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 F-1 CONSOLIDATED BALANCE SHEETS AS OF DECEMBER 31, 2020 AND 2019 F-2 CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE YEARS ENDED DECEMBER 31, 2020 AND 2019 F-3 CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY FOR THE YEARS ENDED DECEMBER 31, 2020 AND 2019 F-4 CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED DECEMBER 31, 2020 AND 2019 F-5 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS F-6 76 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Stockholders and the Board of Directors of INmune Bio, Inc. La Jolla, California Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of INmune Bio, Inc. (the “Company”) as of December 31, 2020 and 2019, the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for the years ended December 31, 2020 and 2019, 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, 2020 and 2019, and the results of its operations and its cash flows for the years ended December 31, 2020 and 2019, 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 4, 2021 F- 1 INMUNE BIO, INC. CONSOLIDATED BALANCE SHEETS December 31, 2020 December 31, 2019 ASSETS CURRENT ASSETS Cash $ 21,966,883 $ 6,995,525 Research and development tax credit receivable 1,686,065 568,139 Other tax receivable 112,684 77,225 Prepaid expenses 220,090 97,623 Prepaid expenses – related party - 26,266 TOTAL CURRENT ASSETS 23,985,722 7,764,778 Operating lease – right of use asset – related party 156,214 191,543 Acquired in-process research and development intangible assets 16,514,000 16,514,000 TOTAL ASSETS $ 40,655,936 $ 24,470,321 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES Accounts payable and accrued liabilities $ 1,518,113 $ 401,989 Accounts payable and accrued liabilities – related parties 33,664 290,102 Deferred liabilities 190,612 - Operating lease, current liability – related party 33,873 8,288 TOTAL CURRENT LIABILITIES 1,776,262 700,379 Long-term operating lease liability – related party 126,286 160,164 TOTAL LIABILITIES 1,902,548 860,543 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, 13,481,283 and 10,770,948 shares issued and outstanding, respectively 13,481 10,771 Additional paid-in capital 72,104,539 44,833,703 Common stock issuable - 50,000 Accumulated other comprehensive income (loss) 10,708 (8,515 ) Accumulated deficit (33,375,340 ) (21,276,181 ) TOTAL STOCKHOLDERS’ EQUITY 38,753,388 23,609,778 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 40,655,936 $ 24,470,321 See accompanying notes to these consolidated financial statements. F- 2 INMUNE BIO, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE YEARS ENDED DECEMBER 31, 2020 AND 2019 2020 2019 REVENUE $ 10,916 $ - OPERATING EXPENSES General and administrative 6,321,097 6,016,056 Research and development 5,917,495 3,281,945 Gain on waiver of common stock issuable - (1,542,000 ) Total operating expenses 12,238,592 7,756,001 LOSS FROM OPERATIONS (12,227,676 ) (7,756,001 ) OTHER INCOME Other income 128,517 77,688 Total other income 128,517 77,688 NET LOSS $ (12,099,159 ) $ (7,678,313 ) Net loss per common share – basic and diluted $ (1.01 ) $ (0.75 ) Weighted average number of common shares outstanding – basic and diluted 11,988,492 10,272,641 COMPREHENSIVE LOSS Net loss $ (12,099,159 ) $ (7,678,313 ) Other comprehensive (income) loss – foreign currency translation 19,223 (15,044 ) Total comprehensive loss $ (12,079,936 ) $ (7,693,357 ) See accompanying notes to these consolidated financial statements. F- 3 INMUNE BIO, INC. CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY FOR THE YEARS ENDED DECEMBER 31, 2020 AND 2019 Accumulated Additional Common Other Total Common Stock Paid-In Stock Comprehensive Accumulated Stockholders’ Shares Amount Capital Issuable Income (loss) Deficit Equity Balance as of January 1, 2019 8,719,441 $ 8,719 $ 25,446,196 $ 4,676,000 $ 6,529 $ (13,597,868 ) $ 16,539,576 Issuance of common stock and warrants for cash, net 1,643,032 1,643 12,207,378 - - - 12,209,021 Issuance of common stock issuable 400,000 400 3,083,600 (3,084,000 ) - - - Waiver of common stock issuable - - - (1,542,000 ) - - (1,542,000 ) Stock-based compensation 8,475 9 4,096,529 - - - 4,096,538 Loss on foreign currency translation - - - - (15,044 ) - (15,044 ) Net loss - - - - - (7,678,313 ) (7,678,313 ) Balance as of December 31, 2019 10,770,948 10,771 44,833,703 50,000 (8,515 ) (21,276,181 ) 23,609,778 Issuance of common stock for cash, net 2,874,600 2,875 24,904,906 - - - 24,907,781 Acquisition and retirement of common stock (220,000 ) (220 ) (1,011,780 ) - - - (1,012,000 ) Capital contribution - - 215,761 - - - 215,761 Cashless exercise of warrants 2,400 2 (2 ) - - - - Issuance of common stock issuable 33,335 33 49,967 (50,000 ) - - - Stock-based compensation 20,000 20 3,111,984 - - - 3,112,004 Gain on foreign currency translation - - - - 19,223 - 19,223 Net loss - - - - - (12,099,159 ) (12,099,159 ) Balance as of December 31, 2020 13,481,283 $ 13,481 $ 72,104,539 $ - $ 10,708 $ (33,375,340 ) $ 38,753,388 See accompanying notes to these consolidated financial statements. F- 4 INMUNE BIO, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED DECEMBER 31, 2020 AND 2019 2020 2019 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $ (12,099,159 ) $ (7,678,313 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 3,112,004 4,096,538 Gain on waiver of common stock issuable - (1,542,000 ) Changes in operating assets and liabilities: Research and development tax credit receivable (1,117,926 ) 24,076 Other tax receivable (35,459 ) (39,843 ) Joint development cost receivable - 17,989 Prepaid expenses (122,467 ) (82,071 ) Prepaid expenses – related party 26,266 (26,266 ) Accounts payable and accrued liabilities 1,116,124 (151,232 ) Accounts payable and accrued liabilities – related parties (40,677 ) 19,557 Deferred liabilities 190,612 - Operating lease liability – related party 27,036 (23,091 ) Net cash used in operating activities (8,943,646 ) (5,384,656 ) CASH FLOWS FROM FINANCING ACTIVITIES: Net proceeds from sale of common stock 24,907,781 12,209,021 Purchase of common stock (1,012,000 ) - Net cash provided by financing activities 23,895,781 12,209,021 Impact on cash from foreign currency translation 19,223 (15,044 ) NET INCREASE IN CASH 14,971,358 6,809,321 CASH AT BEGINNING OF YEAR 6,995,525 186,204 CASH AT END OF YEAR $ 21,966,883 $ 6,995,525 SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: Cash paid for income taxes $ - $ - Cash paid for interest expense $ - $ - NONCASH INVESTING AND FINANCING ACTIVITIES: Capital contribution $ 215,761 $ - Cashless exercise of warrants $ 2 $ - Issuance of common stock issuable $ 50,000 $ 3,084,000 Issuance of warrants to placement agents $ - $ 247,452 See accompanying notes to these consolidated financial statements. F- 5 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 COVID-19 complications (Quellor), cancer (INB03), Alzheimer’s and treatment resistant depression (XPro595), and NASH (LIVNate). 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, 2020, the Company had an accumulated deficit of $33,375,340 and experienced losses since its inception. Losses have principally occurred as a result of non-cash stock-based compensation expense and the substantial resources required for research and development of the Company’s products, which included the general and administrative expenses associated with its organization and product development as well as the lack of sources of revenues until such time as the Company’s products are commercialized. To meet its current and future obligations the Company has taken the following steps to capitalize the business and achieve its business plan: ● During July 2020, the Company completed an underwritten public offering in which it sold 2,500,000 shares of common stock at a public offering price of $10.00 per share. The 2,500,000 shares sold included the full exercise of the underwriters’ option to purchase 326,086 shares at a price of $10.00 per share. Aggregate net proceeds from the underwritten public offering were approximately $23.1 million, net of approximately $1.9 million in underwriting discounts and commissions and offering expenses. ● During April 2020, the Company entered into a sales agreement with BTIG, LLC (“BTIG”), as sales agent, to establish an At-The-Market (“ATM”) offering program. The Company was required to pay BTIG a commission of 3% of the gross proceeds from the sale of shares. The ATM program will remain in full force and effect until the earlier of the sale of all of the shares under the ATM program or the termination of the sales agreement by the Company or BTIG. From April 2020 through December 2020, the Company sold 178,600 shares of common stock at an average price of $5.45 per share for net proceeds of approximately $0.8 million. During January and February 2021, the Company sold in aggregate 1,439,480 shares on common stock at an average price of $20.17 per share for net proceeds of approximately $28.4 million. F- 6 ● During May 2019, the Company entered into a securities purchase agreement (“Purchase Agreement”) with Lincoln Park Capital Fund LLC (“Lincoln Park”), pursuant to which Lincoln Park has agreed to purchase from the Company up to an aggregate of $20.0 million of common stock of the Company (subject to certain limitations) from time to time over the term of the Purchase Agreement. The extent we rely on Lincoln Park as a source of funding will depend on a number of factors including, the prevailing market price of our common stock and the extent to which we are able to secure working capital from other sources. As of the date of issuance of this Annual Report on Form 10-K, the Company has already received approximately $1.3 million from the Purchase Agreement from the sale of 296,000 shares of common stock to Lincoln Park from the inception of the Purchase Agreement through the date of issuance of this Form 10-K, leaving the Company an additional $18.7 million to draw upon, subject to the Company’s compliance with the terms and conditions of the Purchase Agreement. Although it is difficult to predict the Company’s liquidity requirements, as of December 31, 2020, 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, 2020 and the proceeds received from the Company’s ATM sales during January and February 2021. The Company anticipates that it will continue to incur net losses for the foreseeable future as it continues the development of its clinical drug candidates and preclinical programs and incurs additional costs associated with being a public company. 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 month s 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- 7 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. Amortization is initiated for acquired in-process research and development intangible assets when their useful lives have been determined. These acquired in-process research and development intangible assets are tested at least annually or when a triggering event occurs that could indicate a potential impairment. No impairments of intangible assets were recognized during the years ended December 31, 2020 and 2019. 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, 2020, the Company had 3,457,000 potentially issuable shares of common stock upon the exercise of stock options and 1,955,922 potentially issuable shares of common stock upon the exercise of warrants. At December 31, 2019, the Company had 3,417,000 potentially issuable shares of common stock upon the exercise of stock options and 1,660,874 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. F- 8 The Company records deferred revenues when cash payments are received or due in advance of performance, including amounts which are refundable. The Company’s 2020 revenue was from the sale of MSC’s to one third-party customer. The revenue was recognized when the MSC’s were shipped to the customer. 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 income (loss). Recently Adopted Accounting Pronouncements There were various accounting standards and interpretations issued recently, none of which are expected to a have a material impact on the Company´s consolidated financial position, operations, or cash flows. F- 9 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, 2020 and 2019, the Company recorded a research and development tax credit receivable of $833,024 and $395,850, respectively for R&D expenses incurred in the UK. During the years ended December 31, 2020 and 2019, the Company received $305,593 and $443,929 of R&D tax credit reimbursements, respectively from the UK. According to AUS tax law, the Company is allowed an R&D tax credit that reduces a company’s tax bill in AUS for expenses incurred in R&D subject to certain requirements. The Company’s Australian subsidiary submits R&D tax credit requests annually for research and development expenses incurred. At December 31, 2020 and 2019, the Company recorded a research and development tax credit receivable of $853,041 and $172,289, respectively, for R&D expenses incurred in Australia. During the years ended December 31, 2020 and 2019, the Company received $178,029 and $410,857 of R&D tax credit reimbursements, respectively from Australia. Xencor, Inc. License Agreement On October 3, 2017, the Company entered into a license agreement (“Xencor License Agreement”) with Xencor, Inc. (“Xencor”), which has discovered and developed a proprietary biological molecule that inhibits soluble tumor necrosis factor. 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 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 refers to this licensed protein as DN-TNF and the Company has labeled it as XPro1595 for the Company’s Alzheimer’s and Treatment Resistant Depression indications, Quellor for the COVID-19 indication and LIVNate for the NASH indication. The Company believes the protein has numerous other medical applications. Such additional alternative applications of the technology are available under the license agreement. In connection with the 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. The warrants have an exercise price based on a valuation of the Company at $100,000,000 and expire on October 3, 2023. The aggregate purchase price for the full exercise of the option is $10,000,000 which purchase price shall be pro-rated for any partial exercise of the Warrant. In August 2018, the Company entered into a First Amendment to Stock Issuance Agreement. Pursuant to the amendment, the purchase price for the additional shares may only be paid by cash. 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 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. The Company had no sales of Licensed Products during 2020. F- 10 Under the Xencor License Agreement, the Company also agreed to pay Xencor a percentage of any sublicensing revenue that it receives. 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 (of which none have been met as of December 31, 2020): Each Phase I initiation $ 25,000 Each Phase II initiation $ 250,000 Each Phase III initiation $ 350,000 Each NDA/EMA filing $ 1,000,000 Each NDA/EMA awarded $ 9,000,000 In addition, the Company agreed to pay the licensor a royalty of 1% of net sales during the life of each patent granted to the Company. The License is owned by Immune Ventures. RJ Tesi, the Company’s President and a member of our Board of Directors, David Moss, its Chief Financial Officer and Treasurer and Mark Lowdell, its Chief Scientific Officer, are the owners of Immune Ventures. As of December 31, 2020 and December 31, 2019, 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 1 clinical or equivalent trials by October 29, 2021 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- 11 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, 2020. June 26 of each year 2020-2022 $ 5,000 June 26 of each year 2023-2024 $ 10,000 June 26 of each year 2025 until first commercial sale $ 25,000 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. Moreover, under the PITT Agreement the Licensee is required to make milestone payments as follows: Each Phase I initiation $ 50,000 Each Phase III initiation $ 500,000 First commercial sale of product making use of licensed technology $ 1,250,000 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. University College London License Agreement – MSC On July 19, 2019, the Company entered into license agreement with UCL Business PLC (“UCLB”) with a ten (10) year term. Pursuant to the license agreement, the Company acquired an exclusive license (and a right to sub-license) to the technology and know-how relating to an isolation and commercial scale expansion methodology of GMP grade human umbilical cord mesenchymal stem/stromal cells (“MSC”). In exchange for the license agreement, the Company paid UCLB an initial license fee of approximately $10,000 and shall pay annual licensing fees of approximately $13,000 per year for the remaining term of the agreement beginning in July 2020. The Company will pay UCLB a royalty of 3-3.5%of the net sales value (as defined in the agreement) of all licensed products sold or used by the Company. In the event the Company sub-licenses the technology and know-how, the Company will pay UCLB a royalty of 12 percent of consideration (cash or non-cash) received by the Company in relation to the development or sub-licensing of any of the technology and know-how. The Company had no amounts owed to UCLB as of December 31, 2020. NOTE 5 – LEASE In May 2019, the Company signed a sublease agreement with a related party for office space in La Jolla, California, which serves as the new headquarters of the Company. The lease has a 61-month term, which corresponds to the lease term of the lessor. The lessor is CTI Clinical Trial & Consulting Services (“CTI”). CTI is majority-owned by a member of the Company’s Board of Directors. The lessor may extend its lease for an additional 5 years, and, if it does, the Company may also extend its sublease for 5 years. The Company did not include the option to extend in the calculation of the lease liabilities as such extension is not reasonably certain to occur. Variable lease costs for the Company’s lease consists of operating expenses for the spaces. Below is a summary of the Company’s right-of-use assets and liabilities: F- 12 December 31, 2020 December 31, 2019 Right-of-use asset – related party $ 156,214 $ 191,543 Operating lease, current liability – related party $ 33,873 $ 8,288 Long-term operating lease liability – related party 126,286 160,164 Total lease liability $ 160,159 $ 168,452 Weighted-average remaining lease term 3.5 years 4.5 years Weighted-average discount rate 10.00 % 10.00 % During the years ended December 31, 2020 and 2019, the Company recognized $52,428 and $33,204, respectively, in operating lease expense, which is included in general and administrative expenses in the Company’s consolidated statement of operations. NOTE 6 – RELATED PARTY TRANSACTIONS UCL At December 31, 2020 and 2019, the Company owed UCL Consultants Limited (“UCL”) $33,664 and $9,379, respectively, in connection with medical research performed on behalf of the Company. During the years ending December 31, 2020 and 2019, the Company paid UCL $334,738 and $349,071, 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 At December 31, 2020 and 2019, the Company owed CTI $0 and $280,723, respectively, for medical research performed on behalf of the Company. During the years ending December 31, 2020 and 2019, the Company paid CTI $126,850 and $1,071,126, respectively, for medical research performed on behalf of the Company. During the years ended December 31, 2020 and 2019, the Company paid CTI $25,392 and $49,305, respectively, pursuant to its sublease agreement with CTI. See Note 5. During the year ended December 31, 2020, the Company recorded a capital contribution of $215,761 for the forgiveness of certain accounts payable due to CTI. NOTE 7 – STOCKHOLDERS’ EQUITY Initial Public Offering During February 2019, the Company completed its initial public offering in which the Company sold 1,020,820 shares of its common stock for gross proceeds of $8,166,560 (net proceeds of $7,251,142). April and May 2019 Stock Sale During April and May 2019, the Company sold 522,212 shares of its common stock to certain investors for cash proceeds of $4,727,879, of which the Company’s CEO purchased 11,100 shares for $119,325 of cash and the Company’s CFO purchased 5,000 shares for $53,550 of cash. F- 13 Lincoln Park On May 15, 2019, the Company entered into both a securities purchase agreement and registration rights agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”). Under the terms and subject to the conditions of the securities purchase agreement, the Company has the right to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to $20.0 million in shares of the Company’s common stock, subject to certain limitations, from time to time, over the 24-month period that commenced on May 15, 2019. During May 2019, the Company issued 70,000 shares of the Company’s common stock to Lincoln Park as consideration for Lincoln Park’s commitment to purchase shares of the Company’s common stock under the agreement, and 30,000 shares of common stock were sold to Lincoln Park in an initial purchase for an aggregate gross purchase price of $300,000 ($230,000 net of offering costs). During the year ended December 31, 2020, the Company issued 196,000 shares of its common stock to Lincoln Park for $1,002,644 of cash. At December 31, 2020, Lincoln Park is obligated to purchase up to $18.7 million worth of the Company’s common stock. As contemplated by the securities purchase agreement with Lincoln Park, and so long as the closing price of the Company’s common stock exceeds $3.50 per share, then the Company may, subject to the terms and conditions of the Agreement, direct Lincoln Park, at its sole discretion to purchase up to 20,000 shares of its common stock on any business day. The purchase price will be based on the market prices of the common stock at the time of such purchases as set forth in the securities purchase agreement. In addition to regular purchases, the Company may, subject to the terms and conditions of the Agreement, also direct Lincoln Park to purchase other amounts as accelerated purchases or as additional purchases if the closing sale price of the common stock exceeds certain threshold prices as set forth in the purchase agreement. There are no trading volume requirements or restrictions under the purchase agreement nor any upper limits on the price per share that Lincoln Park must pay for shares of common stock. Purchase and retirement of common stock During January 2020, the Company purchased and cancelled 220,000 shares of its common stock from a shareholder in exchange for $1,012,000 of cash. Immediately following the purchase, the investor owned less than 10% of the outstanding common stock of the Company. Common Stock – At the Market Offering During April 2020, the Company entered into a sales agreement with BTIG, LLC (“BTIG”), as sales agent, to establish an At-The-Market (“ATM”) offering program. The sales agreement with BTIG was subsequently amended during August 2020. The Company was required to pay BTIG a commission of 3% of the gross proceeds from the sale of shares. The ATM program will remain in full force and effect until the earlier of the sale of all of the shares under the ATM program or the termination of the sales agreement by the Company or BTIG. From the inception of the agreement through December 31, 2020, the Company sold 178,600 shares of common stock at an average price of $5.45 per share for gross proceeds of $972,879 (net proceeds of $812,828) and the Company paid BTIG commissions and fees of $79,187. Underwritten Stock Offering During July 2020, the Company completed an underwritten public offering in which it sold 2,500,000 shares of common stock at a public offering price of $10.00 per share. The 2,500,000 shares sold included the full exercise of the underwriters’ option to purchase 326,086 shares at a price of $10.00 per share. Aggregate net proceeds from the underwritten public offering were $23.1 million, net of approximately $1.9 million in underwriting discounts and commissions and offering expenses. F- 14 Common Stock Issued for Services During July 2020, the Company granted a consultant 50,000 fully vested warrants with a 5-year term, of which 25,000 warrants had an exercise price of $5.50 per share and 25,000 warrants had an exercise price of $10.00 per share. The fair value of these warrants was $356,874 based on the Black-Scholes Option Pricing Model and was recorded within general and administrative expense. The assumptions used for these warrants consist of the exercise prices, expected dividends of 0%, expected volatility of 111.67% based on the trading history of similar companies, risk-free rate of 0.30% based on the applicable US Treasury bill rate and an expected life of 5.0 years. During July 2020, the Company issued the consultant 20,000 shares of common stock and cancelled the 50,000 warrants. The 20,000 shares were issued from the Company’s 2019 Incentive Stock Plan and had a fair value of approximately $230,000 based on the market value of the Company’s common stock on the grant date. The Company accounted for the exchange of the warrants for shares of common stock as a modification and recorded no additional expense in connection with the exchange as the fair value of warrants exceeded the fair value of the shares issued. Common Stock Issuable Pacific Seaboard Consulting Agreement On May 16, 2018, the Company entered into a consulting agreement with Pacific Seaboard Investments Ltd. (“Pacific Seaboard”) for corporate governance, compliance services regarding the filing of a listing application and assist with activities related to its initial public offering. In consideration of the consultant’s services, the Company agreed to issue 600,000 shares of its restricted common stock. Pursuant to this agreement, the Company recorded $4,626,000 as common stock issuable for the 600,000 shares of common stock to be issued. During June 2019, the Company issued 400,000 shares of its common stock to Pacific Seaboard, whereby the Company was initially required to issue 600,000 shares to Pacific Seaboard, but subsequently received a waiver from Pacific Seaboard during April 2019 permanently waiving the last 200,000 shares owed. Settlement In November 2016, the Company entered into a settlement agreement whereby the Company agreed to issue 33,335 shares of the Company’s common stock to an individual to settle a claim in full. The obligation was recorded as common stock issuable of $50,000 as of December 31, 2019. During December 2020, the Company issued the 33,335 shares. Stock options In September 2019, upon obtaining stockholder approval, the Company implemented the 2019 Stock Incentive Plan (2019 Stock Plan). The 2019 Stock Plan provides for the grant of incentive stock options, non-statutory stock options, restricted stock and other stock-based compensation awards to employees, officers, directors and consultants of the Company. The administration of the 2019 Stock Plan is under the general supervision of the compensation committee of the board of directors. As of December 31, 2019, the Company had options outstanding to purchase 1,785,000 shares of its common stock, pursuant to the 2019 Stock Plan. The stock options issued pursuant to the 2019 Stock Plan had an aggregated fair value of $5,500,616 that was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 1.71%-1.76% based on the applicable US Treasury bill rates (2) expected life of 6.0 – 10.0 years, (3) expected volatility of approximately 94% based on the trading history of similar companies, and (4) zero expected dividends. During September 2020, the Company granted an employee options to purchase 40,000 shares of its common stock pursuant to the 2019 Incentive Stock Plan. The stock options had a fair value of $339,731 that was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 0.46% based on the applicable US Treasury bill rate (2) expected life of 6.25 years, (3) expected volatility of approximately 106% based on the trading history of similar companies, and (4) zero expected dividends. F- 15 The following table summarizes stock option activity: Number of Shares Weighted- average Exercise Price Weighted-average Remaining Contractual Term (years) Aggregate Intrinsic Value Outstanding at January 1, 2019 1,632,000 $ 7.80 9.07 - Options granted 1,785,000 $ 3.91 - - Options exercised - $ - - - Options cancelled - $ - - - Outstanding at January 1, 2020 3,417,000 $ 5.77 9.03 - Options granted 40,000 $ 10.38 - - Options exercised - $ - - - Options cancelled - $ - - - Outstanding at December 31, 2020 3,457,000 $ 5.82 8.05 $ 39,405,390 Exercisable at December 31, 2020 2,232,910 $ 6.69 7.59 $ 23,511,588 During the years ended December 31, 2020 and 2019, the Company recognized stock-based compensation expense of $2,755,130 and $4,049,333, respectively, related to stock options. As of December 31, 2020, there was $4,077,489 of total unrecognized compensation cost related to non-vested stock options which is expected to be recognized over a weighted-average period of 2.00 years. Warrants In connection with the Company’s initial public offering in February 2019, the Company issued warrants to the placement agents to purchase 40,982 shares of the Company’s common stock at an exercise price of $9.60 per common share, which warrants are exercisable until December 19, 2023. During July 2020, 6,147 of these warrants were exercised on a cashless basis in exchange for 2,400 shares of the Company’s common stock. At December 31, 2020, 34,835 of these warrants are outstanding and the intrinsic value is $265,443. In October 2017, in connection with the Xencor License Agreement, the Company issued fully vested warrants to purchase an additional number of shares of common stock equal to 10% of the fully diluted Company shares immediately following such purchase. See Note 4. These warrants had an intrinsic value of $22,535,812 as of December 31, 2020. On June 30, 2017, the Company issued fully vested warrants with a maturity date of June 30, 2022 and an exercise price of $1.50 to purchase 31,667 shares of the Company’s common stock to a third party in conjunction with common stock sold for cash. These warrants had an intrinsic value of $497,805 as of December 31, 2020. 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, 2020 and 2019 respectively: Year Ended December 31, 2020 Year Ended December 31, 2019 Research and development $ 582,747 $ 1,751,311 General and administrative 2,529,257 2,345,227 Total $ 3,112,004 $ 4,096,538 F- 16 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 are scheduled to expire on December 30, 2021. 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, 2020 and 2019. NOTE 8 – INCOME TAXES The provision for income taxes consists of the following components: December 31, 2020 December 31, 2019 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: December 31, 2020 December 31, 2019 Federal tax benefit at statutory rate (21%) $ (2,540,824 ) $ (1,612,444 ) Stock-based compensation 598,630 804,457 State income tax benefit, net of federal tax effect (411,427 ) (159,154 ) Foreign tax differential (61,005 ) (22,993 ) Research credits 742,218 353,561 Other 1,056 4,622 Forgiveness of stock payable - 323,820 Return to provision adjustment 32,945 67,005 Change in valuation allowance 1,638,407 241,126 Income tax benefit $ - $ - F- 17 The principal components of deferred tax assets and liabilities consist of the following at December 31, 2020 and 2019, respectively: December 31, 2020 December 31, 2019 Deferred tax assets Stock-based compensation $ 563,328 $ 214,970 Federal NOL carryforwards 2,202,080 1,314,314 Foreign NOL carryforwards 781,158 378,875 Total deferred tax assets 3,546,566 1,908,159 Less valuation allowance (3,546,566 ) (1,908,159 ) Net deferred tax assets $ - $ - At December 31, 2020, the Company had a federal net operating loss carryforward of approximately $10.5 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 change in the valuation allowance was $1,638,407 during the year ended December 31, 2020. 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, 2020, and 2019, 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 9 – COLLABORATIVE AGREEMENTS During 2019, the Company was awarded a $1,000,000 grant from the Alzheimer’s Association to advance XPro1595, a novel therapy targeting neuroinflammation as a cause of Alzheimer’s disease. The endowment was awarded under the Part the Cloud to RESCUE grant. During the year ended December 31, 2020 and 2019, the Company received $150,000 and $850,000, respectively, related to the grant, which the Company recorded as a reduction of research and development expense. As of December 31, 2020, the Company has received $1,000,000 of cash proceeds from the Alzheimer’s Association and no additional amounts are available to the Company pursuant to this grant. During the year ended December 31, 2020, the Company was awarded a $500,000 grant from the Amyotrophic Lateral Sclerosis (“ALS”) Association to fund a study of the efficacy of XPro1595 to reverse ALS in vitro and to fund a study of the efficacy of XPro1595 to protect against ALS model phenotypes in vivo. During the year ended December 31, 2020, the Company received $300,000 of cash proceeds pursuant to this grant which the Company recorded as deferred liabilities. During the year ended December 31, 2020, the Company recorded $177,704 as a reduction of deferred liabilities as a result of incurring costs related to the ALS grant. As of December 31, 2020, the Company recorded $122,296 as deferred liabilities in the consolidated balance sheet related to the ALS grant. 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 XPro1595 in patients with treatment resistant depression. As of December 31, 2020, the Company has not received any proceeds pursuant to this grant. NOTE 10 – SUBSEQUENT EVENTS During January and February 2021, the Company sold 1,439,480 shares of its common stock for aggregate gross proceeds of $29.0 million (net proceeds of $28.4 million) under the ATM program. The Company paid BTIG commissions and fees of $581,500 in connection with the sale of these shares. During January 2021, the Company granted 198,549 stock options with an exercise price of $24.82 to executives and directors of the Company which vest over 3-4 years. The fair value of these options was approximately $4.2 million. During February 2021, the Company received $100,000 of cash proceeds pursuant to its grant from the ALS Association. F- 18 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None.