Inmune Bio, Inc. 10-Q

Item 1. Financial Statements INMUNE BIO, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share amounts) (Unaudited) June 30, 2021 December 31, 2020 ASSETS CURRENT ASSETS Cash and cash equivalents $ 39,520 $ 21,967 Research and development tax credit receivable 3,068 1,686 Other tax receivable 51 113 Prepaid expenses 1,395 220 Prepaid expenses – related party 15 - TOTAL CURRENT ASSETS 44,049 23,986 Operating lease – right of use asset – related party 137 156 Acquired in-process research and development intangible assets 16,514 16,514 TOTAL ASSETS $ 60,700 $ 40,656 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES Accounts payable and accrued liabilities $ 2,361 $ 1,518 Accounts payable and accrued liabilities – related parties 9 34 Deferred liabilities 583 190 Operating lease, current liability – related party 36 34 TOTAL CURRENT LIABILITIES 2,989 1,776 Long-term debt, less debt discount 14,348 - Long-term operating lease liability – related party 106 126 Accrued liabilities – long-term 24 - TOTAL LIABILITIES 17,467 1,902 COMMITMENTS AND CONTINGENCIES (Note 10) 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, 15,125,171 and 13,481,283 shares issued and outstanding, respectively 15 13 Additional paid-in capital 87,854 72,105 Accumulated other comprehensive (loss) income ( 50 ) 11 Accumulated deficit ( 44,586 ) ( 33,375 ) TOTAL STOCKHOLDERS’ EQUITY 43,233 38,754 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 60,700 $ 40,656 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 1 INMUNE BIO, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share amounts) (Unaudited) For the Three Months Ended June 30, For the Six Months Ended June 30, 2021 2020 2021 2020 REVENUE $ - $ - $ 4 $ - OPERATING EXPENSES General and administrative 2,090 1,204 4,151 2,504 Research and development 4,464 903 6,955 1,696 Total operating expenses 6,554 2,107 11,106 4,200 LOSS FROM OPERATIONS ( 6,554 ) ( 2,107 ) ( 11,102 ) ( 4,200 ) OTHER (EXPENSE) INCOME ( 101 ) ( 1 ) ( 109 ) 22 NET LOSS $ ( 6,655 ) $ ( 2,108 ) $ ( 11,211 ) $ ( 4,178 ) Net loss per common share – basic and diluted $ ( 0.44 ) $ ( 0.20 ) $ ( 0.77 ) $ ( 0.39 ) Weighted average common shares outstanding - basic and diluted 14,974,953 10,800,708 14,650,608 10,774,004 COMPREHENSIVE LOSS Net loss $ ( 6,655 ) $ ( 2,108 ) $ ( 11,211 ) $ ( 4,178 ) Other comprehensive income (loss) - foreign currency translation ( 62 ) 39 ( 61 ) 18 Total comprehensive loss $ ( 6,717 ) $ ( 2,069 ) $ ( 11,272 ) $ ( 4,160 ) The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 2 INMUNE BIO, INC. CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY FOR THE SIX MONTHS ENDED JUNE 30, 2021 (In thousands, except share amounts) (Unaudited) Accumulated Additional Other Total Common Stock Paid-In Comprehensive Accumulated Stockholders’ Shares Amount Capital Income Deficit Equity Balance as of December 31, 2020 13,481,283 $ 13 $ 72,105 $ 11 $ ( 33,375 ) $ 38,754 Issuance of common stock for cash 1,439,480 2 28,444 - - 28,446 Exercise of warrants for cash 11,875 - 18 - - 18 Stock-based compensation - - 899 - - 899 Gain on foreign currency translation - - - 1 - 1 Net loss - - - - ( 4,556 ) ( 4,556 ) Balance as of March 31, 2021 14,932,638 $ 15 $ 101,466 $ 12 $ ( 37,931 ) $ 63,562 Stock-based compensation - - 769 - - 769 Settlement of Xencor warrant for cash and common stock 192,533 - ( 15,000 ) - - ( 15,000 ) Warrants issued to lenders as debt inducement - - 619 - - 619 Loss on foreign currency translation - - - ( 62 ) - ( 62 ) Net loss - - - - ( 6,655 ) ( 6,655 ) Balance as of June 30, 2021 15,125,171 15 87,854 ( 50 ) ( 44,586 ) 43,233 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 3 CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY FOR THE SIX MONTHS ENDED JUNE 30, 2020 (In thousands, except share amounts) (Unaudited) Accumulated Additional Common Other Total Common Stock Paid-In Stock Comprehensive Accumulated Stockholders’ Shares Amount Capital Issuable Loss Deficit Equity Balance as of December 31, 2019 10,770,948 $ 11 $ 44,834 $ 50 $ ( 9 ) $ ( 21,276 ) $ 23,610 Issuance of common stock and warrants for cash, net 196,000 - 1,003 - - - 1,003 Acquisition and retirement of common stock ( 220,000 ) - ( 1,012 ) - - - ( 1,012 ) Capital contribution - - 216 - - - 216 Stock-based compensation - - 682 - - - 682 Loss on foreign currency translation - - - - ( 21 ) - ( 21 ) Net loss - - - - - ( 2,070 ) ( 2,070 ) Balance as of March 31, 2020 10,746,948 $ 11 $ 45,723 $ 50 $ ( 30 ) $ ( 23,346 ) $ 22,408 Issuance of common stock for cash, net 150,682 - 664 - - - 664 Stock-based compensation - - 681 - - - 681 Loss on foreign currency translation - - - - 39 - 39 Net loss - - - - - ( 2,108 ) ( 2,108 ) Balance at June 30, 2020 10,897,630 11 47,068 50 9 ( 25,454 ) 21,684 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 4 INMUNE BIO, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands) (Unaudited) For the Six Months Ended June 30, 2021 2020 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $ ( 11,211 ) $ ( 4,178 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 1,668 1,363 Accretion of debt discount 16 - Changes in operating assets and liabilities: Research and development tax credit receivable ( 1,382 ) ( 477 ) Other tax receivable 62 ( 78 ) Prepaid expenses ( 1,175 ) ( 244 ) Prepaid expenses – related party ( 15 ) 26 Accounts payable and accrued liabilities 843 223 Accounts payable and accrued liabilities – related parties ( 25 ) 149 Deferred liabilities 393 362 Accrued liabilities – long term 24 - Operating lease liability – related party 1 1 Net cash used in operating activities ( 10,801 ) ( 2,853 ) CASH FLOWS 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 28,446 1,667 Net proceeds from the exercise of warrants 18 - Purchase of common stock - ( 1,012 ) Net cash provided by financing activities 43,415 655 Impact on cash from foreign currency translation ( 61 ) 18 NET INCREASE (DECREASE) IN CASH 17,553 ( 2,180 ) CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 21,967 6,996 CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 39,520 $ 4,816 SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: Cash paid for income taxes $ - $ - Cash paid for interest expense $ - $ - 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 $ - Capital contribution $ - $ 216 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 5 INMUNE BIO, INC. NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS NOTE 1 –ORGANIZATION AND DESCRIPTION OF BUSINESS 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. NOTE 2 – LIQUIDITY As of June 30, 2021, the Company had an accumulated deficit of approximately $ 44.6 million 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 2021, the Company completed a registered direct public offering in which it sold 1,818,182 shares of common stock to investors for estimated net proceeds of $ 36.9 million. ● During June 2021, the Company entered into a loan and security agreement and drew down a $ 15.0 million term loan. ● During March 2021, the Company entered into a sales agreement with BTIG, LLC (“BTIG”), as sales agent, to establish an At-The-Market (“ATM”) offering program of up to $ 45 million of common stock (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. The Company is required to pay BTIG a commission of 3 % of the gross proceeds from the sale of shares. During July 2021, the Company sold 713,192 shares of its common stock at an average price of $ 21.73 through the 2021 ATM for net proceeds of $ 15.0 million. ● 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. Aggregate net proceeds from the underwritten public offering were approximately $ 23.1 million, net of $ 1.9 million in underwriting discounts and commissions and offering expenses. ● During April 2020, the Company entered into a sales agreement with BTIG, as sales agent, to establish an ATM offering program 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. 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 the six months ended June 30, 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 $ 28.4 million. As of June 30, 2021, sales of our common stock pursuant to the 2020 ATM have been completed. Although it is difficult to predict the Company’s liquidity requirements, as of June 30, 2021, 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 Quarterly Report on Form 10-Q based on the balance of cash available as of June 30, 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. 6 NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying financial statements are presented in U.S. dollars and have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”), and pursuant to the accounting and disclosure rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The consolidated financial statements include the accounts of INmune Bio, Inc. and its subsidiaries. Intercompany transactions and balances have been eliminated. In the opinion of management, the interim financial information includes all normal recurring adjustments necessary for a fair statement of the results for the interim periods. These unaudited consolidated interim financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2020 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 4, 2021. 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. 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. The Company’s significant estimates and assumptions include the valuation of stock-based compensation instruments, and the net realizable value of research and development tax credit receivables. Actual results and outcomes may differ from management’s estimates and assumptions. Cash and Cash Equivalents The Company considers all short-term, highly liquid investments with an original maturity at the date of purchase of three months or less to be cash equivalents. The Company maintains cash balances that may be uninsured or in deposit accounts that exceed Federal Deposit Insurance Corporation limits. The Company maintains its cash deposits with major financial institutions. 7 Research and Development Tax Incentive Receivable The Company, through its wholly-owned subsidiary in Australia (“AUS”), 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 (“UK”), 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. 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 June 30, 2021 and 2020, the Company had potentially issuable shares as follows: June 30, 2021 2020 Stock options 3,892,000 3,417,000 Warrants 100,013 1,674,931 Total 3,992,013 5,091,931 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. 8 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. Subsequent Events The Company evaluates events that have occurred after the balance sheet date of June 30, 2021, through the date which the financial statements are issued. 9 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 June 30, 2021 and December 31, 2020, the Company recorded a research and development tax credit receivable in the amount of $ 1,787,000 and $ 833,000 , respectively. During the six months ended June 30, 2021 and 2020, the Company received $ 0 of R&D tax credit reimbursements from the UK. The Company expects to receive R&D tax credit reimbursements during the second half of 2021. 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 June 30, 2021 and December 31, 2020, the Company recorded a research and development tax credit receivable of $ 1,281,000 and $ 853,000 , respectively, for R&D expenses incurred in Australia. During the six months ended June 30, 2021 and 2020, the Company received $ 0 R&D tax credit reimbursements from Australia. The Company expects to receive R&D tax credit reimbursements during the second half of 2021. 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 “XPro1595” 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. The aggregate purchase price for the full exercise of the option 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 royalty on Net Sales of all Licensed Products in a given calendar year, which are payable on a country-by- country and licensed product by licensed product basis until the date that is the later of (a) the expiration of the last to expire valid claim covering such Licensed Product in such country or (b) ten years following the first sale to a third party of the licensed product in such country. Under the Xencor License Agreement, the Company also agreed to pay Xencor a percentage of any sublicensing revenue that it receives. On June 10, 2021, the Company and Xencor entered into an Option Cancellation Agreement whereby Xencor terminated its warrant to purchase 10 % of the fully diluted shares of the Company in exchange for a cash payment of $ 15,000,000 and 192,533 shares of the Company’s common stock with a fair value of $ 3,300,000 based on the market price of the common stock as of June 10, 2021, which the Company issued in June 2021. The Company agreed to file a registration statement covering the resale of these shares on or before the earlier to occur of September 8, 2021, or the date on which the Company next files a registration statement (other than a registration statement on Form S-8 or any statement on Form S-3 previously filed) and 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 (of which none were met as of June 30, 2021): (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 10 In addition, the Company agreed to pay Immune Ventures a royalty of 1 % of net sales during the life of each patent granted to the Company. 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 June 30, 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 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. During July 2021, the Company initiated a Phase I clinical trial using INKmune and the Company paid Immune Ventures a $ 25,000 milestone payment. University of Pittsburg License Agreement On October 3, 2017, the Company entered into an Assignment and Assumption Agreement with Immune Ventures related to intellectual property licensed from the University of Pittsburgh. Pursuant to the Assignment and Assumption Agreement (“Assignment Agreement”), Immune Ventures assigned all of its rights, obligations and liabilities under an Exclusive License Agreement between the University of Pittsburgh – Of the Commonwealth System of Higher Education (“Licensor”) and Immune Ventures to INmune Bio (“Licensee”), (the “PITT Agreement”). Consideration under the PITT Agreement includes: (i) annual maintenance fees, (ii) royalty payments based on the sale of products making use of the licensed technology, and (iii) milestone payments. Annual maintenance fees under the PITT Agreement include the following: (in thousands) June 26 of each year 2021-2022 $ 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. 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 had no amounts owed pursuant to the PITT Agreement as of June 30, 2021. The PITT Agreement expires upon the earlier of: (i) expiration of the last claim of the Patent Rights (as defined in the PITT Agreement) 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). 11 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 $10,000 and shall pay annual licensing fees of approximately $13,000 per year for the remaining term of the agreement. 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 twelve (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. On July 15, 2021, the Company notified UCLB of its intent to terminate the license agreement. NOTE 5 – LEASE In May 2019, the Company signed a sublease agreement with a related party for office space in La Jolla, California. 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 as of June 30, 2021: (in thousands, except years and rate) Right-of-use asset – related party $ 137 Operating lease, current liability – related party $ 36 Long-term operating lease liability – related party 106 Total lease liability $ 142 Weighted-average remaining lease term 3.0 years Weighted-average discount rate 10.00 % NOTE 6 – RELATED PARTY TRANSACTIONS UCL At June 30, 2021 and December 31, 2020, the Company owed UCL Consultants Limited (“UCL”) $ 9,000 and $ 34,000 , respectively, in connection with medical research performed on behalf of the Company. At June 30, 2021 and December 31, 2020, the Company recorded prepaid expenses of $ 15,000 and $ 0 , respectively, for medical research to be performed on behalf of the Company by UCL. During the six months ended June 30, 2021 and 2020, the Company paid UCL $ 132,000 and $ 0 , 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. 12 CTI During the six months ended June 30, 2021 and 2020, the Company paid CTI $ 0 and $ 127,000 , respectively, for medical research performed on behalf of the Company. During the six months ended June 30, 2020, the Company recorded a capital contribution of $ 216,000 for the forgiveness of certain accounts payable due to CTI. The Company had no amounts payable to CTI as of June 30, 2021 and December 31, 2020. NOTE 7 – 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. The Company paid the Lenders $ 47,000 to access the term loan, which has been included as a component of the debt discount and is amortized to interest expense over the term of the loan. The term loan and debt discount are as follows as of June 30, 2021: (in thousands) Term Loan $ 15,000 Less: debt discount and financing costs, net ( 652 ) Less: current portion - Long-term debt $ 14,348 For the three and six months ended June 30, 2021 the Company recognized interest expense of $ 0.1 million related to the Term Loan. The term loan repayment schedule provides for interest only payments beginning on July 1, 2021, and continuing for 12 months, followed by 30 consecutive equal monthly installments of principal, plus monthly payments of accrued interest, starting on July 1, 2022 and continuing through the maturity date of January 1, 2025 . The interest-only period may be extended for one year upon the achievement of an equity milestone as fully defined in the Term Loan . 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 June 30, 2021, the interest rate was 7.75 %. 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) 3 % of the original principal amount borrowed for any prepayment on or prior to the first anniversary of the loan, (ii) 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 (iii) 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 June 30, 2021: (in thousands, except years) 2021 $ - 2022 2,773 2023 5,877 2024 6,350 Total debt $ 15,000 13 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. Under the Term Loan, the Company agreed to issue the Lenders warrants to purchase shares of its common stock. On June 10, 2021, upon the draw of the term loan, the Company issued to the Lenders warrants to purchase in aggregate 45,386 shares of common stock at a per share exercise price of $ 14.05 . The warrants were immediately exercisable upon issuance, and other than in connection with certain mergers or acquisitions, will expire on the ten-year anniversary of the date of issuance. The fair value of the warrants was estimated at $ 0.6 million using a Black-Scholes model and assuming: (i) expected volatility of 103 % based on the trading history of similar companies , (ii) discount rate of 1.45 % based on the applicable US Treasury bill rate , (iii) an expected life of 10 years and (iv) zero expected dividends. The fair value of the warrants was included as a discount to the term loan and also as a component of additional paid-in capital at June 30, 2021. NOTE 8 – STOCKHOLDERS’ EQUITY 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 had the right to sell to Lincoln Park, and Lincoln Park was obligated to purchase, up to $ 20.0 million in shares of the Company’s common stock, subject to certain limitations, over the 24-month period that commenced on May 15, 2019. During the six months ended June 30, 2020, the Company issued 196,000 shares of its common stock to Lincoln Park for approximately $ 1.0 million of cash. During April 2021, the Company terminated the securities purchase agreement with Lincoln Park. 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 approximately $ 1.0 million of cash. Common Stock – At the Market Offering During the six months ended June 30, 2020, we issued and sold 150,682 shares of common stock at an average price of $ 5.44 per share under the 2020 ATM program. The aggregate net proceeds were approximately $ 0.7 million after BTIG’s commission and other offering expenses. During the six months ended June 30, 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 program. The aggregate net proceeds were approximately $ 28.4 million after BTIG’s commission and other offering expenses. 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). 14 Stock options During January 2021, the Company granted certain employees and directors options to purchase 198,549 shares of its common stock pursuant to the 2017 and 2019 Incentive Stock Plans. The stock options have a fair value of approximately $ 4.2 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 0.78 % based on the applicable US Treasury bill rate (2) expected life of 6.0 - 6.25 years, (3) expected volatility of approximately 113 % - 114 % based on the trading history of similar companies, and (4) zero expected dividends. During June 2021, the Company granted certain employees and directors options to purchase 236,451 shares of its common stock pursuant to the 2021 Incentive Stock Plan. The stock options have a fair value of approximately $ 3.3 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 1.23 % based on the applicable US Treasury bill rate (2) expected life of 6.0 - 6.25 years, (3) expected volatility of approximately 107 % - 108 % based on the trading history of similar companies, and (4) zero expected dividends. The following table summarizes stock option activity during the six months ended June 30, 2021: (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 $ 39,405 Options granted 435,000 $ 20.84 10.00 - Options exercised - $ - - - Options cancelled - $ - - - Outstanding at June 30, 2021 3,892,000 $ 7.50 7.81 $ 40,634 Exercisable at June 30, 2021 2,570,000 $ 6.43 7.25 $ 28,660 During the six months ended June 30, 2021 and 2020, the Company recognized stock-based compensation expense of approximately $ 1.7 million and $ 1.4 million, respectively, related to the vesting of stock options. As of June 30, 2021, there was approximately $ 9.9 million of total unrecognized compensation cost related to non-vested stock options which is expected to be recognized over a weighted-average period of 2.87 years. Warrants The Company issued 45,386 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 . The warrants have a fair value of approximately $ 0.6 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 1.45 % based on the applicable US Treasury bill rate (2) expected life of 10.0 years, (3) expected volatility of approximately 103 % based on the trading history of similar companies, and (4) zero expected dividends. At June 30, 2021, the intrinsic value of these warrants is $ 160,000 . In connection with the Company’s initial public offering in February 2019, the Company issued warrants to the placement agents to purchase the Company’s common stock at an exercise price of $ 9.60 per common share, which warrants are exercisable until December 19, 2023. At June 30, 2021, 34,835 of these warrants are outstanding and the intrinsic value is $ 278,000 . On June 30, 2017, the Company issued fully vested warrants to purchase 31,667 shares of the Company’s common stock to a third party in conjunction with the common stock sold for cash. The warrants have a $ 1.50 exercise price and expire on June 30, 2022 . During the six months ended June 30, 2021, 11,875 of these warrants were exercised for cash proceeds of $ 18,000 . At June 30, 2021, 19,792 of these warrants are outstanding, with an intrinsic value of $ 318,000 . Stock-based Compensation by Class of Expense The following summarizes the components of stock-based compensation expense in the consolidated statements of operations for the three and six months ended June 30, 2021 and 2020 respectively: (in thousands) Three Months Ended June 30, 2021 Three Months Ended June 30, 2020 Six Months Ended June 30, 2021 Six Months Ended June 30, 2020 Research and development $ 199 $ 139 $ 385 $ 277 General and administrative 570 543 1,283 1,086 Total $ 769 $ 682 $ 1,668 $ 1,363 15 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. NOTE 9 – COLLABORATIVE AGREEMENTS During 2020, the Company was awarded a $0.5 million 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 six months ended June 30, 2021 and 2020, the Company received $ 0.1 million and $ 0.3 million, respectively, of cash proceeds pursuant to this grant which the Company recorded as deferred liabilities. The Company offsets costs incurred related to this research against the grants. As of June 30, 2021 and December 31, 2020, the Company recorded approximately $ 0.2 million and $ 0.1 million, respectively, 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 June 30, 2021, the Company has not received any proceeds pursuant to this grant. NOTE 10 – COMMITMENTS AND CONTINGENCIES Lease In May 2019, the Company signed a sublease agreement with a related party for office space in La Jolla, California. The lease has a 61 -month term, which corresponds to the lease term of the lessor. The lessor is CTI. Future minimum payments pursuant to the lease are as follows: (in thousands, except years) 2021 $ 26 2022 53 2023 55 2024 33 Total $ 167 During the three and six months ended June 30, 2021, the Company recognized $ 13,000 and $ 26,000 , 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 11 – SUBSEQUENT EVENTS During July 2021, the Company sold 713,192 shares of its common stock through 2021 ATM program for net proceeds of $ 15.0 million. During July 2021, the Company sold 1,818,182 shares of its common stock to investors through a registered direct offering for estimated net proceeds of $ 36.9 million. During July 2021, the Company awarded 333,000 stock options to employees with a 3 -year vesting term and an estimated fair value of $ 5.6 million. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 1.04 -1.19% based on the applicable US Treasury bill rate (2) expected life of 6.0 years, (3) expected volatility of approximately 108 % based on the trading history of similar companies, and (4) zero expected dividends. During July 2021, certain employees of the Company exercised 45,000 stock options in exchange for approximately $ 176,000 of cash proceeds. 16