Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 02, 2023 | Jun. 30, 2022 | |
Document Information Line Items | |||
Entity Registrant Name | INMUNE BIO INC. | ||
Trading Symbol | INMB | ||
Document Type | 10-K | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Common Stock, Shares Outstanding | 17,945,995 | ||
Entity Public Float | $ 103 | ||
Amendment Flag | false | ||
Entity Central Index Key | 0001711754 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Well-known Seasoned Issuer | No | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Shell Company | false | ||
Entity Ex Transition Period | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity File Number | 001-38793 | ||
Entity Incorporation, State or Country Code | NV | ||
Entity Tax Identification Number | 47-5205835 | ||
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 | ||
City Area Code | (858) | ||
Local Phone Number | 964 3720 | ||
Title of 12(b) Security | Common Stock ($0.001 par value) | ||
Security Exchange Name | NASDAQ | ||
Entity Interactive Data Current | Yes | ||
Auditor Firm ID | 688 | ||
Auditor Name | Marcum llp | ||
Auditor Location | Houston, Texas |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
CURRENT ASSETS | ||
Cash and cash equivalents | $ 52,153 | $ 74,810 |
Research and development tax credit receivable | 8,099 | 4,913 |
Other tax receivable | 362 | 591 |
Prepaid expenses and other current assets | 4,027 | 2,278 |
Prepaid expenses – related party | 34 | 14 |
TOTAL CURRENT ASSETS | 64,675 | 82,606 |
Operating lease – right of use assets | 507 | 726 |
Other assets | 99 | 99 |
Acquired in-process research and development intangible assets | 16,514 | 16,514 |
TOTAL ASSETS | 81,795 | 99,945 |
CURRENT LIABILITIES | ||
Accounts payable and accrued liabilities | 5,206 | 3,733 |
Accounts payable and accrued liabilities – related parties | 9 | 80 |
Deferred liabilities | 616 | 474 |
Current portion of long-term debt | 5,000 | |
Operating lease, current liabilities | 87 | 72 |
TOTAL CURRENT LIABILITIES | 10,918 | 4,359 |
Long-term debt, less debt discount | 9,697 | 14,458 |
Long-term operating lease liabilities | 526 | 704 |
Accrued liability – long-term | 550 | 199 |
TOTAL LIABILITIES | 21,691 | 19,720 |
COMMITMENTS AND CONTINGENCIES | ||
STOCKHOLDERS’ EQUITY | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized, 0 shares issued and outstanding | ||
Common stock, $0.001 par value, 200,000,000 shares authorized, 17,945,995 and 17,843,303 shares issued and outstanding, respectively | 18 | 18 |
Additional paid-in capital | 151,799 | 143,921 |
Accumulated other comprehensive (loss) income | (699) | 1 |
Accumulated deficit | (91,014) | (63,715) |
TOTAL STOCKHOLDERS’ EQUITY | 60,104 | 80,225 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 81,795 | $ 99,945 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
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 | 17,945,995 | 17,843,303 |
Common stock, shares outstanding | 17,945,995 | 17,843,303 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Statement [Abstract] | ||
REVENUE | $ 374 | $ 181 |
OPERATING EXPENSES | ||
General and administrative | 9,258 | 8,791 |
Research and development | 17,067 | 20,543 |
Total operating expenses | 26,325 | 29,334 |
LOSS FROM OPERATIONS | (25,951) | (29,153) |
OTHER EXPENSE, NET | ||
Other expense, net | (1,348) | (1,187) |
Total other expense, net | (1,348) | (1,187) |
NET LOSS | $ (27,299) | $ (30,340) |
Net loss per common share – basic and diluted (in Dollars per share) | $ (1.52) | $ (1.88) |
Weighted average number of common shares outstanding – basic and diluted (in Shares) | 17,927,327 | 16,130,539 |
COMPREHENSIVE LOSS | ||
Net loss | $ (27,299) | $ (30,340) |
Other comprehensive loss – foreign currency translation | (700) | (10) |
Total comprehensive loss | $ (27,999) | $ (30,350) |
Consolidated Statements of Op_2
Consolidated Statements of Operations and Comprehensive Loss (Parentheticals) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Statement [Abstract] | ||
Net loss per common share – basic and diluted | $ (1.52) | $ (1.88) |
Weighted average common shares outstanding - basic and diluted | 17,927,327 | 16,130,539 |
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, 2020 | $ 13 | $ 72,105 | $ 11 | $ (33,375) | $ 38,754 |
Balance (in Shares) at Dec. 31, 2020 | 13,481,283 | ||||
Issuance of common stock for cash | $ 5 | 80,248 | 80,253 | ||
Issuance of common stock for cash (in Shares) | 3,970,854 | ||||
Settlement of Xencor warrant for cash and common stock | (15,000) | (15,000) | |||
Settlement of Xencor warrant for cash and common stock (in Shares) | 192,533 | ||||
Warrants issued to lenders as debt inducement | 619 | 619 | |||
Exercise of warrants | 18 | 18 | |||
Exercise of warrants (in Shares) | 15,633 | ||||
Exercise of stock options | 1,135 | 1,135 | |||
Exercise of stock options (in Shares) | 183,000 | ||||
Stock-based compensation | 4,796 | 4,796 | |||
Loss on foreign currency translation | (10) | (10) | |||
Net loss | (30,340) | (30,340) | |||
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 | 699 | 699 | |||
Issuance of common stock for cash (in Shares) | 82,900 | ||||
Exercise of warrants | 30 | 30 | |||
Exercise of warrants (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 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (27,299) | $ (30,340) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 7,149 | 4,796 |
Impairment of right of use asset | 89 | |
Accretion of debt discount | 239 | 126 |
Changes in operating assets and liabilities: | ||
Research and development tax credit receivable | (3,186) | (3,227) |
Other tax receivable | 229 | (478) |
Prepaid expenses and other current assets | (1,749) | (2,058) |
Prepaid expenses – related party | (20) | (14) |
Other assets | (99) | |
Accounts payable and accrued liabilities | 1,473 | 2,215 |
Accounts payable and accrued liabilities – related parties | (71) | 46 |
Deferred liabilities | 142 | 284 |
Accrued liability – long-term | 351 | 199 |
Operating lease liabilities | (33) | 46 |
Net cash used in operating activities | (22,686) | (28,504) |
CASH FROM INVESTING ACTIVITIES | ||
Cash paid to Xencor to settle warrant for acquired research and development intangible assets | (15,000) | |
Net cash used in investing activities | (15,000) | |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Net proceeds from the issuance of debt | 14,951 | |
Net proceeds from sale of common stock | 699 | 80,253 |
Net proceeds from the exercise of stock options | 1,135 | |
Net proceeds from the exercise of warrants | 30 | 18 |
Net cash provided by financing activities | 729 | 96,357 |
Impact on cash from foreign currency translation | (700) | (10) |
NET (DECREASE) INCREASE IN CASH | (22,657) | 52,843 |
CASH AT BEGINNING OF YEAR | 74,810 | 21,967 |
CASH AT END OF YEAR | 52,153 | 74,810 |
SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | ||
Cash paid for income taxes | ||
Cash paid for interest expense | 1,372 | 559 |
NONCASH INVESTING AND FINANCING ACTIVITIES: | ||
Common stock issued to Xencor to settle warrant issued for acquired research and development intangible assets | 3,300 | |
Warrants issued to lenders as debt inducement | $ 619 |
Organization and Basis of Prese
Organization and Basis of Presentation | 12 Months Ended |
Dec. 31, 2022 | |
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 for Duchenne’s Muscular Dystrophy (“DMD”). 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. |
Liquidity
Liquidity | 12 Months Ended |
Dec. 31, 2022 | |
Insurance Loss Reserves [Abstract] | |
LIQUIDITY | NOTE 2 As of December 31, 2022, the Company had an accumulated deficit of $91,014,000 and experienced losses since its inception. The Company had cash, cash equivalents of $52,153,000 as of December 31, 2022 and has not generated positive cash flows from operations. To date, the Company has funded its operations primarily through the sale of its common stock. Although it is difficult to predict the Company’s liquidity requirements, as of December 31, 2022, and based upon the Company’s current operating plan, the Company believes that it will have sufficient cash to meet its projected operating requirements for at least the next 12 months following the filing date of this Annual Report on Form 10-K based on the balance of cash available as of December 31, 2022. Management expects operating losses to continue for the foreseeable future. There can be no assurance that the Company will ever earn revenues or achieve profitability, or if achieved, that they will be sustained on a continuing basis. In addition, the manufacturing, clinical and preclinical development activities as well as the commercialization of the Company’s products, if approved, will require significant additional financing. The Company may be unable to secure such financing when needed, or if available, such financings may be under terms that are unfavorable to the Company or the current stockholders. If the Company is unable to raise additional funds when needed, it may be required to delay, reduce the scope of, or eliminate development programs, which may adversely affect its business and operations. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
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. Risks and Uncertainties The Company is subject to risks and uncertainties as a result of the COVID-19 pandemic. The extent of the impact of the COVID-19 pandemic on the Company’s business is highly uncertain and difficult to predict. Also, economies worldwide have also been negatively impacted by the COVID-19 pandemic, however policymakers around the globe have responded with fiscal policy actions to support the healthcare industry and economy as a whole. The magnitude and overall effectiveness of these actions remain uncertain. In addition, the Company’s clinical trials have been affected by and may continue to be affected by the COVID-19 pandemic. Clinical site initiation and patient enrollment have and may continue to be delayed due to prioritization of hospital resources toward the COVID-19 pandemic. Some patients have not, and others may not be able to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services. Similarly, the ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19, may adversely impact the Company’s clinical trial operations. The severity of the impact of the COVID-19 pandemic on the Company’s business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic and the extent and severity of the impact on the Company’s service providers, suppliers, contract research organizations (“CROs”) and the Company’s clinical trials, all of which are uncertain and cannot be predicted. As of the date of issuance of Company’s financial statements, the extent to which the COVID-19 pandemic may materially impact the Company’s financial condition, liquidity or results of operations is uncertain. 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, 2022 and 2021, 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, 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. At December 31, 2021, the Company had 4,097,000 potentially issuable shares of common stock upon the exercise of stock options and 93,866 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 2022 and 2021 revenue was from the sale of MSC’s to one and three customers, respectively, 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, costs of preclinical studies, clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, 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. Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments, as clarified in subsequent amendments. ASU 2016-13 changes the impairment model for certain financial instruments. The new model is a forward-looking expected loss model and will apply to financial assets subject to credit losses and measured at amortized cost and certain off-balance sheet credit exposures. This includes loans, held-to-maturity debt securities, loan commitments, financial guarantees and net investments in leases, as well as trade receivables. For available-for-sale debt securities with unrealized losses, credit losses will be measured in a manner similar to today, except that the losses will be recognized as allowances rather than reductions in the amortized cost of the securities. In October 2019, the FASB voted to delay the effective date of this standard. Topic 326 will be effective for the Company on January 1, 2023. The Company does not expect this standard to have a material effect on the Company’s financial statements. 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, 2022 | |
Research and Development [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, 2022 and 2021, the Company had a research and development tax credit receivable of $2,690,000 and $3,319,000, respectively for R&D expenses incurred in the UK. During the years ended December 31, 2022 and 2021, the Company received $0 and $814,000 of R&D tax credit reimbursements, respectively from the UK. During January 2023, the Company received $2,710,000 of R&D tax credit reimbursements 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, 2022 and 2021, the Company had a research and development tax credit receivable of $5,409,000 and $1,594,000, respectively, for R&D expenses incurred in Australia. During the years ended December 31, 2022 and 2021, the Company received $0 and $1,296,000 of R&D tax credit reimbursements, respectively from Australia. During February 2023, the Company received $3,763,000 of R&D tax credit reimbursements 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 has discovered and developed a proprietary biological molecule that inhibits soluble tumor necrosis factor. During June 2021, the Company entered into the First Amendment to License Agreement. Pursuant to the 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. In connection with the Xencor License Agreement, the Company paid Xencor a one-time non-creditable and non-refundable fee of $100,000 and issued Xencor 1,585,000 shares of the Company’s common stock with a fair value of $12,221,000. In addition, the Company issued Xencor fully vested warrants with a fair value of $4,193,000 to purchase an additional number of shares of common stock equal to 10% of the fully diluted company shares immediately following such purchase, which warrant has since been cancelled (see the description below). The aggregate purchase price for the full exercise of the warrant was $10,000,000. The Company recorded $16,514,000 for the acquisition of intangible assets for the in-process research and development as the fair value of the cash, stock and warrants on the date of the License Agreement acquisition in accordance with Accounting Standards Codification 730 – Research and Development 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. Under the Xencor License Agreement, the Company also agreed to pay Xencor a percentage of any sublicensing revenue that it receives. On June 10, 2021, the Company and Xencor entered into an Option Cancellation Agreement whereby Xencor terminated its warrant to purchase 10% of the fully diluted shares of the Company in exchange for a cash payment of $15,000,000 and 192,533 shares of the Company’s common stock with a fair value of $3,300,000 based on the market price of the common stock as of June 10, 2021, which the Company issued in June 2021. The Company filed a registration statement covering the resale of these shares during September 2021 and agreed to keep the registration statement continuously effective until all such shares cease to be outstanding or otherwise cease to be registrable securities as defined in the Option Cancellation Agreement. The Company charged the cash consideration paid to Xencor to enter into the Option Cancellation Agreement to equity as the fair value of the warrant immediately prior to the Option Cancellation Agreement was greater than the consideration paid to Xencor. 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 During July 2021, the Company initiated a Phase I clinical trial using INKmune and the Company paid Immune Ventures a $25,000 milestone payment. 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. As of December 31, 2022 and December 31, 2021, no sales had occurred under this license. The term of the agreement began on October 29, 2015 and, if not terminated sooner pursuant to the agreement, ends on a country-by-country basis on the date of the expiration of the last to expire patent rights where patent rights exists. 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, the parties amended the agreement under which the Company was required achieve milestones pursuant to the agreement. On October 30, 2020, the parties executed an additional amendment to the agreement under which the Company is required to achieve the following milestones: Initiation of Phase II clinical trials or equivalent by October 29, 2023 Initiation of Phase III clinical trials or equivalent by October 29, 2025 Filing of NDA or equivalent by October 29, 2026 or equivalent If the Company doesn’t achieve the above milestones, it is required to negotiate in good faith with Immune Ventures to determine how it can either remedy the failure or achieve an alternate development. If the Company fails to make any required efforts, or if the efforts do not remedy the situation within 60 days of written notice by Immune Ventures, then Immune Ventures may provide notice to terminate the license or convert it to a non-exclusive license. 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: $5,000 due June 26 of each year 2020-2022; $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, 2022. (in thousands) June 26 of each year 2020-2022 $ 5 June 26 of each year 2023-2024 $ 10 June 26 of each year 2025 until first commercial sale $ 25 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. There were no commercial sales of product making use of the licensed technology under the PITT Agreement in 2022. 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 Company made a $50,000 milestone payment in March 2019 pursuant to the PITT Agreement as a result of a Phase I initiation. 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, 2022 | |
Fair Value Disclosures [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, 2022: Cash equivalents Money market fund $ 51,058 $ 51,058 $ - $ - Total cash equivalents $ 51,058 $ 51,058 $ - $ - The Company had no assets and liabilities measured at fair value on a recurring basis as of December 31, 2021. |
Lease
Lease | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
LEASE | NOTE 6 In May 2019, the Company signed a sublease agreement with CTI Clinical Trial & Consulting Services (“CTI”) for office space in La Jolla, California. The lessor was CTI Clinical Trial & Consulting Services (“CTI”). CTI is majority-owned by a member of the Company’s Board of Directors. During 2022, the Company entered into a sublease termination agreement with CTI whereby the Company paid CTI $153,000 to terminate the sublease. During the year ended December 31, 2022, the Company recorded a right-of-use asset impairment of $89,000 within general and administrative expenses. 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 (La Jolla lease) $ - $ 118 Right-of-use asset (Boca Raton lease) 507 608 Total $ 507 $ 726 Operating lease, current liability (La Jolla lease) $ - $ 52 Operating lease, current liability (Boca Raton lease) 87 20 Total 87 72 Long-term operating lease liability (La Jolla lease) - 84 Long-term operating lease liability (Boca Raton lease) 526 620 526 704 Total lease liability $ 613 $ 776 Weighted-average remaining lease term 4.3 years 4.6 years Weighted-average discount rate 12.0 % 10.0 % |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2022 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | NOTE 7 UCL At December 31, 2022 and 2021, the Company owed UCL Consultants Limited (“UCL”) $0 and $10,000, respectively, in connection with medical research performed on behalf of the Company. During the years ended December 31, 2022 and 2021, the Company paid UCL $586,000 and $218,000, 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 the years ended December 31, 2022 and 2021, the Company paid CTI $153,000 and $38,000, respectively, pursuant to its sublease agreement with CTI. See Note 6. The Company also paid CTI $5,000 in 2022 for medical research performed on behalf of the Company. AmplifyBio During the years ended December 31, 2022 and 2021, the Company paid AmplifyBio $230,000 and $0, respectively, to perform certain medical research 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, 2022 | |
Debt Disclosure [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, 2022: (in thousands) Term Loan $ 15,000 Less: debt discount and financing costs, net (303 ) Less: current portion (5,000 ) Long-term debt $ 9,697 For the years ended December 31, 2022 and 2021, the Company recognized interest expense of $2,014,000 and $985,000, respectively, related to the Term Loan. The term loan repayment schedule provided for interest only payments beginning on July 1, 2021, and continuing for 12 months, followed by monthly principal and interest payments, starting on July 1, 2022 and continuing through the maturity date of January 1, 2025. During August 2021, the Lenders extended the interest-only period for one year due to the Company achieving an equity milestone as fully defined in the Term Loan. As a result of achieving the equity milestone, monthly principal and interest payments begin on July 1, 2023. All outstanding principal and accrued and unpaid interest will be due and payable on the maturity date. 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, 2022, the interest rate was 12.0%. 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 loans in full, subject to a prepayment premium of (i) 2% of the original principal amount borrowed for any prepayment after the first anniversary and on or before the second anniversary of the loan or (ii) 1% of the original principal amount borrowed for any prepayment after the second anniversary of the loan but before the maturity date. The expected repayment of the $15.0 million Term loan principal is as follows as of December 31, 2022: (in thousands, except years) 2022 $ - 2023 5,000 2024 10,000 Total debt 15,000 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. The Company violated certain non-financial debt covenants as of December 31, 2022 and received a waiver from the Lenders waiving these debt covenant violations. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
STOCKHOLDERS’ EQUITY | NOTE 9 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. Common Stock – At the Market Offerings During April 2020, the Company entered into a sales agreement with BTIG, LLC (“BTIG"), as sales agent, to establish an ATM offering to sell up to $10.0 million of the Company’s common stock (the “2020 ATM”). In August 2020, the sales agreement was amended whereby the aggregate offering was increased from $10.0 million to $30.0 million. During March 2021, the Company entered into a sales agreement with BTIG, as agent, to establish an At-The-Market (“ATM”) offering of up to $45 million of common stock (the “2021 ATM”), 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 the year ended December 31, 2021, the Company sold 713,192 shares of its common stock at an average price of $21.73 per share under the 2021 ATM agreement. The aggregate net proceeds were approximately $14.9 million after BTIG’s commission and other offering expenses. Registered Direct Offering During July 2021, the Company completed a registered direct offering whereby the Company sold 1,818,182 shares of its common stock to investors for gross proceeds of $38.0 million (net proceeds of $36.9 million). Issuance of shares to Xencor On June 10, 2021, the Company and Xencor entered into an Option Cancellation Agreement whereby the Company issued 192,533 shares of its common stock to Xencor (See Note 4). Stock options 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 years, (3) expected volatility of approximately 105% - 108% based on the trading history of similar companies, and (4) zero expected dividends. During 2021, the Company granted various employees, consultants and directors options to purchase 823,000 shares of common stock pursuant to the 2021, 2019 and 2017 Incentive Stock Plans. The stock options vest over zero to four years and had a fair value of $14,027,000 that was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 0.78-1.49%% based on the applicable US Treasury bill rate (2) expected life of 6.00-10.00 years, (3) expected volatility of approximately 105%-114% based on the trading history of similar companies, and (4) zero expected dividends. At December 31, 2022, the Company had 607,108 shares reserved for issuance, of which 591,132 shares were available for issuance pursuant to the 2021 Incentive Stock Plan, 7,313 shares were available for issuance pursuant to the 2019 Incentive Stock Plan, and 8,663 shares were available for issuance pursuant to the 2017 Stock Incentive Plan. The following table summarizes stock option activity: (in thousands, except share and per share amounts) Number of Weighted- Weighted- Aggregate Outstanding at January 1, 2021 3,457,000 $ 5.82 8.05 - Options granted 823,000 $ 20.63 10.0 - Options exercised (183,000 ) $ 6.21 - - Options cancelled - $ - - - 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 $ 4,155 Exercisable at December 31, 2022 3,601,817 $ 7.38 6.97 $ 4,108 During the years ended December 31, 2022 and 2021, the Company recognized stock-based compensation expense of $7,149,000 and $4,796,000, respectively, related to stock options. As of December 31, 2021, there was $11,198,000 of total unrecognized compensation cost related to non-vested stock options which is expected to be recognized over a weighted-average period of 2.23 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, 2022, 45,386 of these warrants are outstanding and the intrinsic value of these warrants is $0. The Company issued warrants to its placement agents in connection with its February 2019 initial public offering. The warrants are exercisable until December 19, 2023 and have an exercise price of $9.60. At December 31, 2022, 28,688 of these warrants are outstanding and the intrinsic value is $0. During the year ended December 31, 2022, a third party exercised 19,792 warrants which were issued in 2017 for cash proceeds of approximately $30,000. The Company issued 19,792 shares of its common stock in connection with the exercise of warrants. 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, 2022 and 2021 respectively: Year Ended Year Ended Research and development $ 2,645,000 $ 1,651,000 General and administrative 4,504,000 3,145,000 Total $ 7,149,000 $ 4,796,000 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 shall expire on December 30, 2023. 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 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
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 - - Foreign - - Current income tax expense - - Deferred expense (benefit) - - Federal - - 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%) $ (5,733 ) $ (6,381 ) Stock-based compensation 1,049 1,156 State income tax benefit, net of federal tax effect (269 ) (519 ) Foreign tax differential (237 ) (41 ) Research credits 18 2,372 Other 3 2 Return to provision adjustment (1,774 ) 166 Change in valuation allowance 6,943 3,245 Income tax benefit $ - $ - The principal components of deferred tax assets and liabilities consist of the following at December 31, 2022 and 2021, respectively: (in thousands) December 31, December 31, Deferred tax assets Stock-based compensation $ 1,386 $ 934 Research and development 1,114 - Federal NOL carryforwards 5,441 3,702 State NOL carryforwards 1,487 - Foreign NOL carryforwards 4,307 2,156 Total deferred tax assets 13,735 6,792 Less valuation allowance (13,735 ) (6,792 ) Net deferred tax assets $ - $ - At December 31, 2022, the Company had a federal net operating loss carryforward of approximately $25.9 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 $13.7 million and $6.8 million at December 31, 2022 and 2021, 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 $6,943,000 during the year ended December 31, 2022. 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, 2022, and 2021, 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, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
COLLABORATIVE AGREEMENTS | NOTE 11 During 2020, the Company was awarded a $500,000 grant from the Amyotrophic Lateral Sclerosis (“ALS”) Association to fund a study of the efficacy of XPro to reverse ALS in vitro and to fund a study of the efficacy of XPro to protect against ALS model phenotypes in vivo. All of the proceeds pursuant to the grant were received prior to 2022. The grant period for the study ended December 31, 2022 and the Company has recorded a payable of $18,000 to the ALS Association in accounts payable and accrued liabilities for amounts received but not spent as of December 31, 2022. 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, 2022, the Company has not received any proceeds pursuant to this grant. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
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) 2023 $ 166 2024 186 2025 193 2026 198 2027 51 Total lease payments 794 Less: imputed interest (181 ) Present value of future lease payments 613 Less: operating lease, current liabilities (87 ) Long-term operating lease liabilities $ 526 During the years ended December 31, 2022 and 2021, the Company recognized $209,000 and $102,000, 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. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 13 During February 2023, the Company issued 605,000 stock options with a 10-year life and an exercise price of $9.74 to certain employees and directors. The stock options had a fair value of approximately $4.5 million that was calculated using the Black-Scholes option-pricing model. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
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. |
Risks and Uncertainties | Risks and Uncertainties The Company is subject to risks and uncertainties as a result of the COVID-19 pandemic. The extent of the impact of the COVID-19 pandemic on the Company’s business is highly uncertain and difficult to predict. Also, economies worldwide have also been negatively impacted by the COVID-19 pandemic, however policymakers around the globe have responded with fiscal policy actions to support the healthcare industry and economy as a whole. The magnitude and overall effectiveness of these actions remain uncertain. In addition, the Company’s clinical trials have been affected by and may continue to be affected by the COVID-19 pandemic. Clinical site initiation and patient enrollment have and may continue to be delayed due to prioritization of hospital resources toward the COVID-19 pandemic. Some patients have not, and others may not be able to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services. Similarly, the ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19, may adversely impact the Company’s clinical trial operations. The severity of the impact of the COVID-19 pandemic on the Company’s business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic and the extent and severity of the impact on the Company’s service providers, suppliers, contract research organizations (“CROs”) and the Company’s clinical trials, all of which are uncertain and cannot be predicted. As of the date of issuance of Company’s financial statements, the extent to which the COVID-19 pandemic may materially impact the Company’s financial condition, liquidity or results of operations is uncertain. |
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, 2022 and 2021, 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, 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. At December 31, 2021, the Company had 4,097,000 potentially issuable shares of common stock upon the exercise of stock options and 93,866 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 2022 and 2021 revenue was from the sale of MSC’s to one and three customers, respectively, 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, costs of preclinical studies, clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, 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 | Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments, as clarified in subsequent amendments. ASU 2016-13 changes the impairment model for certain financial instruments. The new model is a forward-looking expected loss model and will apply to financial assets subject to credit losses and measured at amortized cost and certain off-balance sheet credit exposures. This includes loans, held-to-maturity debt securities, loan commitments, financial guarantees and net investments in leases, as well as trade receivables. For available-for-sale debt securities with unrealized losses, credit losses will be measured in a manner similar to today, except that the losses will be recognized as allowances rather than reductions in the amortized cost of the securities. In October 2019, the FASB voted to delay the effective date of this standard. Topic 326 will be effective for the Company on January 1, 2023. The Company does not expect this standard to have a material effect on the Company’s financial statements. |
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, 2022 | |
Research and Development [Abstract] | |
Schedule of milestone payments in consideration for the patent rights | 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 consideration of annual maintenance fees under the PITT agreement | June 26 of each year 2020-2022 $ 5 June 26 of each year 2023-2024 $ 10 June 26 of each year 2025 until first commercial sale $ 25 |
Schedule of licensee is required to make milestone payments | 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, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of hierarchy for assets and liabilities measured at fair value | (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, 2022 | |
Leases [Abstract] | |
Schedule of right-of-use assets and liabilities | (in thousands, except years and rate) December 31, December 31, Right-of-use asset (La Jolla lease) $ - $ 118 Right-of-use asset (Boca Raton lease) 507 608 Total $ 507 $ 726 Operating lease, current liability (La Jolla lease) $ - $ 52 Operating lease, current liability (Boca Raton lease) 87 20 Total 87 72 Long-term operating lease liability (La Jolla lease) - 84 Long-term operating lease liability (Boca Raton lease) 526 620 526 704 Total lease liability $ 613 $ 776 Weighted-average remaining lease term 4.3 years 4.6 years Weighted-average discount rate 12.0 % 10.0 % |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of term loan and debt discount | Term Loan $ 15,000 Less: debt discount and financing costs, net (303 ) Less: current portion (5,000 ) Long-term debt $ 9,697 |
Schedule of repayment term loan principal | 2022 $ - 2023 5,000 2024 10,000 Total debt 15,000 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
Schedule of stock option activity | (in thousands, except share and per share amounts) Number of Weighted- Weighted- Aggregate Outstanding at January 1, 2021 3,457,000 $ 5.82 8.05 - Options granted 823,000 $ 20.63 10.0 - Options exercised (183,000 ) $ 6.21 - - Options cancelled - $ - - - 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 $ 4,155 Exercisable at December 31, 2022 3,601,817 $ 7.38 6.97 $ 4,108 |
Schedule of stock-based compensation expense | Year Ended Year Ended Research and development $ 2,645,000 $ 1,651,000 General and administrative 4,504,000 3,145,000 Total $ 7,149,000 $ 4,796,000 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of provision for income taxes | December 31, December 31, Current expense (benefit) $ - $ - Federal - - Foreign - - Current income tax expense - - Deferred expense (benefit) - - Federal - - 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 | (in thousands, except percentage) December 31, December 31, Federal tax benefit at statutory rate (21%) $ (5,733 ) $ (6,381 ) Stock-based compensation 1,049 1,156 State income tax benefit, net of federal tax effect (269 ) (519 ) Foreign tax differential (237 ) (41 ) Research credits 18 2,372 Other 3 2 Return to provision adjustment (1,774 ) 166 Change in valuation allowance 6,943 3,245 Income tax benefit $ - $ - |
Schedule of principal components of deferred tax assets and liabilities | (in thousands) December 31, December 31, Deferred tax assets Stock-based compensation $ 1,386 $ 934 Research and development 1,114 - Federal NOL carryforwards 5,441 3,702 State NOL carryforwards 1,487 - Foreign NOL carryforwards 4,307 2,156 Total deferred tax assets 13,735 6,792 Less valuation allowance (13,735 ) (6,792 ) Net deferred tax assets $ - $ - |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of future minimum payments pursuant leases | 2023 $ 166 2024 186 2025 193 2026 198 2027 51 Total lease payments 794 Less: imputed interest (181 ) Present value of future lease payments 613 Less: operating lease, current liabilities (87 ) Long-term operating lease liabilities $ 526 |
Liquidity (Details)
Liquidity (Details) | Dec. 31, 2022 USD ($) |
Insurance Loss Reserves [Abstract] | |
Accumulated deficit | $ 91,014,000 |
Cash equivalents | $ 52,153,000 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Details) - shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Jun. 10, 2021 | |
Summary of Significant Accounting Policies (Details) [Line Items] | |||
Original maturity date | 3 months | ||
Shares of common stock | 4,841,417 | 4,097,000 | |
Exercise of stock | 74,074 | 192,533 | |
Common Stock [Member] | |||
Summary of Significant Accounting Policies (Details) [Line Items] | |||
Exercise of stock | 19,792 | 93,866 |
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 | Jun. 30, 2022 | Jun. 10, 2021 | Jun. 10, 2021 | Jun. 30, 2020 | Jan. 31, 2023 | Jul. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Research and Development Activity (Details) [Line Items] | |||||||||||
Common stock with fair value on discounted cash flow | $ 12,221,000 | ||||||||||
Cash payment | $ 4,193,000 | ||||||||||
Aggregate purchase price for exercise of warrant | 10,000,000 | ||||||||||
Intangible assets | $ 16,514,000 | ||||||||||
Net sales percentage | 5% | ||||||||||
Common stock equal to fully diluted shares to purchase with fair value | 10% | ||||||||||
Market price of common stock | $ 3,300,000 | $ 619,000 | |||||||||
Research and Development Expense (Excluding Acquired in Process Cost) | $ 25,000 | ||||||||||
Annual maintenance fees | $ 5,000 | $ 5,000 | |||||||||
Milestone payment | $ 50,000 | ||||||||||
Maximum [Member] | |||||||||||
Research and Development Activity (Details) [Line Items] | |||||||||||
Cash payment | 15,000,000 | 15,000,000 | |||||||||
Minimum [Member] | |||||||||||
Research and Development Activity (Details) [Line Items] | |||||||||||
Cash payment | $ 192,533 | $ 192,533 | |||||||||
Australia [Member] | |||||||||||
Research and Development Activity (Details) [Line Items] | |||||||||||
Reimbursements of research and development tax credit | 3,763,000 | ||||||||||
Australia [Member] | |||||||||||
Research and Development Activity (Details) [Line Items] | |||||||||||
Reimbursements of research and development tax credit | $ 0 | 1,296,000 | |||||||||
University of Pittsburg License Agreement [Member] | |||||||||||
Research and Development Activity (Details) [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). | ||||||||||
Research and Development Expense [Member] | UNITED KINGDOM [Member] | |||||||||||
Research and Development Activity (Details) [Line Items] | |||||||||||
Research and development tax credit receivable | $ 2,690,000 | 3,319,000 | |||||||||
Reimbursements of research and development tax credit | 0 | 814,000 | |||||||||
Research and Development Expense [Member] | Australia [Member] | |||||||||||
Research and Development Activity (Details) [Line Items] | |||||||||||
Research and development tax credit receivable | $ 5,409,000 | $ 1,594,000 | |||||||||
Xencor, Inc. License Agreement [Member] | |||||||||||
Research and Development Activity (Details) [Line Items] | |||||||||||
Non-creditable and non-refundable fee | $ 100,000 | ||||||||||
Shares issued (in Shares) | 1,585,000 | ||||||||||
Intangible assets | 10% | ||||||||||
Immune Ventures [Member] | |||||||||||
Research and Development Activity (Details) [Line Items] | |||||||||||
Percentage of licensor royalty patent grant | 1% | ||||||||||
Subsequent Event [Member] | |||||||||||
Research and Development Activity (Details) [Line Items] | |||||||||||
Tax credit reimbursements | $ 2,710,000 | ||||||||||
Forecast [Member] | |||||||||||
Research and Development Activity (Details) [Line Items] | |||||||||||
Annual maintenance fees | $ 25,000 | $ 10,000 | $ 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, 2022 USD ($) | |
Each Phase I initiation [Member] | |
Research and Development Activity (Details) - Schedule of milestone payments in consideration for the patent rights [Line Items] | |
Payment method of milestone payments | $ 25 |
Each Phase II initiation [Member] | |
Research and Development Activity (Details) - Schedule of milestone payments in consideration for the patent rights [Line Items] | |
Payment method of milestone payments | 250 |
Each Phase III initiation [Member] | |
Research and Development Activity (Details) - Schedule of milestone payments in consideration for the patent rights [Line Items] | |
Payment method of milestone payments | 350 |
Each NDA/EMA filing [Member] | |
Research and Development Activity (Details) - Schedule of milestone payments in consideration for the patent rights [Line Items] | |
Payment method of milestone payments | 1,000 |
Each NDA/EMA awarded [Member] | |
Research and Development Activity (Details) - Schedule of milestone payments in consideration for the patent rights [Line Items] | |
Payment method of milestone payments | $ 9,000 |
Research and Development Acti_5
Research and Development Activity (Details) - Schedule of consideration of annual maintenance fees under the PITT agreement $ in Thousands | Dec. 31, 2022 USD ($) |
June 26 of each year 2020-2022 [Member] | |
Research and Development Activity (Details) - Schedule of consideration of annual maintenance fees under the PITT agreement [Line Items] | |
Annual maintenance fees until first commercial sale | $ 5 |
June 26 of each year 2023-2024 [Member] | |
Research and Development Activity (Details) - Schedule of consideration of annual maintenance fees under the PITT agreement [Line Items] | |
Annual maintenance fees until first commercial sale | 10 |
June 26 of each year 2025 until first commercial sale [Member] | |
Research and Development Activity (Details) - Schedule of consideration of annual maintenance fees under the PITT agreement [Line Items] | |
Annual maintenance fees until first commercial sale | $ 25 |
Research and Development Acti_6
Research and Development Activity (Details) - Schedule of licensee is required to make milestone payments $ in Thousands | 12 Months Ended |
Dec. 31, 2022 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 $ in Thousands | Dec. 31, 2022 USD ($) |
Cash equivalents | |
Money market fund | $ 51,058 |
Total cash equivalents | 51,058 |
Quoted Price in Active Market (Level 1) [Member] | |
Cash equivalents | |
Money market fund | 51,058 |
Total cash equivalents | 51,058 |
Significant Other Observable Inputs (Level 2) [Member] | |
Cash equivalents | |
Money market fund | |
Total cash equivalents | |
Significant Unobservable Inputs (Level 3) [Member] | |
Cash equivalents | |
Money market fund | |
Total cash equivalents |
Lease (Details)
Lease (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Sep. 30, 2021 | |
Leases (Details) [Line Items] | ||
Sublease termination agreement amount | $ 153,000 | |
Lease term | 64 months | |
La Jolla lease [Member] | ||
Leases (Details) [Line Items] | ||
General and administrative expenses | $ 89,000 |
Lease (Details) - Schedule of r
Lease (Details) - Schedule of right-of-use assets and liabilities - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Lease (Details) - Schedule of right-of-use assets and liabilities [Line Items] | ||
Right-of-use asset | $ 507 | $ 726 |
Operating lease, current liability | 87 | 72 |
Long-term operating lease liability | 526 | 704 |
Total lease liability | $ 613 | $ 776 |
Weighted-average remaining lease term | 4 years 3 months 18 days | 4 years 7 months 6 days |
Weighted-average discount rate | 12% | 10% |
La Jolla lease [Member] | ||
Lease (Details) - Schedule of right-of-use assets and liabilities [Line Items] | ||
Right-of-use asset | $ 118 | |
Operating lease, current liability | 52 | |
Long-term operating lease liability | 84 | |
Boca Raton lease [Member] | ||
Lease (Details) - Schedule of right-of-use assets and liabilities [Line Items] | ||
Right-of-use asset | 507 | 608 |
Operating lease, current liability | 87 | 20 |
Long-term operating lease liability | $ 526 | $ 620 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
UCL Consultants Limited [Member] | ||
Related Party Transactions (Details) [Line Items] | ||
Amount owed | $ 0 | $ 10,000 |
Payment for medical research performed expense | 586,000 | 218,000 |
CTI [Member] | ||
Related Party Transactions (Details) [Line Items] | ||
Amount owed | 5,000 | |
Prepaid expenses-related party | 153,000 | 38,000 |
Pre-clinical research performed expense | $ 230,000 | $ 0 |
Debt (Details)
Debt (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Jun. 10, 2021 | |
Debt (Details) [Line Items] | |||
Term loan from lenders (in Dollars) | $ 15,000,000 | ||
Term loan additional from lenders (in Dollars) | $ 5,000,000 | ||
Recognized interest expense (in Dollars) | $ 2,014,000 | $ 985,000 | |
Description of loan repayment in terms | The term loan repayment schedule provided for interest only payments beginning on July 1, 2021, and continuing for 12 months, followed by monthly principal and interest payments, starting on July 1, 2022 and continuing through the maturity date of January 1, 2025. | ||
Interest rate | 12% | ||
Original principal amount borrowed for prepayment percentage before second loan | 2% | ||
Original principal amount borrowed for prepayment percentage before maturity date | 1% | ||
Term loan repayment (in Dollars) | $ 15,000,000 | ||
The Wall Street Journal Plus [Member] | |||
Debt (Details) [Line Items] | |||
Prime rate, percentage | 4.50% | ||
Interest rate | 7.75% | ||
Amount borrowed, percentage | 6.50% |
Debt (Details) - Schedule of te
Debt (Details) - Schedule of term loan and debt discount $ in Thousands | Dec. 31, 2022 USD ($) |
Schedule Of Term Loan And Debt Discount Abstract | |
Term Loan | $ 15,000 |
Less: debt discount and financing costs, net | (303) |
Less: current portion | (5,000) |
Long-term debt | $ 9,697 |
Debt (Details) - Schedule of re
Debt (Details) - Schedule of repayment term loan principal $ in Thousands | Dec. 31, 2022 USD ($) |
Schedule Of Repayment Term Loan Principal Abstract | |
2022 | |
2023 | 5,000 |
2024 | 10,000 |
Total debt | $ 15,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||||||
Jul. 01, 2021 | Mar. 31, 2021 | Dec. 30, 2020 | Apr. 30, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Jun. 10, 2021 | Dec. 31, 2020 | Aug. 31, 2020 | |
Stockholders' Equity (Details) [Line Items] | |||||||||
Shares common stock (in Shares) | 1,818,182 | ||||||||
Per share price (in Dollars per share) | $ 8.43 | ||||||||
Gross proceeds | $ 38,000,000 | $ 699,000 | |||||||
Common stock value | $ 45,000,000 | $ 10,000,000 | |||||||
Net proceeds | $ 36,900,000 | ||||||||
Shares issued (in Shares) | 74,074 | 192,533 | |||||||
Purchase of shares (in Shares) | 823,000 | ||||||||
Aggregated fair value of stock options | $ 5,500,000 | ||||||||
Expected dividends | 0% | 0% | |||||||
Fair value | $ 14,027,000 | ||||||||
Shares for issuance (in Shares) | 607,108 | ||||||||
Stock-based compensation expense | $ 7,149,000 | 4,796,000 | |||||||
Unrecognized compensation cost | 11,198,000 | ||||||||
Weighted-average period | 2 years 2 months 23 days | ||||||||
Warrants term | 10 years | ||||||||
Exercise price (in Dollars per share) | $ 9.6 | ||||||||
Intrinsic value of warrants | $ 0 | ||||||||
Shareholder rights agreement, description | 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. | ||||||||
Shares of preferred stock | |||||||||
Preferred stock par value (in Dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | ||||||
Preferred stock, shares issued (in Shares) | 0 | 0 | |||||||
Preferred stock shares outstanding (in Shares) | 0 | 0 | |||||||
2021 Incentive Stock Plan [Member] | |||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||
Shares for issuance (in Shares) | 591,132 | ||||||||
2019 Incentive Stock Plan [Member] | |||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||
Shares for issuance (in Shares) | 7,313 | ||||||||
2017 Stock Incentive Plan [Member] | |||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||
Shares for issuance (in Shares) | 8,663 | ||||||||
Common Stock [Member] | |||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||
Shares common stock (in Shares) | 82,900 | ||||||||
Shares issued (in Shares) | 19,792 | 93,866 | |||||||
Warrant [Member] | |||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||
Exercise price (in Dollars per share) | $ 14.05 | ||||||||
Warrants outstanding | $ 45,386 | ||||||||
Intrinsic value of warrants | $ 0 | ||||||||
Warrants are outstanding (in Shares) | 28,688 | ||||||||
Warrants exercised (in Shares) | 19,792 | ||||||||
Cash proceeds | $ 30,000 | ||||||||
Preferred Stock [Member] | |||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||
Shares of preferred stock | $ 9,955,000 | ||||||||
Preferred stock, shares issued (in Shares) | |||||||||
Preferred stock shares outstanding (in Shares) | |||||||||
Minimum [Member] | |||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||
Aggregate offering amount | $ 10,000,000 | ||||||||
Discount rate | 1.60% | 0.78% | |||||||
Expected life | 6 years | 6 years | |||||||
Expected volatility rate | 105% | 105% | |||||||
Stock options vest | 0 days | ||||||||
Maximum [Member] | |||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||
Aggregate offering amount | $ 30,000,000 | ||||||||
Discount rate | 3.06% | 1.49% | |||||||
Expected life | 10 years | 10 years | |||||||
Expected volatility rate | 108% | 114% | |||||||
Stock options vest | 4 years | ||||||||
Series A Preferred Stock [Member] | |||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||
Shares of preferred stock | $ 45,000 | ||||||||
Preferred stock par value (in Dollars per share) | $ 0.001 | ||||||||
2020 ATM program [Member] | |||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||
Common stock at market offering, description | the Company sold 1,439,480 shares of its common stock at an average price of $20.17 per share under the 2020 ATM agreement. The aggregate net proceeds were approximately $28.4 million after BTIG’s commission and other offering expenses. | ||||||||
2021 ATM program [Member] | |||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||
Common stock at market offering, description | the Company sold 713,192 shares of its common stock at an average price of $21.73 per share under the 2021 ATM agreement. The aggregate net proceeds were approximately $14.9 million after BTIG’s commission and other offering expenses. | ||||||||
Employees and Directors [Member] | |||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||
Purchase of shares (in Shares) | 819,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - Schedule of stock option activity - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule Of Stock Option Activity Abstract | ||
Number of shares, Outstanding, Beginning balance | 4,097,000 | 3,457,000 |
Weighted- average Exercise Price, Outstanding, Beginning balance | $ 8.67 | $ 5.82 |
Weighted-average Remaining Contractual Term (years), Outstanding, Beginning balance | 8 years 18 days | |
Aggregate Intrinsic Value, Outstanding,Beginning balance | ||
Number of shares, Options granted | 819,000 | 823,000 |
Weighted- average Exercise Price, Options granted | $ 8.01 | $ 20.63 |
Weighted- average Remaining Contractual Term (years), Options granted | 10 years | 10 years |
Aggregate Intrinsic Value, Options granted | ||
Number of shares, Options exercised | (183,000) | |
Weighted- average Exercise Price, Options exercised | $ 6.21 | |
Weighted- average Remaining Contractual Term (years), Options exercised | ||
Aggregate Intrinsic Value, Options exercised | ||
Number of shares, Options cancelled | (74,583) | |
Weighted- average Exercise Price, Options cancelled | $ 11.68 | |
Weighted- average Remaining Contractual Term (years), Options cancelled | ||
Aggregate Intrinsic Value, Options cancelled | ||
Number of shares, Outstanding, Ending balance | 4,841,417 | 4,097,000 |
Weighted- average Exercise Price, Outstanding, Ending balance | $ 8.6 | $ 8.67 |
Weighted-average Remaining Contractual Term (years), Outstanding, Ending balance | 6 years 3 months 10 days | 7 years 2 months 15 days |
Aggregate Intrinsic Value, Outstanding, Ending balance | $ 4,155 | |
Number of shares, Exercisable | 3,601,817 | |
Weighted- average Exercise Price, Exercisable | $ 7.38 | |
Weighted-average Remaining Contractual Term (years), Exercisable | 6 years 11 months 19 days | |
Aggregate Intrinsic Value, Exercisable | $ 4,108 |
Stockholders' Equity (Details_2
Stockholders' Equity (Details) - Schedule of stock-based compensation expense - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total | $ 7,149,000 | $ 4,796,000 |
Research and development [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total | 2,645,000 | 1,651,000 |
General and administrative [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total | $ 4,504,000 | $ 3,145,000 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Federal net operating loss carryforward | $ 25,900,000 | |
Gross deferred tax assets | 13,735,000 | $ 6,792,000 |
Valuation allowance | $ 6,943,000 | |
Percentage amount of tax benefit | 50% |
Income Taxes (Details) - Schedu
Income Taxes (Details) - Schedule of provision for income taxes - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule Of Provision For Income Taxes Abstract | ||
Federal | ||
Foreign | ||
Current income tax expense | ||
Foreign | ||
Deferred income tax | ||
Net deferred taxes |
Income Taxes (Details) - Sche_2
Income Taxes (Details) - Schedule of reconciliation of income tax benefit computed using the federal statutory income tax rate to the company’s tax expense - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule Of Reconciliation Of Income Tax Benefit Computed Using The Federal Statutory Income Tax Rate To The Company STax Expense Abstract | ||
Federal tax benefit at statutory rate (21%) | $ (5,733) | $ (6,381) |
Stock-based compensation | 1,049 | 1,156 |
State income tax benefit, net of federal tax effect | (269) | (519) |
Foreign tax differential | (237) | (41) |
Research credits | 18 | 2,372 |
Other | 3 | 2 |
Return to provision adjustment | (1,774) | 166 |
Change in valuation allowance | 6,943 | 3,245 |
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, 2022 | Dec. 31, 2021 |
Schedule Of Principal Components Of Deferred Tax Assets And Liabilities Abstract | ||
Stock-based compensation | $ 1,386 | $ 934 |
Research and development | 1,114 | |
Federal NOL carryforwards | 5,441 | 3,702 |
State NOL carryforwards | 1,487 | |
Foreign NOL carryforwards | 4,307 | 2,156 |
Total deferred tax assets | 13,735 | 6,792 |
Less valuation allowance | (13,735) | (6,792) |
Net deferred tax assets |
Collaborative Agreements (Detai
Collaborative Agreements (Details) - USD ($) | 1 Months Ended | ||
Dec. 31, 2020 | Sep. 30, 2020 | Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Grand award, description | the Company was awarded a $500,000 grant from the Amyotrophic Lateral Sclerosis (“ALS”) Association to fund a study of the efficacy of XPro to reverse ALS in vitro and to fund a study of the efficacy of XPro to protect against ALS model phenotypes in vivo. | 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, 2022, the Company has not received any proceeds pursuant to this grant. | |
Grants received | $ 500,000 | ||
Grants recorded approximately | $ 18,000 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease expense | $ 209,000 | $ 102,000 |
Commitments and Contingencies_3
Commitments and Contingencies (Details) - Schedule of future minimum payments pursuant leases - Commitments [Member] $ in Thousands | Dec. 31, 2022 USD ($) |
Commitments and Contingencies (Details) - Schedule of future minimum payments pursuant leases [Line Items] | |
2023 | $ 166 |
2024 | 186 |
2025 | 193 |
2026 | 198 |
2027 | 51 |
Total lease payments | 794 |
Less: imputed interest | (181) |
Present value of future lease payments | 613 |
Less: operating lease, current liabilities | (87) |
Long-term operating lease liabilities | $ 526 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event [Member] $ / shares in Units, $ in Millions | 1 Months Ended |
Feb. 28, 2023 USD ($) $ / shares shares | |
Subsequent Events (Details) [Line Items] | |
Stock options shares issued | shares | 605,000 |
Stock options shares maturity term | 10 years |
Exercise price per share | $ / shares | $ 9.74 |
Stock options fair value amount | $ | $ 4.5 |