Inmune Bio, Inc. 10-K

Item 8. Financial Statements and Supplementary Data INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Page AUDITED FINANCIAL STATEMENTS: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB ID Number 688 ) F-2 CONSOLIDATED BALANCE SHEETS AS OF DECEMBER 31, 2022 AND 2021 F-3 CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021 F-4 CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021 F-5 CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021 F-6 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS F-7 F- 1 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Stockholders and Board of Directors of INmune Bio, Inc. Boca Raton, Florida Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of INmune Bio, Inc. (the “Company”) as of December 31, 2022 and 2021, the related consolidated statements of operations and comprehensive loss, changes in stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2022, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America Basis for Opinion These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion. /s/ Marcum llp Marcum llp We have served as the Company’s auditor since 2017. Houston, Texas March 2, 2023 F- 2 INMUNE BIO INC. CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share amounts) December 31, 2022 December 31, 2021 ASSETS 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 LIABILITIES AND STOCKHOLDERS’ EQUITY 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 See accompanying notes to these consolidated financial statements. F- 3 INMUNE BIO INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021 ( In thousands, except share and per share amounts) 2022 2021 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 $ ( 1.52 ) $ ( 1.88 ) Weighted average number of common shares outstanding – basic and diluted 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 ) See accompanying notes to these consolidated financial statements. F- 4 INMUNE BIO INC. CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021 (In thousands, except share amounts) Common Stock Additional Paid-In Accumulated Other Comprehensive Accumulated Total Stockholders’ Shares Amount Capital Income (loss) Deficit Equity Balance as of January 1, 2021 13,481,283 $ 13 $ 72,105 $ 11 $ ( 33,375 ) $ 38,754 Issuance of common stock for cash, net 3,970,854 5 80,248 - - 80,253 Settlement of Xencor warrant for cash and common stock 192,533 - ( 15,000 ) - - ( 15,000 ) Warrants issued to lenders as debt inducement - - 619 - - 619 Exercise of warrants 15,633 - 18 - - 18 Exercise of stock options 183,000 - 1,135 - - 1,135 Stock-based compensation - - 4,796 - - 4,796 Loss on foreign currency translation - - - ( 10 ) - ( 10 ) Net loss - - - - ( 30,340 ) ( 30,340 ) Balance as of December 31, 2021 17,843,303 18 143,921 1 ( 63,715 ) 80,225 Issuance of common stock for cash 82,900 - 699 - - 699 Exercise of warrants for cash 19,792 - 30 - - 30 Stock-based compensation - - 7,149 - - 7,149 Loss on foreign currency translation - - - ( 700 ) - ( 700 ) Net loss - - - - ( 27,299 ) ( 27,299 ) Balance as of December 31, 2022 17,945,995 $ 18 $ 151,799 $ ( 699 ) $ ( 91,014 ) $ 60,104 See accompanying notes to these consolidated financial statements. F- 5 INMUNE BIO INC. CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021 (In thousands) 2022 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 See accompanying notes to these consolidated financial statements. F- 6 INMUNE BIO INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS NOTE 1 – ORGANIZATION AND BASIS OF PRESENTATION 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. NOTE 2 – LIQUIDITY 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. F- 7 NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES 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. F- 8 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. F- 9 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. F- 10 Subsequent Events The Company has evaluated all transactions through the financial statement issuance date for subsequent disclosure consideration. NOTE 4 – RESEARCH AND DEVELOPMENT ACTIVITY 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 has the license rights to pursue alternative applications of the technology as part of its future development plans. 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. F- 11 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”). F- 12 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. NOTE 5 – FAIR VALUE MEASUREMENTS The following table presents the hierarchy for assets and liabilities measured at fair value on a recurring basis: (in thousands) Total Quoted Price in Active Market (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) 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. F- 13 NOTE 6 – LEASE 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, 2022 December 31, 2021 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 % NOTE 7 – RELATED PARTY TRANSACTIONS 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. NOTE 8 – DEBT 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. F- 14 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. F- 15 NOTE 9 – STOCKHOLDERS’ EQUITY 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 the year ended December 31, 2021, 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. 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 Shares Weighted- average Exercise Price Weighted- average Remaining Contractual Term (years) Aggregate Intrinsic Value 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 F- 16 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 December 31, 2022 Year Ended December 31, 2021 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. F- 17 Preferred Stock In 2020, the Company designated 45,000 shares of its preferred stock with par value of $ 0.001 per share as Series A Junior Participating Preferred Stock. The remaining 9,955,000 shares of preferred stock with par value of $ 0.001 remain undesignated. None of the preferred shares were issued and outstanding at December 31, 2022 and 2021. NOTE 10 – INCOME TAXES The provision for income taxes consists of the following components: December 31, 2022 December 31, 2021 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, 2022 December 31, 2021 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 $ - $ - F- 18 The principal components of deferred tax assets and liabilities consist of the following at December 31, 2022 and 2021, respectively: (in thousands) December 31, 2022 December 31, 2021 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. NOTE 11 – COLLABORATIVE AGREEMENTS 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. F- 19 NOTE 12 – COMMITMENTS AND CONTINGENCIES 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. NOTE 13 – SUBSEQUENT EVENTS 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. F- 20 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None.