up to $45 million of common stock, subject to certain limitations on the amount of common stock that may be offered and sold by the Company set forth in the sales agreement. During August 2023, the Company and BTIG entered into Amendment No. 1 to the Sales Agreement. The Company is required to pay BTIG a commission of 3% of the gross proceeds from the sale of shares. During July 2023, the Company sold 75,697 shares of its common stock at an average price of $10.56 per share under the ATM program. The aggregate net proceeds were approximately $775,000 after offering expenses. These shares were inadvertently sold under a registration statement filed with the SEC that had in fact expired prior to the time the shares were sold. Consequently, the Company may be subject to claims for rescission by purchasers who purchased shares of common stock under the ATM program. Under Section 12(a)(1) of the Securities Act, a purchaser of security in a transaction made in violation of Section 5 of the Securities Act may obtain recovery of the consideration paid in connection with its purchase, plus statutory interest, or, if it had already sold the shares, recover damages resulting from its purchase. While the Company believes, it is unlikely that a successful claim will be asserted against the Company by any purchasers who purchased shares of common stock under the ATM Agreement in July 2023, the Company cannot guarantee that no such legal claims will be asserted against the Company by any purchasers. In addition, the Company could become subject to enforcement actions and/or penalties and fines by federal authorities, and the Company is unable to predict the likelihood of any such enforcement actions being brought, or the amount of any such potential penalties or fines. As of December 31, 2023, there have been no claims or demands to exercise such rights. As a result of these potential rescission rights, the Company reclassified 75,697 shares, with an aggregate purchase price of $799,000 of its common stock as temporary equity presented outside stockholders’ equity. The reclassification of these shares shall remain for a period of one year from transaction date. These shares have been treated as issued and outstanding for financial reporting purposes. At December 31, 2023, the Company has $28.7 million of common stock available under the ATM program. Common Stock – Issuance to Directors and Officers During the year ended December 31, 2022, directors and officers of the Company purchased 82,900 shares of the Company’s common stock from the Company at $8.43 per share (which was the closing price of the Company’s common stock on March 22, 2022) for gross proceeds of $699,000. Stock options On June 1, 2023, the Company’s shareholders approved an amendment to the 2021 Incentive Stock Plan (“2021 Amended and Restated Incentive Stock Plan”) to increase the shares of the Company’s common stock available for issuance thereunder to 4,000,000 shares. During 2023, the Company granted certain employees and directors options to purchase 665,000 shares of its common stock pursuant to the 2017 and 2019 Incentive Stock Plans and 2021 Amended and Restated Incentive Stock Plan. The stock options had a fair value of approximately $4.9 million that was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 3.84% – 3.99% based on the applicable US Treasury bill rate (2) expected life of 6.0 – 6.25 years, (3) expected volatility of approximately 91% based on the trading history of similar companies, and (4) zero expected dividends. During 2022, the Company granted certain employees and directors options to purchase 819,000 shares of its common stock pursuant to the 2021 Incentive Stock Plan. The stock options had a fair value of approximately $5.5 million that was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 1.60% - 3.06% based on the applicable US Treasury bill rate (2) expected life of 6.0 – 10.0 At December 31, 2023, the Company had 1,952,525 shares reserved for issuance pursuant to the 2021 Amended and Restated Incentive Stock Plan. The following table summarizes stock option activity: (in thousands, except share and per share amounts) Number of Weighted- Weighted- Aggregate Outstanding at December 31, 2021 4,097,000 $ 8.67 7.21 - Options granted 819,000 $ 8.01 10.0 - Options exercised - $ - - - Options cancelled (74,583 ) $ 11.68 - - Outstanding at December 31, 2022 4,841,417 $ 8.60 6.28 - Options granted 665,000 $ 9.69 10.0 - Options cancelled (10,417 ) $ 12.44 - - Outstanding at December 31, 2023 5,496,000 $ 8.73 6.18 $ 21,509 Exercisable at December 31, 2023 4,319,605 $ 8.16 5.67 $ 19,354 During the years ended December 31, 2023 and 2022, the Company recognized stock-based compensation expense of $7,368,000 and $7,149,000, respectively, related to stock options. As of December 31, 2023, there was $8,592,000 of total unrecognized compensation cost related to non-vested stock options which is expected to be recognized over a weighted-average period of 2.05 years. Warrants The Company issued warrants to the Company’s lenders upon obtaining its loan in June 2021. The warrants have a 10-year term and an exercise price of $14.05. At December 31, 2023 and 2022, respectively, 45,386 of these warrants are outstanding and the intrinsic value of these warrants is $0. During the year ended December 31, 2023, a third party exercised 28,688 warrants on a cashless basis in exchange for 4,781 shares of common stock. During the year ended December 31, 2022, a third party exercised 19,792 warrants in exchange for 19,792 shares of common stock for cash proceeds of approximately $30,000. Stock-based Compensation by Class of Expense The following summarizes the components of stock-based compensation expense in the consolidated statements of operations for the years ended December 31, 2023 and 2022, respectively: Year Ended Year Ended Research and development $ 2,743,000 $ 2,645,000 General and administrative 4,625,000 4,504,000 Total $ 7,368,000 $ 7,149,000 Shareholder Rights Agreement On December 30, 2020, the Board of Directors (the “Board”) of the Company approved and adopted a Rights Agreement, dated as of December 30, 2020, by and between the Company and VStock Transfer, LLC, as rights agent, pursuant to which the Board declared a dividend of one preferred share purchase right (each, a “Right”) for each outstanding share of the Company’s common stock held by stockholders as of the close of business on January 11, 2021. When exercisable, each right initially would represent the right to purchase from the Company one one-thousandth of a share of a newly designated series of preferred stock, Series A Junior Participating Preferred Stock, par value $0.001 per share, of the Company, at an exercise price of $300.00 per one one-thousandth of a Series A Junior Participating Preferred Share, subject to adjustment. Subject to various exceptions, the Rights become exercisable in the event any person (excluding certain exempted or grandfathered persons) becomes the beneficial owner of twenty percent or more of the Company’s common stock without the approval of the Board. The Rights Agreement was amended in 2021, 2022 and 2023 to extend the expiration date and shall expire on December 30, 2024. Preferred Stock In 2020, the Company designated 45,000 shares of its preferred stock with par value of $0.001 per share as Series A Junior Participating Preferred Stock. The remaining 9,955,000 shares of preferred stock with par value of $0.001 remain undesignated. None of the preferred shares were issued and outstanding at December 31, 2023 and 2022. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 10 The provision for income taxes consists of the following components: December 31, December 31, Current expense (benefit) $ - $ - Federal - - State - - Foreign - - Current income tax expense - - Deferred expense (benefit) - - Federal - - State - - Foreign - - Deferred income tax - - Net deferred taxes $ - $ - A reconciliation of income tax benefit computed using the federal statutory income tax rate to the Company’s tax expense is as follows: (in thousands, except percentage) December 31, December 31, Federal tax benefit at statutory rate (21%) $ (6,302 ) $ (5,733 ) Stock-based compensation 1,143 1,049 State income tax benefit, net of federal tax effect (222 ) (269 ) Foreign tax differential (241 ) (237 ) Research credits 266 18 Other 3 3 Return to provision adjustment 335 (1,774 ) Change in valuation allowance 5,018 6,943 Income tax benefit $ - $ - The principal components of deferred tax assets and liabilities consist of the following at December 31, 2023 and 2022, respectively: (in thousands) December 31, December 31, Deferred tax assets Stock-based compensation $ 2,208 $ 1,386 Research and development 2,900 1,114 Federal NOL carryforwards 6,849 5,441 State NOL carryforwards 1,685 1,487 Foreign NOL carryforwards 5,965 4,307 Total deferred tax assets 19,607 13,735 Less valuation allowance (19,607 ) (13,735 ) Net deferred tax assets $ - $ - At December 31, 2023, the Company had a federal net operating loss carryforward of approximately $32.6 million. The net operating loss carryforwards for 2017 will begin to expire in the year ending December 31, 2037. The net operating loss carryforwards starting in 2018 have no expiration. The Company’s gross deferred tax assets of $19.6 million and $13.7 million at December 31, 2023 and 2022, respectively, primarily consist of net operating loss carryforwards for income tax purposes. A valuation allowance is required to be recorded when it is not more likely than not that some portion or all of the net deferred tax assets will be realized. Since the Company cannot be assured of generating taxable income and thereby realizing the net deferred tax assets, a full valuation allowance has been recorded. The change in the valuation allowance was $5,872,000 during the year ended December 31, 2023. The Company recognizes uncertain tax positions in accordance with ASC 740 on the basis of evaluating whether it is more likely than not that the tax positions will be sustained upon examination by tax authorities. For those tax positions that meet the more-likely-than not recognition threshold, we recognize the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement. As of December 31, 2023, and 2022, the Company has no significant uncertain tax positions. There are no unrecognized tax benefits included on the balance sheet that would, if recognized, impact the effective tax rate. The Company does not anticipate there will be a significant change in unrecognized tax benefits within the next 12 months. |
Collaborative Agreements
Collaborative Agreements | 12 Months Ended |
Dec. 31, 2023 | |
Collaborative Agreements [Abstract] | |
COLLABORATIVE AGREEMENTS | NOTE 11 During September 2020, the Company was awarded a grant of up to $2.9 million from the National Institutes of Health (“NIH”). The grant will support a Phase 2 study of XPro in patients with treatment resistant depression. As of December 31, 2023, the Company has not received any proceeds pursuant to this grant. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 12 Lease During September 2021, the Company signed a lease agreement with a third party for office space in Boca Raton, Florida. The operating lease has a 64-month term and commenced during the fourth quarter of 2021. Future minimum payments pursuant to the leases are as follows: (in thousands, except years) 2024 $ 186 2025 193 2026 198 2027 51 Total lease payments 628 Less: imputed interest (112 ) Present value of future lease payments 516 Less: operating lease, current liabilities (119 ) Long-term operating lease liabilities $ 397 During the years ended December 31, 2023 and 2022, the Company recognized $163,000 and $209,000, respectively, in operating lease expense, which is included in general and administrative expenses in the Company’s consolidated statement of operations. Litigation The Company is subject to claims and suits that arise from time to time in the ordinary course of our business. Although management currently believes that resolving claims against the Company, individually or in aggregate, will not have a material adverse impact in the Company’s consolidated financial statements, these matters are subject to inherent uncertainties and management’s view of these matters may change in the future. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (30,008) | $ (27,299) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
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 |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Summary of Significant Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates Preparing financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses. Actual results and outcomes may differ from management’s estimates and assumptions. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company measures certain assets and liabilities in accordance with authoritative guidance which requires fair value measurements to be classified and disclosed in one of the following three categories: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. Level 2: Observable prices that are based on inputs not quoted on active markets but corroborated by market data. Level 3: Unobservable inputs are used when little or no market data is available. Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. The Company reviews the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets or liabilities within the fair value hierarchy. The Company did not have any transfers of assets and liabilities between the levels of the fair value measurement hierarchy during the years presented. The carrying amounts of financial instruments such as cash and cash equivalents, research and development tax credit receivable, other receivable, prepaid expenses, and accounts payable and accrued liabilities approximate the related fair values due to the short-term maturities of these instruments. |
Risks and Uncertainties | Risks and Uncertainties The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical studies, clinical trials and regulatory approval prior to commercialization. These efforts require significant amounts of additional resources, adequate personnel, infrastructure and extensive compliance and reporting. The Company’s product candidates are still in development and, to date, none of the Company’s product candidates have been approved for sale. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained or maintained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate any revenue from any of its products. The Company operates in an environment of rapid change in technology and substantial competition from other pharmaceutical and biotechnology companies. The Company relies and expects to continue to rely on a small number of vendors to manufacture supplies and materials for its use in the clinical trial programs. These programs could be adversely affected by a significant interruption in these manufacturing services. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid instruments purchased with an original maturity of three months or less to be cash equivalents. The Company holds cash in banks in excess of Federal Deposit Insurance Corporation insurance limits. However, the Company believes risk of loss is minimal as the cash is held by large, highly-rated financial institutions. |
Research and Development Tax Incentive Receivable | Research and Development Tax Incentive Receivable The Company, through its wholly-owned subsidiary in Australia, participates in the Australian research and development tax incentive program, such that a percentage of our qualifying research and development expenditures are reimbursed by the Australian government, and such incentives are reflected as a reduction of research and development expense. The Australian research and development tax incentive is recognized when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the amount of the consideration can be reliably measured. At each period end, management estimates the reimbursement available to the Company based on available information at the time. The Company, through its wholly-owned subsidiary in the United Kingdom, participates in the research and development program provided by the United Kingdom tax relief program, such that a percentage of our qualifying research and development expenditures are reimbursed by the United Kingdom government, and such incentives are reflected as a reduction of research and development expense. The United Kingdom research and development tax incentive is recognized when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the amount of the consideration can be reliably measured. At each period end, management estimates the reimbursement available to the Company based on available information at the time. |
Intangible Assets | Intangible Assets The Company capitalizes costs incurred in connection with in-process research and development purchased from others if the asset has alternative uses and such uses are not restricted under applicable license agreements; patent applications (principally legal fees), patent purchases, and trademarks related to its cell line as intangible assets. Acquired in-process research and development costs that do not have alternative uses are expensed as incurred. When the assets are determined to have a finite life (upon completion of the development of the in-process research and development for its DN-TNF platform), the useful life will be determined, and the in-process research and development intangible assets will be amortized. During the fourth quarter and if business factors indicate more frequently, the Company performs an assessment of the qualitative factors affecting the fair value of our in-process research and development. If the qualitative assessment suggests that impairment is more likely than not, a quantitative analysis is performed. The quantitative analysis involves a comparison of the fair value of the in-process research and development with the carrying amount. If the carrying amount of the in-process research and development exceeds its fair value, an impairment loss is recognized in an amount equal to that excess. During the years ended December 31, 2023 and 2022, the Company performed a qualitative assessment of its in-process research and development and determined that there were no indicators of impairment. |
Basic and Diluted Loss per Share | Basic and Diluted Loss per Share Basic loss per share is computed by dividing net loss available to common shareholders by the weighted average number of outstanding common shares during the period. Diluted loss per share gives effect to all dilutive potential common shares outstanding during the period. Dilutive loss per share excludes all potential common shares if their effect is anti-dilutive. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. At December 31, 2023, the Company had 5,496,000 potentially issuable shares of common stock upon the exercise of stock options and 45,386 potentially issuable shares of common stock upon the exercise of warrants. At December 31, 2022, the Company had 4,841,417 potentially issuable shares of common stock upon the exercise of stock options and 74,074 potentially issuable shares of common stock upon the exercise of warrants. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. The Company recognizes revenue following the five-step model prescribed under ASC Topic 606: (1) identify contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenues when (or as) the Company satisfies the performance obligations. The Company records the expenses related to revenue in research and development expense, in the periods such expenses were incurred. The Company records deferred revenues when cash payments are received or due in advance of performance, including amounts which are refundable. The Company’s 2023 and 2022 revenue was from the sale of MSC’s to one customer and was recognized when the MSC’s were delivered to the customers. |
Stock-Based Compensation | Stock-Based Compensation The Company utilizes the Black-Scholes option pricing model to estimate the fair value of stock option awards at the date of grant, which requires the input of highly subjective assumptions, including expected volatility and expected life. Changes in these inputs and assumptions can materially affect the measure of estimated fair value of our share-based compensation. These assumptions are subjective and generally require significant analysis and judgment to develop. When estimating fair value, some of the assumptions will be based on, or determined from, external data and other assumptions may be derived from our historical experience with stock-based payment arrangements. The appropriate weight to place on historical experience is a matter of judgment, based on relevant facts and circumstances. The Company accounts for forfeitures of stock options as they occur. |
Research and Development | Research and Development Research and development (“R&D”) costs are expensed as incurred. Research and development credits are recorded by the Company as a reduction of research and development costs. Major components of research and development costs include cash compensation, stock-based compensation, clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, costs of pre-clinical trials, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf. The Company recognizes grants as contra research and development expense in the consolidated statement of operations on a systematic basis over the periods in which the entity recognizes as expenses the related costs for which the grants are intended to compensate. |
Income Taxes | Income Taxes The Company follows the liability method of accounting for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the estimated tax consequences attributable to differences between the financial statement carrying values and their respective income tax basis (temporary differences). The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. |
Foreign Currency Translation | Foreign Currency Translation The Company’s financial statements are presented in the U.S. dollar (“$”), which is the Company’s reporting currency, while its functional currencies are the U.S. Dollar for its U.S. based operations, British Pound (“GBP”) for its United Kingdom-based operations and Australian Dollars (“AUD”) for its Australian-based operations. All assets and liabilities are translated at the exchange rate on the balance sheet date, stockholders’ equity is translated at historical rates and statement of operations items are translated at the weighted average exchange rate for the period. The resulting translation adjustments are reported under other comprehensive income. Gains and losses resulting from the translations of foreign currency transactions and balances are reflected in the statement of operations and comprehensive loss. |
Recently Adopted Accounting Pronouncements | Recent Accounting Pronouncements In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures |
Subsequent Events | Subsequent Events The Company has evaluated all transactions through the financial statement issuance date for subsequent disclosure consideration. |
Research and Development Acti_2
Research and Development Activity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Research and Development Activity [Abstract] | |
Schedule of Milestone Payments in Consideration for the Patent Rights | In consideration for the patent rights, the Company agreed to the following milestone payments: (in thousands) Each Phase I initiation $ 25 Each Phase II initiation $ 250 Each Phase III initiation $ 350 Each NDA/EMA filing $ 1,000 Each NDA/EMA awarded $ 9,000 |
Schedule of Licensee is Required to make Milestone Payments | Moreover, under the PITT Agreement the Licensee is required to make milestone payments as follows: (in thousands) Each Phase I initiation $ 50 Each Phase III initiation $ 500 First commercial sale of product making use of licensed technology $ 1,250 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Measurements [Abstract] | |
Schedule of Hierarchy for Assets and Liabilities Measured at Fair Value | The following table presents the hierarchy for assets and liabilities measured at fair value on a recurring basis: (in thousands) Total Quoted Significant Significant December 31, 2023: Cash equivalents Money market fund $ 35,162 $ 35,162 $ - $ - Total cash equivalents $ 35,162 $ 35,162 $ - $ - (in thousands) Total Quoted Significant Significant December 31, 2022: Cash equivalents Money market fund $ 51,058 $ 51,058 $ - $ - Total cash equivalents $ 51,058 $ 51,058 $ - $ - |
Lease (Tables)
Lease (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Schedule of Right-of-Use Assets and Liabilities | Below is a summary of the Company’s right-of-use assets and liabilities: (in thousands, except years and rate) December 31, December 31, Right-of-use asset $ 414 $ 507 Operating lease, current liability 119 87 Long-term operating lease liability 397 526 Total lease liability $ 516 $ 613 Weighted-average remaining lease term 3.3 years 4.3 years Weighted-average discount rate 12.0 % 12.0 % |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Debt [Abstract] | |
Schedule of Term Loan and Debt Discount | The term loan and debt discount are as follows as of December 31, 2023: (in thousands) Current portion of debt $ 10,000 Less: debt discount (79 ) Current portion of debt, net $ 9,921 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders' Equity [Abstract] | |
Schedule of Stock Option Activity | The following table summarizes stock option activity: (in thousands, except share and per share amounts) Number of Weighted- Weighted- Aggregate Outstanding at December 31, 2021 4,097,000 $ 8.67 7.21 - Options granted 819,000 $ 8.01 10.0 - Options exercised - $ - - - Options cancelled (74,583 ) $ 11.68 - - Outstanding at December 31, 2022 4,841,417 $ 8.60 6.28 - Options granted 665,000 $ 9.69 10.0 - Options cancelled (10,417 ) $ 12.44 - - Outstanding at December 31, 2023 5,496,000 $ 8.73 6.18 $ 21,509 Exercisable at December 31, 2023 4,319,605 $ 8.16 5.67 $ 19,354 |
Schedule of Stock-Based Compensation Expense | The following summarizes the components of stock-based compensation expense in the consolidated statements of operations for the years ended December 31, 2023 and 2022, respectively: Year Ended Year Ended Research and development $ 2,743,000 $ 2,645,000 General and administrative 4,625,000 4,504,000 Total $ 7,368,000 $ 7,149,000 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Provision for Income Taxes | The provision for income taxes consists of the following components December 31, December 31, Current expense (benefit) $ - $ - Federal - - State - - Foreign - - Current income tax expense - - Deferred expense (benefit) - - Federal - - State - - Foreign - - Deferred income tax - - Net deferred taxes $ - $ - |
Schedule of Reconciliation of Income Tax Benefit Computed Using the Federal Statutory Income Tax Rate to the Company’s Tax Expense | A reconciliation of income tax benefit computed using the federal statutory income tax rate to the Company’s tax expense is as follows: (in thousands, except percentage) December 31, December 31, Federal tax benefit at statutory rate (21%) $ (6,302 ) $ (5,733 ) Stock-based compensation 1,143 1,049 State income tax benefit, net of federal tax effect (222 ) (269 ) Foreign tax differential (241 ) (237 ) Research credits 266 18 Other 3 3 Return to provision adjustment 335 (1,774 ) Change in valuation allowance 5,018 6,943 Income tax benefit $ - $ - |
Schedule of Principal Components of Deferred Tax Assets And Liabilities | The principal components of deferred tax assets and liabilities consist of the following at December 31, 2023 and 2022, respectively: (in thousands) December 31, December 31, Deferred tax assets Stock-based compensation $ 2,208 $ 1,386 Research and development 2,900 1,114 Federal NOL carryforwards 6,849 5,441 State NOL carryforwards 1,685 1,487 Foreign NOL carryforwards 5,965 4,307 Total deferred tax assets 19,607 13,735 Less valuation allowance (19,607 ) (13,735 ) Net deferred tax assets $ - $ - |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Payments to Leases | Future minimum payments pursuant to the leases (in thousands, except years) 2024 $ 186 2025 193 2026 198 2027 51 Total lease payments 628 Less: imputed interest (112 ) Present value of future lease payments 516 Less: operating lease, current liabilities (119 ) Long-term operating lease liabilities $ 397 |
Going Concern (Details)
Going Concern (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Going Concern [Abstract] | ||
Operating activities negative cash flows | $ 30,000 | $ 27,300 |
Cash, cash equivalents | 12,000 | 22,700 |
Accumulated deficit | $ (121,022) | $ (91,014) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Details) - shares | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Summary of Significant Accounting Policies [Line Items] | |||
Exercise of stock options | 5,496,000 | 4,841,417 | 4,097,000 |
Equity Option [Member] | |||
Summary of Significant Accounting Policies [Line Items] | |||
Exercise of stock options | 5,496,000 | 4,841,417 | |
Warrant [Member] | |||
Summary of Significant Accounting Policies [Line Items] | |||
Exercise of stock options | 45,386 | 74,074 |
Research and Development Acti_3
Research and Development Activity (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Jun. 26, 2025 | Jun. 26, 2024 | Jun. 26, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Research and Development Activity [Line Items] | |||||
Net sales percentage | 5% | ||||
Payable amount | $ 25,000 | ||||
Annual maintenance fees | $ 10,000 | ||||
Immune Ventures [Member] | |||||
Research and Development Activity [Line Items] | |||||
Percentage of licensor royalty patent grant | 1% | ||||
UK [Member] | |||||
Research and Development Activity [Line Items] | |||||
Research and development tax credit receivable | $ 0 | $ 2,690,000 | |||
UK [Member] | Research and Development Expense [Member] | |||||
Research and Development Activity [Line Items] | |||||
Reimbursements of research and development tax credit | 2,710,000 | 0 | |||
Australia [Member] | |||||
Research and Development Activity [Line Items] | |||||
Research and development tax credit receivable | 1,905,000 | 5,409,000 | |||
Australia [Member] | Research and Development Expense [Member] | |||||
Research and Development Activity [Line Items] | |||||
Reimbursements of research and development tax credit | $ 6,557,000 | $ 0 | |||
University of Pittsburg License Agreement [Member] | |||||
Research and Development Activity [Line Items] | |||||
Percentage of net sales to pay royalties | 2.50% | ||||
Agreement expiry period, description | The PITT Agreement expires upon the earlier of: (i) expiration of the last claim of the Patent Rights forming the subject matter of the PITT Agreement; or (ii) the date that is 20 years from the effective date of the agreement (June 26, 2037). | ||||
Forecast [Member] | |||||
Research and Development Activity [Line Items] | |||||
Annual maintenance fees | $ 25,000 | $ 10,000 |
Research and Development Acti_4
Research and Development Activity (Details) - Schedule of Milestone Payments in Consideration for the Patent Rights $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Each Phase I initiation [Member] | |
Revenue Recognition, Milestone Method [Line Items] | |
Payment method of milestone payments | $ 25 |
Each Phase II initiation [Member] | |
Revenue Recognition, Milestone Method [Line Items] | |
Payment method of milestone payments | 250 |
Each Phase III initiation [Member] | |
Revenue Recognition, Milestone Method [Line Items] | |
Payment method of milestone payments | 350 |
Each NDA/EMA filing [Member] | |
Revenue Recognition, Milestone Method [Line Items] | |
Payment method of milestone payments | 1,000 |
Each NDA/EMA awarded [Member] | |
Revenue Recognition, Milestone Method [Line Items] | |
Payment method of milestone payments | $ 9,000 |
Research and Development Acti_5
Research and Development Activity (Details) - Schedule of Licensee is Required to make Milestone Payments $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Each Phase I initiation [Member] | |
Research and Development Activity (Details) - Schedule of Licensee is Required to make Milestone Payments [Line Items] | |
Payment method of milestone payments | $ 50 |
Each Phase III initiation [Member] | |
Research and Development Activity (Details) - Schedule of Licensee is Required to make Milestone Payments [Line Items] | |
Payment method of milestone payments | 500 |
First commercial sale of product making use of licensed technology [Member] | |
Research and Development Activity (Details) - Schedule of Licensee is Required to make Milestone Payments [Line Items] | |
Payment method of milestone payments | $ 1,250 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Schedule of Hierarchy for Assets and Liabilities Measured at Fair Value - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Cash equivalents | ||
Money market funds | $ 35,162 | $ 51,058 |
Total cash equivalents | 35,162 | 51,058 |
Quoted Price in Active Market (Level 1) [Member] | Fair Value, Recurring [Member] | ||
Cash equivalents | ||
Money market funds | 35,162 | 51,058 |
Total cash equivalents | 35,162 | 51,058 |
Significant Other Observable Inputs (Level 2) [Member] | Fair Value, Recurring [Member] | ||
Cash equivalents | ||
Money market funds | ||
Total cash equivalents | ||
Significant Unobservable Inputs (Level 3) [Member] | Fair Value, Recurring [Member] | ||
Cash equivalents | ||
Money market funds | ||
Total cash equivalents |
Lease (Details) - Schedule of R
Lease (Details) - Schedule of Right-of-Use Assets and Liabilities - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Schedule of right-of-use assets and liabilities [Abstract] | ||
Right-of-use asset | $ 414 | $ 507 |
Operating lease, current liability | 119 | 87 |
Long-term operating lease liability | 397 | 526 |
Total lease liability | $ 516 | $ 613 |
Weighted-average remaining lease term | 3 years 3 months 18 days | 4 years 3 months 18 days |
Weighted-average discount rate | 12% | 12% |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
UCL [Member] | ||
Related Party Transactions [Line Items] | ||
Medical research expenses | $ 573,000 | $ 586,000 |
CTI [Member] | ||
Related Party Transactions [Line Items] | ||
Medical research expenses | 153,000 | |
Research and development | 5,000 | |
AmplifyBio [Member] | ||
Related Party Transactions [Line Items] | ||
Medical research expenses | $ 77,000 | $ 230,000 |
Debt (Details)
Debt (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Jun. 10, 2021 | |
Debt [Line Items] | |||
Term loan (in Dollars) | $ 5,000,000 | $ 15,000,000 | |
Interest expense (in Dollars) | $ 2,278,000 | $ 2,014,000 | |
Interest rate | 13% | ||
Percentage of premium | 1% | ||
The Wall Street Journal Plus [Member] | |||
Debt [Line Items] | |||
Redemption percentage | 6.50% | ||
The Wall Street Journal Plus [Member] | Minimum [Member] | |||
Debt [Line Items] | |||
Prime rate | 4.50% | ||
The Wall Street Journal Plus [Member] | Maximum [Member] | |||
Debt [Line Items] | |||
Prime rate | 7.75% |
Debt (Details) - Schedule of Te
Debt (Details) - Schedule of Term Loan and Debt Discount - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Schedule of Term Loan and Debt Discount [Abstract] | ||
Current portion of debt | $ 10,000 | |
Less: debt discount | (79) | |
Current portion of debt, net | $ 9,921 | $ 5,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||
Dec. 31, 2022 | Dec. 30, 2020 | Jul. 31, 2023 | Mar. 31, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Jun. 01, 2021 | Dec. 31, 2020 | |
Stockholders' Equity [Line Items] | ||||||||
Common stock, amount (in Dollars) | $ 45,000,000 | $ 28,700,000 | ||||||
Percentage of commission | 3% | |||||||
Number of common stock sold | 75,697 | |||||||
Sale of stock price per share (in Dollars per share) | $ 10.56 | |||||||
Aggregate net proceeds (in Dollars) | $ 775,000 | |||||||
Temporary equity share | 75,697 | |||||||
Temporary equity aggregate purchase price (in Dollars) | $ 799,000 | |||||||
Common stock shares reserved issuance | 1,952,525 | |||||||
Purchase shares | 665,000 | 819,000 | ||||||
Aggregated fair value of stock options (in Dollars) | $ 5,500,000 | $ 4,900,000 | $ 5,500,000 | |||||
Expected volatility rate | 91% | |||||||
Expected dividends (in Dollars) | $ 0 | 0 | ||||||
Recognized stock-based compensation expense (in Dollars) | 7,368,000 | $ 7,149,000 | ||||||
Unrecognized compensation cost related to non-vested stock options (in Dollars) | $ 8,592,000 | |||||||
Weighted-average period | 2 years 18 days | |||||||
Exercised warrants | ||||||||
Dividend of preferred share | 1 | |||||||
Preferred stock par value per share (in Dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Remaining shares of preferred stock | 9,955,000 | |||||||
Remaining preferred stock par value (in Dollars per share) | $ 0.001 | |||||||
Preferred stock, shares issued | 0 | 0 | 0 | |||||
Preferred stock, shares outstanding | 0 | 0 | 0 | |||||
2021 Incentive Stock Plan [Member] | ||||||||
Stockholders' Equity [Line Items] | ||||||||
Common stock shares reserved issuance | 4,000,000 | |||||||
2017 and 2019 Incentive Stock Plans [Member] | ||||||||
Stockholders' Equity [Line Items] | ||||||||
Purchase shares | 665,000 | |||||||
Minimum [Member] | ||||||||
Stockholders' Equity [Line Items] | ||||||||
Discount rate | 3.84% | 1.60% | ||||||
Expected life | 6 years | 6 years | ||||||
Expected volatility rate | 105% | |||||||
Maximum [Member] | ||||||||
Stockholders' Equity [Line Items] | ||||||||
Discount rate | 3.99% | 3.06% | ||||||
Expected life | 6 years 3 months | 10 years | ||||||
Expected volatility rate | 108% | |||||||
Series A Preferred Stock [Member] | ||||||||
Stockholders' Equity [Line Items] | ||||||||
Preferred stock par value per share (in Dollars per share) | $ 0.001 | $ 0.001 | ||||||
Exercise price (in Dollars per share) | $ 300 | |||||||
Designated shares preferred stock | 45,000 | |||||||
Director [Member] | ||||||||
Stockholders' Equity [Line Items] | ||||||||
Number of common stock sold | 82,900 | |||||||
Sale of stock price per share (in Dollars per share) | $ 8.43 | $ 8.43 | ||||||
Aggregate net proceeds (in Dollars) | $ 699,000 | |||||||
Warrants [Member] | ||||||||
Stockholders' Equity [Line Items] | ||||||||
Warrants term | 10 years | |||||||
Exercise price of per share (in Dollars per share) | $ 14.05 | |||||||
Warrants outstanding | 45,386 | 45,386 | ||||||
Intrinsic value of warrants (in Dollars) | $ 0 | |||||||
Exercised warrants | 28,688 | 19,792 | ||||||
Exchange shares of common stock | 4,781 | 19,792 | ||||||
Cash proceeds (in Dollars) | $ 30,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - Schedule of Stock Option Activity - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | |
Schedule of Stock Option Activity [Abstract] | ||||
Number of shares, Options granted (in Shares) | 665,000 | 819,000 | ||
Weighted- average Exercise Price, Options granted | $ 9.69 | $ 8.01 | ||
Weighted- average Remaining Contractual Term (years), Options granted | 10 years | 10 years | ||
Aggregate Intrinsic Value, Options granted | ||||
Number of shares, Exercisable, Ending balance (in Shares) | 4,319,605 | |||
Weighted- average Exercise Price, Exercisable, Ending balance | $ 8.16 | |||
Weighted- average Remaining Contractual Term (years), Exercisable, Ending balance | 5 years 8 months 1 day | |||
Aggregate Intrinsic Value, Exercisable, Ending balance (in Dollars) | $ 19,354 | |||
Number of shares, Options exercised (in Shares) | ||||
Weighted- average Exercise Price, Options exercised | ||||
Weighted- average Remaining Contractual Term (years), Options exercised | ||||
Aggregate Intrinsic Value, Options exercised (in Dollars) | ||||
Number of shares, Options cancelled (in Shares) | (10,417) | (74,583) | ||
Weighted- average Exercise Price, Options cancelled | $ 12.44 | $ 11.68 | ||
Weighted- average Remaining Contractual Term (years), Options cancelled | ||||
Aggregate Intrinsic Value, Options cancelled (in Dollars) | ||||
Number of shares, Outstanding, Balance (in Shares) | 4,841,417 | 4,097,000 | 5,496,000 | 4,841,417 |
Weighted- average Exercise Price, Outstanding, Balance | $ 8.6 | $ 8.67 | $ 8.73 | $ 8.6 |
Weighted- average Remaining Contractual Term (years), Balance | 7 years 2 months 15 days | 6 years 2 months 4 days | 6 years 3 months 10 days | |
Aggregate Intrinsic Value, Outstanding, Balance (in Dollars) | $ 21,509 |
Stockholders' Equity (Details_2
Stockholders' Equity (Details) - Schedule of Stock-Based Compensation Expense - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Stockholders' Equity (Details) - Schedule of Stock-Based Compensation Expense [Line Items] | ||
Stock-based compensation expense | $ 7,368,000 | $ 7,149,000 |
Research and development [Member] | ||
Stockholders' Equity (Details) - Schedule of Stock-Based Compensation Expense [Line Items] | ||
Stock-based compensation expense | 2,743,000 | 2,645,000 |
General and administrative [Member] | ||
Stockholders' Equity (Details) - Schedule of Stock-Based Compensation Expense [Line Items] | ||
Stock-based compensation expense | $ 4,625,000 | $ 4,504,000 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Operating loss carryforward | $ 32,600,000 | |
Gross deferred tax assets | $ 19,600,000 | $ 13,700,000 |
Valuation allowance | $ 5,872,000 | |
Percentage amount of tax benefit | 50% |
Income Taxes (Details) - Schedu
Income Taxes (Details) - Schedule of Provision for Income Taxes - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Schedule of provision for income taxes [Abstract] | ||
Current expense (benefit) | ||
Federal | ||
State | ||
Foreign | ||
Current income tax expense | ||
Deferred expense (benefit) | ||
Federal | ||
State | ||
Foreign | ||
Deferred income tax | ||
Net deferred taxes |
Income Taxes (Details) - Sche_2
Income Taxes (Details) - Schedule of Reconciliation of Income Tax Benefit Computed Using the Federal Statutory Income Tax Rate to the Company’s Tax Expense - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Schedule of reconciliation of income tax benefit computed using the federal statutory income tax rate to the company’s tax expense[Abstract] | ||
Federal tax benefit at statutory rate (21%) | $ (6,302) | $ (5,733) |
Stock-based compensation | 1,143 | 1,049 |
State income tax benefit, net of federal tax effect | (222) | (269) |
Foreign tax differential | (241) | (237) |
Research credits | 266 | 18 |
Other | 3 | 3 |
Return to provision adjustment | 335 | (1,774) |
Change in valuation allowance | 5,018 | 6,943 |
Income tax benefit |
Income Taxes (Details) - Sche_3
Income Taxes (Details) - Schedule of Principal Components of Deferred Tax Assets And Liabilities - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Schedule of principal components of deferred tax assets and liabilities[Abstract] | ||
Stock-based compensation | $ 2,208 | $ 1,386 |
Research and development | 2,900 | 1,114 |
Federal NOL carryforwards | 6,849 | 5,441 |
State NOL carryforwards | 1,685 | 1,487 |
Foreign NOL carryforwards | 5,965 | 4,307 |
Total deferred tax assets | 19,607 | 13,735 |
Less valuation allowance | (19,607) | (13,735) |
Net deferred tax assets |
Collaborative Agreements (Detai
Collaborative Agreements (Details) $ in Millions | Sep. 30, 2020 USD ($) |
Collaborative Agreements [Abstract] | |
Grants receivable amount | $ 2.9 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease expense | $ 163,000 | $ 209,000 |
Commitments and Contingencies_3
Commitments and Contingencies (Details) - Schedule of Future Minimum Payments to Leases - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Schedule of Future Minimum Payments to Leases [Abstract] | ||
2024 | $ 186 | |
2025 | 193 | |
2026 | 198 | |
2027 | 51 | |
Total lease payments | 628 | |
Less: imputed interest | (112) | |
Present value of future lease payments | 516 | $ 613 |
Less: operating lease, current liabilities | (119) | (87) |
Long-term operating lease liabilities | $ 397 | $ 526 |