Document and Entity Information
Document and Entity Information | 3 Months Ended |
Mar. 31, 2019 | |
Document And Entity Information [Abstract] | |
Entity Registrant Name | Inmune Bio, Inc. |
Entity Central Index Key | 0001711754 |
Entity Filer Category | Non-accelerated Filer |
Document Type | S-1 |
Document Period End Date | Mar. 31, 2019 |
Amendment Flag | false |
Entity Small Business | true |
Entity Emerging Growth Company | true |
Entity Ex Transition Period | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | |||
Cash and cash equivalents | $ 6,048,922 | $ 186,204 | $ 1,370,711 |
Research and development tax credit receivable | 605,731 | 592,215 | 106,866 |
Other tax receivable | 165,558 | 37,382 | 111,618 |
Joint development cost receivable | 34,525 | 17,989 | 109,124 |
Prepaid expenses | 275,774 | 15,552 | 42,647 |
Prepaid expenses - related party | 158,504 | ||
Total current assets | 7,130,510 | 849,342 | 1,899,470 |
Acquired in-process research and development intangible assets | 16,514,000 | 16,514,000 | 16,514,000 |
Total assets | 23,644,510 | 17,363,342 | 18,413,470 |
Current liabilities: | |||
Accounts payable and accrued liabilities | 471,640 | 814,746 | 126,257 |
Accounts payable and accrued liabilities - related parties | 9,220 | 9,020 | 183,460 |
Deferred grant income | 300,000 | ||
Total current liabilities | 780,860 | 823,766 | 309,717 |
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, 9,740,261, 8,719,441 and 8,319,441 shares issued and outstanding, respectively | 9,740 | 8,719 | 8,319 |
Additional paid-in capital | 33,671,016 | 25,446,196 | 19,171,237 |
Common stock issuable | 4,676,000 | 4,676,000 | 50,000 |
Accumulated other comprehensive income (loss) | 5,807 | 6,529 | 32,042 |
Accumulated deficit | (15,498,913) | (13,597,868) | (1,157,845) |
Total stockholders' equity | 22,863,650 | 16,539,576 | 18,103,753 |
Total liabilities and stockholders' equity | $ 23,644,510 | $ 17,363,342 | $ 18,413,470 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parentheticals) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Statement of Financial Position [Abstract] | |||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 | 200,000,000 |
Common stock, shares, issued | 9,740,261 | 8,719,441 | 8,319,441 |
Common stock, shares, outstanding | 9,740,261 | 8,719,441 | 8,319,441 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Statement [Abstract] | ||||
Revenue | $ 0 | $ 0 | $ 0 | $ 0 |
Operating expenses: | ||||
Research and development | 101,592 | 104,011 | 1,105,389 | 435,362 |
General and administrative | 1,809,495 | 2,742,373 | 11,334,634 | 546,118 |
Total operating expenses | 1,911,087 | 2,846,384 | 12,440,023 | 981,480 |
Loss from operations | (1,911,087) | (2,846,384) | (12,440,023) | (981,480) |
Other income: (Expense) | ||||
Other expense | (6) | |||
Gain on legal settlements | 150,000 | |||
Other income | 10,042 | |||
Total other income | 10,042 | 149,994 | ||
Net loss | $ (1,901,045) | $ (2,846,384) | $ (12,440,023) | $ (831,486) |
Basic and diluted loss per common share | $ (0.20) | $ (0.33) | $ (1.43) | $ (0.13) |
Weighted average number of common shares outstanding - basic and diluted | 9,388,645 | 8,546,108 | 8,676,701 | 6,564,326 |
COMPREHENSIVE LOSS | ||||
Net loss | $ (1,901,045) | $ (2,846,384) | $ (12,440,023) | $ (831,486) |
Other comprehensive income (loss) - gain (loss) on foreign currency translation | (722) | 14,430 | (25,513) | 34,886 |
Total comprehensive loss | $ (1,901,767) | $ (2,831,954) | $ (12,465,536) | $ (796,600) |
CONSOLIDATED STATEMENT OF CHANG
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) | Common Stock | Additional Paid-In Capital | Common Stock Issuable | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Total |
Balances at Dec. 31, 2016 | $ 5,067 | $ 124,933 | $ 50,000 | $ (2,844) | $ (326,359) | $ (149,203) |
Balances (in shares) at Dec. 31, 2016 | 5,066,667 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock and warrants in exchange for intangible assets | $ 1,585 | 16,412,415 | 16,414,000 | |||
Issuance of common stock and warrants in exchange for intangible assets (in shares) | 1,585,000 | |||||
Issuance of common stock for conversion of short term debt - related party | $ 233 | 349,767 | 350,000 | |||
Issuance of common stock for conversion of short term debt - related party (in shares) | 233,345 | |||||
Issuance of common stock for cash | $ 1,393 | 2,054,607 | $ 2,056,000 | |||
Issuance of common stock for cash (in shares) | 1,393,335 | 1,393,335 | ||||
Issuance of common stock for settlement of stock payable | $ 20 | 29,980 | $ 30,000 | |||
Issuance of common stock for settlement of stock payable (in shares) | 20,000 | |||||
Stock-based compensation | $ 21 | 199,535 | 199,556 | |||
Stock-based compensation (in shares) | 21,094 | |||||
Gain (loss) on foreign currency translation | 34,886 | 34,886 | ||||
Net loss | (831,486) | (831,486) | ||||
Balances at Dec. 31, 2017 | $ 8,319 | 19,171,237 | 50,000 | 32,042 | (1,157,845) | $ 18,103,753 |
Balances (in shares) at Dec. 31, 2017 | 8,319,441 | 8,319,441 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock for cash | $ 400 | 899,600 | $ 900,000 | |||
Issuance of common stock for cash (in shares) | 400,000 | |||||
Stock-based compensation | 2,461,429 | 2,461,429 | ||||
Gain (loss) on foreign currency translation | 14,430 | 14,430 | ||||
Net loss | (2,846,384) | (2,846,384) | ||||
Balances at Mar. 31, 2018 | $ 8,719 | 22,532,266 | 50,000 | 46,472 | (4,004,229) | 18,633,228 |
Balances (in shares) at Mar. 31, 2018 | 8,719,441 | |||||
Balances at Dec. 31, 2017 | $ 8,319 | 19,171,237 | 50,000 | 32,042 | (1,157,845) | $ 18,103,753 |
Balances (in shares) at Dec. 31, 2017 | 8,319,441 | 8,319,441 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock for cash | $ 400 | 899,600 | $ 900,000 | |||
Issuance of common stock for cash (in shares) | 400,000 | 400,000 | ||||
Value of shares issued for consideration | 4,626,000 | $ 4,626,000 | ||||
Stock-based compensation | 5,375,359 | |||||
Gain (loss) on foreign currency translation | (25,513) | (25,513) | ||||
Net loss | (12,440,023) | (12,440,023) | ||||
Balances at Dec. 31, 2018 | $ 8,719 | 25,446,196 | 4,676,000 | 6,529 | (13,597,868) | $ 16,539,576 |
Balances (in shares) at Dec. 31, 2018 | 8,719,441 | 8,719,441 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock and warrants for cash, net of issuance costs | $ 1,021 | 7,250,121 | $ 7,251,142 | |||
Issuance of common stock and warrants for cash, net of issuance costs (in shares) | 1,020,820 | |||||
Stock-based compensation | 974,699 | 974,699 | ||||
Gain (loss) on foreign currency translation | (722) | (722) | ||||
Net loss | (1,901,045) | (1,901,045) | ||||
Balances at Mar. 31, 2019 | $ 9,740 | $ 33,671,016 | $ 4,676,000 | $ 5,807 | $ (15,498,913) | $ 22,863,650 |
Balances (in shares) at Mar. 31, 2019 | 9,740,261 | 9,740,261 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities: | ||||
Net loss | $ (1,901,045) | $ (2,846,384) | $ (12,440,023) | $ (831,486) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Stock-based compensation | 974,699 | 2,461,429 | 10,001,359 | 199,556 |
Gain on legal settlements | (150,000) | |||
Changes in operating assets and liabilities: | ||||
Research and development tax credit receivable | (13,516) | (54,798) | (485,349) | (38,000) |
Other tax receivable | (128,176) | 55,917 | 74,236 | (76,379) |
Joint development cost receivable | (16,536) | 98,213 | 91,135 | 47,257 |
Prepaid expenses | (260,222) | 18,704 | 27,095 | (39,647) |
Prepaid expenses - related party | 51,429 | 158,504 | (112,042) | |
Accounts payable and accrued liabilities | (343,106) | 60,199 | 688,489 | 68,548 |
Accounts payable and accrued liabilities - related parties | 200 | (173,550) | (174,440) | 170,359 |
Deferred grant income | 300,000 | |||
Net cash used in operating activities | (1,387,702) | (328,841) | (2,058,994) | (761,834) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||||
Cash paid for acquired in-process research and development intangible assets | (100,000) | |||
Net cash used in investing activities | (100,000) | |||
Cash flows from financing activities: | ||||
Net proceeds from sale of common stock | 7,251,142 | 900,000 | 900,000 | 2,056,000 |
Net cash provided by financing activities | 7,251,142 | 900,000 | 900,000 | 2,056,000 |
Impact on cash from foreign currency translation | (722) | 14,430 | (25,513) | 34,886 |
Net increase in cash and cash equivalents | 5,862,718 | 585,589 | (1,184,507) | 1,229,052 |
Cash and cash equivalents - beginning | 186,204 | 1,370,711 | 1,370,711 | 141,659 |
Cash and cash equivalents - ending | 6,048,922 | 1,956,300 | 186,204 | 1,370,711 |
SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | ||||
Cash paid for income taxes | 0 | 0 | 0 | 0 |
Cash paid for interest expense | 0 | $ 0 | $ 0 | 0 |
Noncash investing and financing activity: | ||||
Issuance of common stock and warrants for acquired in-process research and development intangible asset | 16,414,000 | |||
Conversion of related party debt to common stock | 350,000 | |||
Issuance of common stock for settlement of accounts payable | $ 30,000 | |||
Issuance of warrants to placement agents | $ 247,452 |
ORGANIZATION AND BASIS OF PRESE
ORGANIZATION AND BASIS OF PRESENTATION | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Organization And Basis Of Presentation [Abstract] | ||
ORGANIZATION AND BASIS OF PRESENTATION | Note 1 - Business Organization, Nature of Operations INmune Bio, Inc. (“INmune”) was organized in the State of Nevada on September 25, 2015 and is an early stage specialty pharmaceutical company focused on developing and commercializing our product candidates to treat diseases where the innate immune system is not functioning normally and contributing to the patient’s disease. INmune’s proprietary is to focus on the innate immune system that include natural killer cells (“NK cells”), myeloid derived suppressor cells (“MDSC cells”), microglial cells and dendritic cells (“DC cells”), which are believed to offer unique therapeutic opportunities. INmune plans to develop their three existing drug platforms: INKmune (“INKmune”) which primes NK cells, INB03 (“INB03”) which down regulates MDSC cells and XPro1595 that targets microglial cell activation in the brain – a cause of neuroinflammation. Together or individually, the Company expects that these therapies will harness the innate immune system to provide a unique set of therapies for patients with innate immune system dysfunction. INmune Bio International Ltd (England) (“INmune UK”) is a wholly owned subsidiary of INmune that was formed on April 6, 2016 in the United Kingdom (“UK”). INmune UK was duly organized under the laws of England and has 1,000 shares owned by INmune. The Company will perform its drug manufacturing and currently performs its drug research and development in the UK and will continue to perform research and development activities in this region. The UK has a research and development (“R&D”) rebate program that allows the Company to recover some of its R&D expenses (see further discussion in Note 4). On March 28, 2018, the Company acquired 100% of INmune Bio Australia Pty Ltd (Australia) (“INmune Australia”). INmune Australia had no assets or liabilities on the acquisition date, and was acquired for approximately $2,000. INmune Australia performs drug research and development and clinical trials in Australia and will continue to perform research and development activities in this region. Australia has an R&D rebate program that allows the Company to recover some of its R&D expenses (see further discussion in Note 4). | NOTE 1 – ORGANIZATION AND BASIS OF PRESENTATION Organization INmune Bio, Inc. (“INmune”) was originally organized in the State of Nevada on September 25, 2015 and is an early stage specialty pharmaceutical company focused on developing and commercializing our product candidates to treat diseases where the innate immune system is not functioning normally and contributing to the patient’s disease. INmune’s proprietary is to focus on the innate immune system that include natural killer cells (“NK cells”), myeloid derived suppressor cells (“MDSC cells”) and dendritic cells (“DC cells”), which are believed to offer unique therapeutic opportunities. INmune plans to develop their two existing drug platforms: INKmune (“INKmune”) which primes NK cells and INB03 (“INB03”) which down regulates MDSC cells. Together or individually, the Company expects that these therapies will harness the innate immune system to provide a unique set of therapies for patients with cancer. INmune Bio International Ltd (England) (“INmune UK”) is a wholly owned subsidiary of INmune that was formed on April 6, 2016 in the United Kingdom (“UK”). INmune UK was duly organized under the laws of England and has 1,000 shares owned by INmune. The Company will perform its drug manufacturing and currently performs its drug research and development in the UK and will continue to perform research and development activities in this region. The UK has a research and development (“R&D”) rebate program that allows the Company to recover some of its R&D expenses (see further discussion in Note 4). On March 28, 2018, the Company acquired 100% of INmune Bio Australia Pty Ltd (Australia) (“INmune Australia”). INmune Australia had no assets or liabilities on the acquisition date and was acquired for approximately $2,000. INmune Australia performs drug research and development and clinical trials in Australia and will continue to perform research and development activities in this region. Australia has an R&D rebate program that allows the Company to recover some of its R&D expenses (see further discussion in Note 4). 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 (“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 GAAP and include the accounts of INmune and its wholly-owned subsidiaries, INmune UK and INmune Australia (collectively the “Company”). All significant intercompany accounts and transactions have been eliminated. |
GOING CONCERN
GOING CONCERN | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Going Concern [Abstract] | ||
GOING CONCERN | Note 2 – Going Concern As of March 31, 2019, the Company had an accumulated deficit of $15,498,913 and experienced losses since its inception. Losses have principally occurred as a result of 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. These factors raise substantial doubt about the Company’s ability to continue as a going concern. These financial statements do not include any adjustments to reflect the possible future effect on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the outcome of these uncertainties. Management plans to seek additional funding through the issuance of common stock for cash and by implementing its strategic plan to develop its pharmaceutical products and allow the opportunity for the Company to continue as a going concern, however there cannot be any assurance that we will be successful in doing so. The Company raised net proceeds of approximately $7.3 million in February 2019, received $0.6 million in grants in March 2019 and expects to receive an additional $0.4 million in grants on, or prior to, the first quarter of 2020, which the Company estimates should meet its planned operating requirements into the first quarter of 2020. The Company plans to seek to raise additional capital to meet its future operating requirements until such time as it develops a recurring source of revenues, which is not expected for several years. The amount and timing of these capital raises is subject to general market conditions. There cannot be any assurance that the Company will be able to complete these capital raises. | NOTE 2 – GOING CONCERN As of December 31, 2018, the Company had an accumulated deficit of $13,597,868 and experienced losses since its inception. Losses have principally occurred as a result of 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. These factors raise substantial doubt about the Company’s ability to continue as a going concern. These financial statements do not include any adjustments to reflect the possible future effect on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the outcome of these uncertainties. Management plans to seek additional funding through the issuance of common stock for cash and by implementing its strategic plan to develop its pharmaceutical products and allow the opportunity for the Company to continue as a going concern, however there cannot be any assurance that we will be successful in doing so. The Company raised net proceeds of approximately $7.2 in February 2019, received $0.6 million in grants in March 2019 and expects to receive an additional $0.4 million in grants on or prior to the first quarter of 2020, which the Company estimates should meet its planned operating requirements into the first quarter of 2020. The Company plans to raise additional capital to meet its future operating requirements until such time as the Company develops a recurring source of revenues, which is not expected for several years. The amount and timing of these capital raises is subject to general market conditions. There are no guarantees that the company will be able to complete these capital raises. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Accounting Policies [Abstract] | ||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 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”). 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, 2018 included in the Company's Annual Report on Form 10-K for the year ended December 31, 2018, filed with the SEC on March 29, 2019. Use of Estimates Preparing financial statements in conformity with accounting principles generally accepted in the United States of America 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. 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. Receivables Receivables currently consist of an R&D tax credit receivable, valued added tax (“VAT”) receivable, joint development cost receivable and a Goods and Services Tax (“GST”) receivable. The R&D tax credit receivable is recorded when R&D is incurred. At that time, the Company records a receivable for the amount of the credit it expects to receive based on the expenses incurred. The VAT receivable is recorded when the Company receives an invoice with VAT related to it. The receivable is recorded for the amount expected to be returned when the VAT tax return is filed. The joint development cost receivable is recorded when the Company incurs R&D expenses based on the amount it expects to receive as a reimbursement per the Novamune agreement (see Note 4 for detailed explanation of the agreement). The GST tax receivable is recorded when the Company receives an invoice with GST tax related to it. The collectability of these receivables are evaluated periodically based on the actual R&D credit returns submitted, the VAT returns submitted, the GST returns submitted and the amounts received from Novamune. As of March 31, 2019 and December 31, 2018, there were no trade receivables. 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. Amortization is initiated for acquired in-process research and development intangible assets when their useful lives have been determined. Acquired in-process research and development intangible assets which are determined to have had a drop in their fair value are adjusted downward and an expense recognized in research and development in the consolidated statements of operations. 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 March 31, 2019, the Company had 1,632,000 potentially issuable shares of common stock upon the exercise of stock options and 1,046,675 potentially issuable shares of common stock upon the exercise of warrants. At March 31, 2018, the Company had 1,200,000 potentially issuable shares of common stock upon the exercise of stock options, and 903,611 potentially issuable shares of common stock upon the exercise of warrants. 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, depreciation and amortization expense on research and development property and equipment, 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. 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. 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 and 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). New and Recently Issued Accounting Pronouncements During the first quarter of 2019, the Company adopted the Financial Accounting Standards Board (FASB) Accounting Standards Update (ASU) 2016-02, Leases Leases Leases In June 2018, the FASB issued ASU No. 2018-07, “Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-based Payment Accounting.” ASU 2018-07 aligns accounting for share-based payments issued to nonemployees to that of employees under the existing guidance of Topic 718, with certain exceptions. This update supersedes previous guidance for equity-based payments to nonemployees under Subtopic 505-50, “Equity – Equity-based Payments to Nonemployees.” It is effective for annual reporting periods beginning after December 15, 2018. The adoption had no impact on the Company’s consolidated statement of operations, loss per share or cash flows. Management’s Evaluation of Subsequent Events The Company evaluates events that have occurred after the balance sheet date of March 31, 2019, through the date which the financial statements are issued. | NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Use of Estimates Preparing financial statements in conformity with accounting principles generally accepted in the United States of America 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. Cash and Cash Equivalents For purposes of the statement of cash flows, the Company considers all highly liquid instruments purchased with an original maturity of three months or less to be cash equivalents. From time to time, the Company may carry cash balances at financial institutions in excess of the federally insured limit of $250,000. Receivables Receivables currently consist of an R&D tax credit receivable, valued added tax (“VAT”) receivable, joint development cost receivable and a Goods and Services tax (“GST”) receivable. The R&D tax credit receivable is recorded when R&D is incurred. At that time, the Company records a receivable for the amount of the credit it expects to receive based on the expenses incurred. The VAT receivable is recorded when the Company receives an invoice with VAT related to it. The receivable is recorded for the amount expected to be returned when the VAT tax return is filed. The joint development cost receivable is recorded when the Company incurs R&D expenses based on the amount it expects to receive as a reimbursement per the Novamune agreement (see Note 4 for detailed explanation of the agreement). The GST tax receivable is recorded when the Company receives an invoice with GST tax related to it. The collectability of these receivables are evaluated periodically based on the actual R&D credit returns submitted, the VAT returns submitted, the GST returns submitted and the amounts received from Novamune. As of December 31, 2018 and December 31, 2017, there were no trade receivables. 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. During the years ended December 31, 2018 and 2017, the Company recognized impairment related to its intangible assets of $0. 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, 2018, the Company had 1,632,000 potentially issuable shares of common stock upon the exercise of stock options and 903,611 potentially issuable shares of common stock upon the exercise of warrants. At December 31, 2017, the Company had 864,668 potentially issuable shares of common stock upon the exercise of warrants. Stock-Based Compensation The Company utilizes the Black-Scholes option pricing model to estimate the fair value of employee 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 equity instruments issued to non-employees using a fair value approach under ASC Subtopic 505-50, Equity-Based Payments to Non-Employees The Company recognizes compensation expense, on a straight-line basis over the requisite service period, which is equal to the applicable vesting period. 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, depreciation and amortization expense on research and development property and equipment, 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. 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 and 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). New and Recently Issued Accounting Pronouncements In January 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842)” (“ASU 2016-02”). This standard requires that a lessee recognize the assets and liabilities that arise from operating leases. A lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. For leases with a term of 12 months or less, a lessee is permitted to make an accounting policy election by class of underlying asset not to recognize lease assets and lease liabilities. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. ASU 2016-02 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018. The Company evaluated the effects that the adoption of this new standard will have on its financial statements and does not expect the adoption to have a material impact on its financial statements. In June 2018, the FASB issued ASU No. 2018-07, “Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-based Payment Accounting.” ASU 2018-07 aligns accounting for share-based payments issued to nonemployees to that of employees under the existing guidance of Topic 718, with certain exceptions. This update supersedes previous guidance for equity-based payments to nonemployees under Subtopic 505-50, “Equity – Equity-based Payments to Nonemployees.” It is effective for annual reporting periods beginning after December 15, 2018. The Company is currently evaluating the impact the adoption of this new standard will have on its financial statements. Subsequent Events The Company has evaluated all transactions through the financial statement issuance date for subsequent disclosure consideration. |
RESEARCH AND DEVELOPMENT ACTIVI
RESEARCH AND DEVELOPMENT ACTIVITY | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Research and Development [Abstract] | ||
RESEARCH AND DEVELOPMENT ACTIVITY | 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. INmune UK submits R&D tax credit requests annually for research and development expenses incurred, and recorded a related receivable in the amount of $295,568 and $370,900 as of March 31, 2019 and December 31, 2018, respectively. 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. INmune Australia submits R&D tax credit requests annually for research and development expenses incurred. At March 31, 2019 and December 31, 2018, the Company recorded a research and development tax credit receivable of $310,163 and $221,761, respectively, for R&D expenses incurred in Australia. During the three months ended March 31, 2019 and 2018, the Company received $152,514 and $0 of R&D tax credit reimbursements, respectively. The Company is eligible to recover all VAT for all R&D expenses paid. INmune UK recorded an other tax receivable of $126,469 and $6,282 for VAT as of March 31, 2019 and December 31, 2018, respectively. The Company is eligible to recover all GST for all R&D expenses paid. INmune Australia recorded an other tax receivable of $34,116 and $26,127 for GST as of March 31, 2019 and December 31, 2018, respectively. During the three months ended March 31, 2019 and 2018, no GST was collected. During the three months ended March 31, 2019 and 2018, the Company received $2,430 and $84,660 of VAT reimbursements, respectively. 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 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 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 Option. 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 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. Novamune Joint Development Agreement On September 3, 2016, the Company entered into a joint development agreement with Novamune, Inc. (“Novamune”) (the “Development Agreement”). Novamune is owned by a significant shareholder of the Company. Novamune had previously developed and licensed technology relating to ex-vivo activation of NK cells for the treatment of cancer and other diseases. The parties agreed to exclusively collaborate on the further development of technologies related to NK cells for therapeutic applications. The Company and Novamune agreed to share equally in the costs related to such joint development projects and agreed to jointly own any intellectual property developed by the joint projects, provided that Novamune shall have an exclusive royalty free license to use any such intellectual property relating to ex-vivo applications and the Company shall have an exclusive royalty free license to use any such intellectual property relating to in-vivo applications. As of March 31, 2019 and December 31, 2018, the Company had a joint development receivable outstanding related to Novamune’s portion of R&D costs incurred of $34,525 and $17,989, respectively. INKmune License Agreement On October 29, 2015, the Company entered into an exclusive license agreement with Immune Ventures, LLC (“Immune Ventures”), owner of all of the rights related to our principal patent (the “INKmune License Agreement”). 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 March 31, 2019): 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 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. As of March 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 our receipt of notice that we have not made a payment under the agreement, and we still do not make this payment. On July 20, 2018, the parties amended the agreement under which the Company is required achieve the following milestones: Filing of IND or equivalent, by October 29, 2019 Initiation of Phase 1 clinical or equivalent trials by October 29, 2020 Initiation of Phase II clinical trials or equivalent by October 29, 2022 Initiation of Phase III clinical trials or equivalent by October 29, 2024 Filing of NDA or equivalent by October 29, 2025 or equivalent If the Company doesn’t achieve the above milestones, it is required to negotiate in good faith with Immune Ventures to determine how it can either remedy the failure or achieve an alternate development. If the Company fails to make any required efforts or if the efforts do not remedy the situation within 60 days of written notice by Immune Ventures then Immune Ventures may provide notice to terminate the license or convert it to a non-exclusive license. University of Pittsburg License Agreement On October 3, 2017, the Company entered into an Assignment and Assumption Agreement with Immune Ventures related to intellectual property licensed from the University of Pittsburgh. Pursuant to the Assignment and Assumption Agreement (“Assignment Agreement”), Immune Ventures assigned all of its rights, obligations and liabilities under an Exclusive License Agreement between the University of Pittsburgh – Of the Commonwealth System of Higher Education (“Licensor”) and Immune Ventures to INmune Bio (“Licensee”), (the “PITT Agreement”). Consideration under the PITT Agreement includes: (i) annual maintenance fees, (ii) royalty payments based on the sale of products making use of the licensed technology, and (iii) milestone payments. Annual maintenance fees under the PITT Agreement include: $5,000 due June 26 of each year 2018-2022; $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. June 26 of each year 2018-2022 $ 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 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). Licensee may terminate the PITT Agreement upon 3 months prior written notice provided all payments under the license are current. Licensor may terminate the PITT Agreement upon written notice if: (i) Licensee defaults as to performance of material obligations which have not been cured within 60 days after receiving written notice; or (ii) Licensee ceases to carry out its business, becomes bankrupt or insolvent, applies for or consents to the appointment of a trustee, receiver or liquidator of its assets or seeks relief under any law for the aid of debtors. | NOTE 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. INmune UK submits R&D tax credit requests annually for research and development expenses incurred, and recorded a related receivable in the amount of $370,900 and $106,866 as of December 31, 2018 and December 31, 2017, respectively. 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. INmune Australia submits R&D tax credit requests annually for research and development expenses incurred. At December 31, 2018 and 2017, the Company recorded a research and development tax credit receivable of $221,761 and $0, respectively for R&D expenses incurred in Australia. During the years ended December 31, 2018 and 2017, the Company received $0 and $106,096 of R&D tax credit reimbursements, respectively. The Company is eligible to recover all VAT for all R&D expenses paid. INmune UK recorded an other tax receivable of $6,282 and $111,618 for VAT as of December 31, 2018 and December 31, 2017, respectively. The Company is eligible to recover all GST for all R&D expenses paid. INmune Australia recorded an other tax receivable of $26,127 and $0 for GST as of December 31, 2018 and December 31, 2017, respectively. During the years ended December 31, 2018 and 2017, no GST was collected. During the years ended December 31, 2018 and 2017, the Company received $187,728 and $89,329 of VAT reimbursements, respectively. 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 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 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 agreed to issue Xencor shares of the Company’s common stock equal to 19% of our fully diluted company shares the value of which are discussed below. The Company also issued warrants to Xencor which is discussed below. 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. In connection with the Xencor License Agreement, the Company entered into a stock issuance agreement with Xencor pursuant to which it issued Xencor 1,585,000 shares of its common stock with a fair value of $12,221,000 based on the discounted cash flow method of the income approach as set forth in an independent valuation report dated November 17, 2017, and 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 with a fair value of $4,193,000 based on the Black-Scholes Option Pricing Model. 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 Option. In August 2018, we 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. In connection with the stock issuance agreement, the Company, Xencor and more than 90% of shareholders as of September 30, 2017 (“Key Holders”) entered into a voting agreement. Pursuant to the voting agreement, Xencor and the Key Holders agreed to vote their respective shares to vote one individual designated by the holder of a majority of Xencor’s shares of the Company’s common stock to the Company’s board of directors. The voting agreement shall continue in full force and effect from the date hereof through the earliest of the following dates, on which date it shall terminate in its entirety: (a) the date of a qualified offering, as defined in the issuance agreement; (b) ten (10) years from the date of this Agreement; (c) the date of the closing of a qualified sale, as defined in the issuance agreement; or (d) the date as of which the parties hereto terminate this agreement by written consent of the holders of a majority of the Investor Shares. The voting agreement terminated upon completion of our IPO during February 2019. The Company recorded $16,514,000 for the acquisition of intangible assets for the in-process research and development in 2017 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 Novamune Joint Development Agreement On September 3, 2016, the Company entered into a joint development agreement with Novamune, Inc. (“Novamune”) (the “Development Agreement”). Novamune is owned by a significant shareholder of the Company. Novamune had previously developed and licensed technology relating to ex-vivo activation of NK cells for the treatment of cancer and other diseases. The parties agreed to exclusively collaborate on the further development of technologies related to NK cells for therapeutic applications. The Company and Novamune agreed to share equally in the costs related to such joint development projects and agreed to jointly own any intellectual property developed by the joint projects, provided that Novamune shall have an exclusive royalty free license to use any such intellectual property relating to ex-vivo applications and the Company shall have an exclusive royalty free license to use any such intellectual property relating to in-vivo applications. The Development Agreement is subject to Novamune or affiliates investing a total of $1,250,000 in the Company, of which $350,000 was advanced through a convertible note payable in 2016 (see further discussion in Note 5) and $900,000 was received from Luminus, a Novamune affiliate, during the year ended December 31, 2018 in exchange for the issuance of 400,000 shares of the Company’s common stock. As of December 31, 2018 and 2017, the Company had a joint development receivable outstanding related to Novamune’s portion of R&D costs incurred of $17,989 and $109,124, respectively. INKmune License Agreement On October 29, 2015, the Company entered into an exclusive license agreement with Immune Ventures, LLC (“Immune Ventures”), owner of all of the rights related to our principal patent (the “INKmune License Agreement”). 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, 2018): 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 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. As of December 31, 2018 and December 31, 2017, 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 our receipt of notice that we have not made a payment under the agreement, and we still do not make this payment. On July 20, 2018, the parties amended the agreement under which the Company is required achieve the following milestones: Filing of IND or equivalent, by October 29, 2019 Initiation of Phase 1 clinical or equivalent trials by October 29, 2020 Initiation of Phase II clinical trials or equivalent by October 29, 2022 Initiation of Phase III clinical trials or equivalent by October 29, 2024 Filing of NDA or equivalent by October 29, 2025 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”). Pursuant to the Assignment Agreement, the Company agreed to convert the amount Immune Ventures paid of $162,634 into shares of the Company’s common stock at $7.71 per share, based on the per share value of the shares issued to Xencor, for 21,094 shares for the reimbursement of amounts paid by the Assignor to the University of Pittsburgh, which the Company recorded as stock-based compensation within research and development expense. These shares were issued on December 31, 2017. 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 2018-2022; $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. June 26 of each year 2018-2022 $ 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 A Phase I study was initiated in 2018, and the Company recorded $50,000 of research and development expense during the year ended December 31, 2018 pursuant to this milestone payment schedule. 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). Licensee may terminate the PITT Agreement upon 3 months prior written notice provided all payments under the license are current. 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. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Related Party Transactions [Abstract] | ||
RELATED PARTY TRANSACTIONS | NOTE 5 – RELATED PARTY TRANSACTIONS At March 31, 2019 and December 31, 2018, the Company owed UCL Consultants Limited $9,220 and $9,020, respectively, in connection with medical research performed on behalf of the Company. UCL Consultants Limited 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. | NOTE 5 – RELATED PARTY TRANSACTIONS A significant shareholder of the Company is also the owner of various companies that conduct business with the Company, including Luminus Holdings, Inc. (“Luminus”), Novamune, and Advent Bioservices, Inc. (“Advent Bioservices”). Short-term debt – related party On May 9, 2016, the Company received cash proceeds of $350,000 from the issuance of a convertible note to Novamune that matured on August 1, 2016, with a conversion rate of $1.50 per share, and an annual interest rate of 8%. On September 3, 2016, the maturity date was extended to March 3, 2017. During the year ended December 31, 2017, the convertible note was converted into 233,345 shares of common stock of the Company. Novamune is owned by a significant shareholder of the Company. Prepaid expense – related party At December 31, 2018 and 2017, the Company had prepaid expense of $0 and $158,504, respectively, paid to UCL Consultants Limited, a wholly owned subsidiary of the University of London, in connection with medical research performed on behalf of the Company. The Company’s Chief Scientific and Manufacturing Officer is a professor at the University of London. Accounts payable and accrued liabilities – related parties At December 31, 2018 and 2017, the Company owed Advent Bioservices $0 and $173,314, respectively, for medical research provided on behalf of the Company. Advent Bioservices is owned by a significant shareholder of the Company. At December 31, 2018 and 2017, the Company owed UCL Consultants Limited $9,020 and $0, respectively, in connection with medical research performed on behalf of the Company. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | ||
COMMITMENTS AND CONTINGENCIES | NOTE 6 – COMMITMENTS AND CONTINGENCIES Litigation settlement In November 2016, an individual filed an action in Cook County, Illinois, against the Company; David J. Moss, its Chief Financial Officer, Treasurer and Secretary ; and Raymond J. Tesi, its president and Chief Executive Officer (the Company, Mr. Moss and Mr. Tesi are referred to collectively as the “Company Parties”). The action alleged claims against the Company Parties concerning payment of monies and/or securities allegedly owed. In April 2017, the Company Parties and the Claimant entered into a Settlement Agreement and Mutual General Release agreement with that individual (the “Settlement Agreement”). Pursuant to the Settlement Agreement, the Company agreed to issue 33,335 shares of the Company’s common stock valued at $50,000, based on the value of the stock of the last round of financing of $1.50 per share. The Company assessed the value of the common stock owed as of December 31, 2017, and determined that the $1.50 per share value form the most recent round of financing was still the most readily determinable value of the shares of the Company’s common stock issuable as a part of this settlement. These shares have not been issued and are subject to a restriction on transfer for a period of two years from the date the Company completes an initial public offering or otherwise becomes a public company after which the Company will deliver the shares to the Claimant. The agreement to issue the shares following the two-year restriction period was a full and complete settlement of all claims that the Claimant may have had against the Company Parties and the Cook County action was dismissed with prejudice. The obligation was recorded as common stock issuable of $50,000 as of March 31, 2019 and December 31, 2018, respectively, pending delivery of the shares to the Claimant after the restriction period expires. | NOTE 6 – COMMITMENTS AND CONTINGENCIES Litigation settlement In November 2016, an individual filed an action in Cook County, Illinois, against the Company; David J. Moss, its Chief Financial Officer, Treasurer and Secretary ; and Raymond J. Tesi, its president and Chief Executive Officer (the Company, Mr. Moss and Mr. Tesi are referred to collectively as the “Company Parties”). The action alleged claims against the Company Parties concerning payment of monies and/or securities allegedly owed. In April 2017, the Company Parties and the Claimant entered into a Settlement Agreement and Mutual General Release agreement with that individual (the “Settlement Agreement”). Pursuant to the Settlement Agreement, the Company agreed to issue 33,335 shares of the Company’s common stock valued at $50,000, based on the value of the stock of the last round of financing of $1.50 per share. The Company assessed the value of the common stock owed as of December 31, 2017, and determined that the $1.50 per share value form the most recent round of financing was still the most readily determinable value of the shares of the Company’s common stock issuable as a part of this settlement. These shares have not been issued and are subject to a restriction on transfer for a period of two years from the date the Company completes an initial public offering or otherwise becomes a public company after which the Company will deliver the shares to the Claimant. The agreement to issue the shares following the two-year restriction period was a full and complete settlement of all claims that the Claimant may have had against the Company Parties and the Cook County action was dismissed with prejudice. The obligation was recorded as common stock issuable of $50,000 as of December 31, 2018 and 2017, respectively, pending delivery of the shares to the Claimant after the restriction period expires. Trademark settlement During 2017, the Company received notice that another company had filed a trademark application with the United States Patent and Trademark Office to register a certain trademark. The Company filed an opposition in the United States Trademark Trial and Appeal Board. Subsequently, INmune and the other company entered into a settlement agreement pursuant to which the Company agreed not to oppose the other company’s trademark and the other company paid INmune cash proceeds of $150,000 in full consideration for the settlement agreement, which the Company recorded as other income in the consolidated statement of operations for the year ended December 31, 2017. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Stockholders' Equity Note [Abstract] | ||
STOCKHOLDERS' EQUITY | NOTE 7 – STOCKHOLDERS’ EQUITY The Company is authorized to issue up to 200,000,000 shares of common stock at par value $0.001 per share and 10,000,000 shares of preferred stock at a par value of $0.001 per share. During the three months ended March 31, 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). During the three months ended March 31, 2018, to complete a series of funding provided for in the Company’s joint development agreement dated September 3, 2016, the Company received $900,000 in cash from Luminus in exchange for 400,000 shares of the Company’s common stock. Luminus is owned by a significant shareholder of the Company. 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. The term of the consulting agreement is from April 24, 2018 to May 1, 2021. In consideration of the consultant’s services, the Company agreed to issue 600,000 shares of its restricted common stock, of which 200,000 shares were to be issued on May 16, 2018, 200,000 shares shall be locked up for six months after the effective date of the Company’s registration statement and 200,000 shares shall be locked up for 10 months after the date of the Company’s offering. Pursuant to this agreement, the Company recorded $4,626,000 as common stock issuable as of March 31, 2019 and December 31, 2018 for the 600,000 shares of common stock to be issued. As of March 31, 2019 and December 31, 2018, the Company recorded common stock issuable of $50,000 for 33,335 common shares related to a legal settlement valued at approximately $1.50 per share (see Note 6). Stock options A summary of stock option activity is presented in the table below for the three months ended March 31, 2019: Number of Shares Weighted- average Exercise Price Weighted-average Remaining Contractual Term (years) Aggregate Intrinsic Value Outstanding at December 31, 2018 1,632,000 $ 7.80 9.07 $ - Granted - - - - Exercised - - - - Expired/Forfeited - - - - Outstanding at March 31, 2019 1,632,000 $ 7.80 8.82 $ - Exercisable at March 31, 2019 994,000 $ 7.80 8.79 $ - During the three months ended March 31, 2019 and 2018, the Company recognized stock-based compensation expense of $974,699 and $2,461,429, respectively, related to stock options. As of March 31, 2019, there was approximately $4,067,375 of total unrecognized compensation cost related to non-vested stock options which is expected to be recognized over a weighted-average period of approximately 1.31 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. The fair value of these warrants was valued at $247,452 based on the Black-Scholes Option Pricing Model, and accounted for as an offering cost in equity. The assumptions used for these warrants consist of an exercise price of $9.60 per share, expected dividends of 0%, expected volatility of 106.85%, a risk free rate of 2.51% an expected life of 4.9 years. 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. 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, 2020. | NOTE 7 – STOCKHOLDERS’ EQUITY The Company is authorized to issue up to 200,000,000 shares of common stock at par value $0.001 per share and 10,000,000 shares of preferred stock at a par value of $0.001 per share. During the year ended December 31, 2018, to complete a series of funding provided for in the Company’s joint development agreement dated September 3, 2016, the Company received $900,000 in cash from Luminus in exchange for 400,000 shares of the Company’s common stock. Luminus is owned by a significant shareholder of the Company. On May 16, 2018, the Company entered into a consulting agreement with Pacific Seaboard Investments Ltd. for corporate governance, compliance services regarding the filing of a listing application and assist with activities related to its initial public offering. The term of the consulting agreement is from April 24, 2018 to May 1, 2021. In consideration of the consultant’s services, the Company agreed to issue 600,000 shares of its restricted common stock, of which 200,000 shares were to be issued on May 16, 2018, 200,000 shares shall be locked up for six months after the effective date of the Company’s registration statement and 200,000 shares shall be locked up for 10 months after the date of the Company’s offering. Pursuant to this agreement, the Company recorded $4,626,000 of stock-based compensation expense during the year ended December 31, 2018 for the 600,000 shares of common stock to be issued. During the year ended December 31, 2017, the Company issued 1,393,335 shares of the Company’s common stock for cash proceeds of $2,056,000 valued at approximately $1.50 per share. During the year ended December 31, 2017, the Company issued 233,345 shares of its common stock for the conversion of the full value of the Company’s outstanding convertible debt (converted at no interest) of $350,000 valued at approximately $1.50 per share. As of December 31, 2018 and 2017, the Company recorded common stock issuable of $50,000 for 33,335 common shares related to a legal settlement valued at approximately $1.50 per share (see Note 6). During 2017, in connection with the Xencor License Agreement, the Company entered into a stock issuance agreement with Xencor pursuant to which it issued Xencor 1,585,000 shares of its common stock valued in total at $12,221,000 (see Note 4). On October 3, 2017, the Company entered into an Assignment and Assumption Agreement with Immune Ventures. Pursuant to the Assignment and Assumption Agreement, Immune Ventures assigned all of its rights, obligations and liabilities under the Exclusive License Agreement between the University of Pittsburgh – Of the Commonwealth System of Higher Education and Immune Ventures. Pursuant to the Assignment and Assumption Agreement, the Company agreed to convert the amount Immune Ventures paid of $162,634 into shares of the Company’s common stock at $7.71 per share, based on the per share value of the shares issued to Xencor, for 21,094 shares for the reimbursement of amounts paid by the Assignor to the University of Pittsburgh, which the Company recorded as stock-based compensation within research and development expense. These shares were issued on December 31, 2017. Stock options During the year ended December 31, 2018, the CEO and CFO were each granted an option to purchase 400,000 shares of the Company’s common stock with a $7.80 exercise price. One-third of the options vested on January 1, 2018 and the remainder shall vest on a monthly basis over a 24-month term. The grant date fair value of these stock options was $5,115,693 based on the Black-Scholes Option Pricing model. During the year ended December 31, 2018, a board member was granted 400,000 shares of the Company’s common stock with a $7.80 exercise price. These options vest over a 24-month term. The grant date fair value of these stock options was $2,557,847 based on the Black-Scholes Option Pricing model. During April 2018, the Company granted options to purchase 108,000 shares of the Company’s common stock to each of four Board members, of which 3,000 options shall vest monthly per grant. The options have a 10-year term and a $7.80 per share exercise price and vest over a 36-month term. The grant date fair value of these stock options was $2,743,894 based on the Black-Scholes Option Pricing model. A summary of stock option activity is presented in the table below: Number of Shares Weighted- Exercise Price Weighted-average Remaining Contractual Term (years) Aggregate Intrinsic Value Outstanding at December 31, 2017 - $ - - $ - Granted 1,632,000 7.80 10.0 - Exercised - - - - Expired/Forfeited - - - - Outstanding at December 31, 2018 1,632,000 $ 7.80 9.07 $ - Exercisable at December 31, 2018 841,333 $ 7.80 9.03 $ - During the year ended December 31, 2018, the 1,632,000 options that were granted had a weighted average grant-date fair value of $6.37 per share. During the year ended December 31, 2018, the Company recognized stock-based compensation expense of $5,375,359 related to stock options. As of December 31, 2018, there was approximately $5,042,075 of total unrecognized compensation cost related to non-vested stock options which is expected to be recognized over a weighted-average period of approximately 1.51 years. The fair values of the options granted during the year ended December 31, 2018 were estimated at the date of grant using the Black-Scholes option-pricing model with the following assumptions: Market value of common stock on grant date $ 7.71 Risk free interest rate (1) 2.40% - 2.56 % Dividend yield None Volatility factor (2) 262%-267 % Weighted average expected life in years (3) 5.75 Expected forfeiture rate 0 % (1) The risk-free interest rate was determined by management using the U.S. Treasury zero-coupon yield over the contractual term of the option on date of grant. (2) Due to a lack of stock volatility history, the Company uses peer companies to estimate the volatility factor. (3) Due to a lack of stock option exercise history, the Company uses the simplified method under SAB 107 to estimate expected term. Warrants 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, with an exercise price of $1.50, maturity date of June 30, 2022, and fair value of $36,922 using the Black-Scholes option-pricing model, which were recorded as stock-based compensation. The assumptions used for these warrants consisted of an exercise price of $1.50, expected dividends of 0%, expected volatility of 106.55%, a risk free rate of 1.89% an expected life of 5 years. 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. The fair value of these warrants was valued at $4,193,000 based on the Black-Scholes Option Pricing Model. The assumptions used for these warrants consist of an exercise price of $10,000,000, expected dividends of 0%, expected volatility of 84.9%, a risk free rate of 2.04% an expected life of 6 years. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 8 – INCOME TAXES The provision for income taxes consists of the following components: December 31, 2018 December 31, 2017 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, December 31, Federal tax benefit at statutory rate $ (2,612,404 ) $ (282,704 ) Stock-based compensation 1,546,922 7,754 State income tax benefit, net of federal tax effect (418,095 ) (24,104 ) Foreign tax differential (4,019 ) 8,988 Reduction of deferred taxes due to US tax reform - 70,704 Change in valuation allowance 1,487,596 219,362 Income tax benefit $ - $ - The principal components of deferred tax assets and liabilities consist of the following at December 31, 2018 and 2017, respectively: December 31, December 31, Deferred tax assets Stock-based compensation $ 971,460 $ - Federal NOL carryforwards 355,568 69,798 Foreign NOL carryforwards 340,005 109,639 Total deferred tax assets 1,667,033 179,437 Less valuation allowance (1,667,033 ) (179,437 ) Net deferred tax assets $ - $ - New Tax reform legislation was enacted on December 22, 2017, known as the Tax Cuts and Jobs Act of 2017 (“The Act”). The Act moved from a worldwide tax system to a quasi-territorial tax system and was comprised of broad and complex changes to the U.S. tax code including, but not limited to, (1) reduced the U.S. tax rate from 35% to 21%; (2) added a deemed repatriation transition tax on certain foreign earnings and profits; (3) generally eliminated U.S. federal income taxes on dividends from foreign subsidiaries; (4) included certain income of controlled foreign companies in U.S. taxable income (“GILTI”); (5) created a new minimum tax referred to as a base erosion anti-abuse income tax; (6) limited certain U.S. Federal research based credits; and (7) eliminated the domestic manufacturing deduction. The accounting for the reduction of deferred tax asset and the tax charge for the deemed repatriation transition tax is complete as of December 31, 2018. The rate change, along with certain immaterial changes in tax basis resulting from The Act, resulted in a reduction of the Company’s deferred tax assets of approximately $71,000 and a corresponding reduction in the valuation allowance. At December 31, 2018, the Company had a federal net operating loss carryforward of approximately $1.7 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 $1,487,596 during the year ended December 31, 2018. 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, 2018, and 2017, 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. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Subsequent Events [Abstract] | ||
SUBSEQUENT EVENTS | NOTE 8 – SUBSEQUENT EVENTS During April and May 2019, the Company sold 522,212 shares of its common stock to certain investors for cash proceeds of $4,727,435 of which the Company’s CEO purchased 11,100 shares for $118,881 of cash and the Company’s CFO purchased 5,000 shares for $53,550 of cash. During April 2019, the Company received a waiver from Pacific Seaboard, whereby Pacific Seaboard permanently waived the issuance of the last 200,000 shares of the Company’s common stock required to be issued under its consulting agreement with the Company. As a result, the Company will only issue 400,000 shares of its common stock to Pacific Seaboard instead of 600,000 shares of common stock. See Note 7. | NOTE 9 – SUBSEQUENT EVENTS 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). The Company also issued the placement Agents warrants to purchase 40,833 shares of the Company’s common stock at an exercise price of $9.60 per common share, which warrants are exercisable until December 18, 2023. During February 2019, the Company was awarded a grant to receive $1,000,000 from the Alzheimer's Association to advance XPro1595, a novel therapy targeting neuroinflammation as a cause of Alzheimer’s disease. The $1,000,000 award will be paid to the Company in tranches based on the company’s Company’s achieving certain specified milestones over the course of the Phase 1 clinical trial. During March 2019, the Company received $600,000 in cash pursuant to this grant. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Accounting Policies [Abstract] | ||
Use of Estimates | Use of Estimates Preparing financial statements in conformity with accounting principles generally accepted in the United States of America 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. | Use of Estimates Preparing financial statements in conformity with accounting principles generally accepted in the United States of America 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. |
Cash and Cash Equivalents | 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. | Cash and Cash Equivalents For purposes of the statement of cash flows, the Company considers all highly liquid instruments purchased with an original maturity of three months or less to be cash equivalents. From time to time, the Company may carry cash balances at financial institutions in excess of the federally insured limit of $250,000. |
Receivables | Receivables Receivables currently consist of an R&D tax credit receivable, valued added tax (“VAT”) receivable, joint development cost receivable and a Goods and Services Tax (“GST”) receivable. The R&D tax credit receivable is recorded when R&D is incurred. At that time, the Company records a receivable for the amount of the credit it expects to receive based on the expenses incurred. The VAT receivable is recorded when the Company receives an invoice with VAT related to it. The receivable is recorded for the amount expected to be returned when the VAT tax return is filed. The joint development cost receivable is recorded when the Company incurs R&D expenses based on the amount it expects to receive as a reimbursement per the Novamune agreement (see Note 4 for detailed explanation of the agreement). The GST tax receivable is recorded when the Company receives an invoice with GST tax related to it. The collectability of these receivables are evaluated periodically based on the actual R&D credit returns submitted, the VAT returns submitted, the GST returns submitted and the amounts received from Novamune. As of March 31, 2019 and December 31, 2018, there were no trade receivables. | Receivables Receivables currently consist of an R&D tax credit receivable, valued added tax (“VAT”) receivable, joint development cost receivable and a Goods and Services tax (“GST”) receivable. The R&D tax credit receivable is recorded when R&D is incurred. At that time, the Company records a receivable for the amount of the credit it expects to receive based on the expenses incurred. The VAT receivable is recorded when the Company receives an invoice with VAT related to it. The receivable is recorded for the amount expected to be returned when the VAT tax return is filed. The joint development cost receivable is recorded when the Company incurs R&D expenses based on the amount it expects to receive as a reimbursement per the Novamune agreement (see Note 4 for detailed explanation of the agreement). The GST tax receivable is recorded when the Company receives an invoice with GST tax related to it. The collectability of these receivables are evaluated periodically based on the actual R&D credit returns submitted, the VAT returns submitted, the GST returns submitted and the amounts received from Novamune. As of December 31, 2018 and December 31, 2017, there were no trade receivables. |
Intangible Assets | Intangible Assets The Company capitalizes costs incurred in connection with in-process research and development purchased from others if the asset has alternative uses and such uses are not restricted under applicable license agreements. Amortization is initiated for acquired in-process research and development intangible assets when their useful lives have been determined. Acquired in-process research and development intangible assets which are determined to have had a drop in their fair value are adjusted downward and an expense recognized in research and development in the consolidated statements of operations. 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. | 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. During the years ended December 31, 2018 and 2017, the Company recognized impairment related to its intangible assets of $0. |
Basic and Diluted Loss per Share | Basic and Diluted Loss per Share Basic loss per share is computed by dividing net loss available to common shareholders by the weighted average number of outstanding common shares during the period. Diluted loss per share gives effect to all dilutive potential common shares outstanding during the period. Dilutive loss per share excludes all potential common shares if their effect is anti-dilutive. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. At March 31, 2019, the Company had 1,632,000 potentially issuable shares of common stock upon the exercise of stock options and 1,046,675 potentially issuable shares of common stock upon the exercise of warrants. At March 31, 2018, the Company had 1,200,000 potentially issuable shares of common stock upon the exercise of stock options, and 903,611 potentially issuable shares of common stock upon the exercise of warrants. | 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, 2018, the Company had 1,632,000 potentially issuable shares of common stock upon the exercise of stock options and 903,611 potentially issuable shares of common stock upon the exercise of warrants. At December 31, 2017, the Company had 864,668 potentially issuable shares of common stock upon the exercise of warrants. |
Stock-Based Compensation | Stock-Based Compensation The Company utilizes the Black-Scholes option pricing model to estimate the fair value of stock option awards at the date of grant, which requires the input of highly subjective assumptions, including expected volatility and expected life. Changes in these inputs and assumptions can materially affect the measure of estimated fair value of our share-based compensation. These assumptions are subjective and generally require significant analysis and judgment to develop. When estimating fair value, some of the assumptions will be based on, or determined from, external data and other assumptions may be derived from our historical experience with stock-based payment arrangements. The appropriate weight to place on historical experience is a matter of judgment, based on relevant facts and circumstances. The Company accounts for forfeitures of stock options as they occur. | Stock-Based Compensation The Company utilizes the Black-Scholes option pricing model to estimate the fair value of employee 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 equity instruments issued to non-employees using a fair value approach under ASC Subtopic 505-50, Equity-Based Payments to Non-Employees The Company recognizes compensation expense, on a straight-line basis over the requisite service period, which is equal to the applicable vesting period. |
Research and Development | Research and Development Research and development (“R&D”) costs are expensed as incurred. Research and development credits are recorded by the Company as a reduction of research and development costs. Major components of research and development costs include cash compensation, stock-based compensation, depreciation and amortization expense on research and development property and equipment, 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. | 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, depreciation and amortization expense on research and development property and equipment, 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. |
Income Taxes | Income Taxes The Company follows the liability method of accounting for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the estimated tax consequences attributable to differences between the financial statement carrying values and their respective income tax basis (temporary differences). The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. | Income Taxes The Company follows the liability method of accounting for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the estimated tax consequences attributable to differences between the financial statement carrying values and their respective income tax basis (temporary differences). The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. |
Foreign Currency Translation | Foreign Currency Translation The Company’s financial statements are presented in the U.S. dollar (“$”), which is the Company’s reporting currency, while its functional currencies are the U.S. Dollar for its U.S. based operations and 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). | 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 and 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). |
New and Recently Issued Accounting Pronouncements | New and Recently Issued Accounting Pronouncements During the first quarter of 2019, the Company adopted the Financial Accounting Standards Board (FASB) Accounting Standards Update (ASU) 2016-02, Leases Leases Leases In June 2018, the FASB issued ASU No. 2018-07, “Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-based Payment Accounting.” ASU 2018-07 aligns accounting for share-based payments issued to nonemployees to that of employees under the existing guidance of Topic 718, with certain exceptions. This update supersedes previous guidance for equity-based payments to nonemployees under Subtopic 505-50, “Equity – Equity-based Payments to Nonemployees.” It is effective for annual reporting periods beginning after December 15, 2018. The adoption had no impact on the Company’s consolidated statement of operations, loss per share or cash flows. | New and Recently Issued Accounting Pronouncements In January 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842)” (“ASU 2016-02”). This standard requires that a lessee recognize the assets and liabilities that arise from operating leases. A lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. For leases with a term of 12 months or less, a lessee is permitted to make an accounting policy election by class of underlying asset not to recognize lease assets and lease liabilities. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. ASU 2016-02 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018. The Company evaluated the effects that the adoption of this new standard will have on its financial statements and does not expect the adoption to have a material impact on its financial statements. In June 2018, the FASB issued ASU No. 2018-07, “Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-based Payment Accounting.” ASU 2018-07 aligns accounting for share-based payments issued to nonemployees to that of employees under the existing guidance of Topic 718, with certain exceptions. This update supersedes previous guidance for equity-based payments to nonemployees under Subtopic 505-50, “Equity – Equity-based Payments to Nonemployees.” It is effective for annual reporting periods beginning after December 15, 2018. The Company is currently evaluating the impact the adoption of this new standard will have on its financial statements. |
Subsequent Events | Management’s Evaluation of Subsequent Events The Company evaluates events that have occurred after the balance sheet date of March 31, 2019, through the date which the financial statements are issued. Based upon the review, the Company did not identify any subsequent events that would have required adjustment or disclosure in the financial statements. | Subsequent Events The Company has evaluated all transactions through the financial statement issuance date for subsequent disclosure consideration. |
RESEARCH AND DEVELOPMENT ACTI_2
RESEARCH AND DEVELOPMENT ACTIVITY (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Research and Development [Abstract] | ||
Schedule of milestone payments in consideration for the patent rights | 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 | 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 |
Schedule of consideration of annual maintenance fees under the PITT Agreement | June 26 of each year 2018-2022 $ 5,000 June 26 of each year 2023-2024 $ 10,000 June 26 of each year 2025 until first commercial sale $ 25,000 | June 26 of each year 2018-2022 $ 5,000 June 26 of each year 2023-2024 $ 10,000 June 26 of each year 2025 until first commercial sale $ 25,000 |
Schedule of Licensee required to make milestone payments | 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 | 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 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Stockholders' Equity Note [Abstract] | ||
Schedule of stock option activity | Number of Shares Weighted- average Exercise Price Weighted-average Remaining Contractual Term (years) Aggregate Intrinsic Value Outstanding at December 31, 2018 1,632,000 $ 7.80 9.07 $ - Granted - - - - Exercised - - - - Expired/Forfeited - - - - Outstanding at March 31, 2019 1,632,000 $ 7.80 8.82 $ - Exercisable at March 31, 2019 994,000 $ 7.80 8.79 $ - | Number of Shares Weighted- Exercise Price Weighted-average Remaining Contractual Term (years) Aggregate Intrinsic Value Outstanding at December 31, 2017 - $ - - $ - Granted 1,632,000 7.80 10.0 - Exercised - - - - Expired/Forfeited - - - - Outstanding at December 31, 2018 1,632,000 $ 7.80 9.07 $ - Exercisable at December 31, 2018 841,333 $ 7.80 9.03 $ - |
Schedule of assumptions use for fair values of the options granted | Market value of common stock on grant date $ 7.71 Risk free interest rate (1) 2.40% - 2.56 % Dividend yield None Volatility factor (2) 262%-267 % Weighted average expected life in years (3) 5.75 Expected forfeiture rate 0 % (1) The risk-free interest rate was determined by management using the U.S. Treasury zero-coupon yield over the contractual term of the option on date of grant. (2) Due to a lack of stock volatility history, the Company uses peer companies to estimate the volatility factor. (3) Due to a lack of stock option exercise history, the Company uses the simplified method under SAB 107 to estimate expected term. |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of provision for income taxes | December 31, 2018 December 31, 2017 Current expense (benefit) $ - $ - Federal - - Foreign - - Current income tax expense - - Deferred expense (benefit) - - Federal - - Foreign - - Deferred income tax - - Net deferred taxes $ - $ - |
Schedule of reconciliation of income tax benefit computed using the federal statutory income tax rate | December 31, December 31, Federal tax benefit at statutory rate $ (2,612,404 ) $ (282,704 ) Stock-based compensation 1,546,922 7,754 State income tax benefit, net of federal tax effect (418,095 ) (24,104 ) Foreign tax differential (4,019 ) 8,988 Reduction of deferred taxes due to US tax reform - 70,704 Change in valuation allowance 1,487,596 219,362 Income tax benefit $ - $ - |
Schedule of deferred tax assets and liabilities | December 31, December 31, Deferred tax assets Stock-based compensation $ 971,460 $ - Federal NOL carryforwards 355,568 69,798 Foreign NOL carryforwards 340,005 109,639 Total deferred tax assets 1,667,033 179,437 Less valuation allowance (1,667,033 ) (179,437 ) Net deferred tax assets $ - $ - |
ORGANIZATION AND BASIS OF PRE_2
ORGANIZATION AND BASIS OF PRESENTATION (Detail Textuals) - USD ($) | 1 Months Ended | |
Mar. 28, 2018 | Apr. 06, 2016 | |
INmune Bio International Ltd (England) (?INmune UK?) | ||
Organization And Basis Of Presentation [Line Items] | ||
Number of shares owned | 1,000 | |
INmune Bio Australia Pty Ltd (Australia) (?INmune Australia?) | ||
Organization And Basis Of Presentation [Line Items] | ||
Percentage of acquisition | 100.00% | |
Value of acquisition | $ 2,000 |
GOING CONCERN (Detail Textuals)
GOING CONCERN (Detail Textuals) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Going Concern [Abstract] | |||
Retained Earnings (Accumulated Deficit) | $ (15,498,913) | $ (13,597,868) | $ (1,157,845) |
Net proceeds in february 2019 | 7,300,000 | 7,200,000 | |
Proceeds from grants received in march 2019 | 600,000 | 600,000 | |
Additional grants receivable on or prior to Q1 2020 | $ 400,000 | $ 400,000 |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Detail Textuals) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Accounting Policies [Abstract] | ||||
Cash balances financial institutions in excess of federally insured | $ 250,000 | |||
Potentially issuable shares of common stock upon the exercise of stock options | 1,632,000 | 1,200,000 | 1,632,000 | |
Potentially issuable shares of common stock upon the exercise of warrants | 1,046,675 | 903,611 | 903,611 | 864,668 |
RESEARCH AND DEVELOPMENT ACTI_3
RESEARCH AND DEVELOPMENT ACTIVITY (Details) - INKmune License Agreement - Patent rights - Immune Ventures, LLC ("Immune Ventures") - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Each Phase I initiation | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Payment method of milestone payments | $ 25,000 | $ 25,000 |
Each Phase II initiation | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Payment method of milestone payments | 250,000 | 250,000 |
Each Phase III initiation | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Payment method of milestone payments | 350,000 | 350,000 |
Each NDA/EMA filing | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Payment method of milestone payments | 1,000,000 | 1,000,000 |
Each NDA/EMA awarded | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Payment method of milestone payments | $ 9,000,000 | $ 9,000,000 |
RESEARCH AND DEVELOPMENT ACTI_4
RESEARCH AND DEVELOPMENT ACTIVITY (Details 1) - University of Pittsburg License Agreement - Annual maintenance fees - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
June 26 of each year 2018-2022 | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Annual maintenance fees until first commercial sale | $ 5,000 | $ 5,000 |
June 26 of each year 2023-2024 | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Annual maintenance fees until first commercial sale | 10,000 | 10,000 |
June 26 of each year 2025 until first commercial sale | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Annual maintenance fees until first commercial sale | $ 25,000 | $ 25,000 |
RESEARCH AND DEVELOPMENT ACTI_5
RESEARCH AND DEVELOPMENT ACTIVITY (Details 2) - Immune Ventures to INmune Bio ("Licensee"), ("PITT Agreement"). - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Each Phase I initiation | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Payment method of milestone payments | $ 50,000 | $ 50,000 |
Each Phase III initiation | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Payment method of milestone payments | 500,000 | 500,000 |
First commercial sale of product making use of licensed technology | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Payment method of milestone payments | $ 1,250,000 | $ 1,250,000 |
RESEARCH AND DEVELOPMENT ACTI_6
RESEARCH AND DEVELOPMENT ACTIVITY (Detail Textuals) - USD ($) | Dec. 03, 2017 | Oct. 03, 2017 | Aug. 31, 2018 | Nov. 17, 2017 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Sep. 03, 2016 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
VAT receivable | $ 187,728 | $ 89,329 | |||||||
Common stock issued (in shares) | 9,740,261 | 8,719,441 | 8,319,441 | ||||||
Issuance of common stock | $ 7,251,142 | $ 900,000 | $ 900,000 | $ 2,056,000 | |||||
Xencor, Inc. License Agreement | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Non Refundable Fee | $ 100,000 | $ 100,000 | |||||||
Percentage of common stock equal to fully diluted shares | 19.00% | ||||||||
Common stock issued (in shares) | 1,585,000 | 1,585,000 | |||||||
Common stock with fair value on discounted cash flow | $ 12,221,000 | $ 12,221,000 | |||||||
Percentage of fully vested warrants to purchase an additional number of shares of common stock | $ 4,193,000 | ||||||||
Common stock equal to fully diluted shares to purchase with fair value | 10.00% | 10.00% | |||||||
Fair value of warrants | $ 4,193,000 | ||||||||
Warrant exercise price based on valuation of the company | $ 100,000,000 | $ 4,193,000 | |||||||
Expiry date of warrants exercise price based on a valuation | October 3, 2023 | ||||||||
Aggregate purchase price for exercise of option pro-rated for any partial exercise | $ 10,000,000 | ||||||||
Percentage of stock issuance agreement | 90.00% | ||||||||
In-process research and development | 16,514,000 | 16,514,000 | |||||||
Novamune Joint Development Agreement [Member] | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Development agreement to affiliates investing | $ 1,250,000 | ||||||||
Convertible note payable | $ 350,000 | ||||||||
Affiliate received from Luminus, a Novamune | 900,000 | ||||||||
Issuance of common stock | 400,000 | ||||||||
Joint Development Receivable Outstanding | 34,525 | 17,989 | 109,124 | ||||||
R&D tax credit | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Research and develpment tax credit receivable | 0 | 106,096 | |||||||
Reimbursements of research and develpment tax credit | 152,514 | 0 | |||||||
Value Added Tax Reimbursements | 2,430 | $ 84,660 | |||||||
R&D tax credit | UNITED KINGDOM | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Research and develpment tax credit receivable | 295,568 | 370,900 | 106,866 | ||||||
VAT receivable | 126,469 | 6,282 | 111,618 | ||||||
R&D tax credit | AUSTRALIA | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Research and develpment tax credit receivable | 310,163 | 221,761 | 0 | ||||||
VAT receivable | $ 34,116 | 26,127 | |||||||
Goods and Services Tax ("GST") receivable | $ 26,127 | $ 0 |
RESEARCH AND DEVELOPMENT ACTI_7
RESEARCH AND DEVELOPMENT ACTIVITY (Detail Textuals 1) - USD ($) | Oct. 03, 2017 | Mar. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Oct. 29, 2015 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | ||
INKmune License Agreement | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Percentage of licensor royalty patent grant | 1.00% | ||||
University of Pittsburg License Agreement | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Value of common stock issue | $ 162,634 | ||||
Common stock, par value (in dollars per share) | $ 7.71 | ||||
Percentage of net sales to pay royalties | 2.50% | ||||
University of Pittsburg License Agreement | June 26 of each year 2018-2022 | Annual maintenance fees | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Long-term Commercial Paper | $ 5,000 | $ 5,000 | |||
University of Pittsburg License Agreement | June 26 of each year 2023-2024 | Annual maintenance fees | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Long-term Commercial Paper | 10,000 | 10,000 | |||
University of Pittsburg License Agreement | June 26 of each year 2025 until first commercial sale | Annual maintenance fees | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Long-term Commercial Paper | $ 25,000 | 25,000 | |||
Immune Ventures to INmune Bio ("Licensee"), ("PITT Agreement"). | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Agreement expiry period | 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). | ||||
Immune Ventures to INmune Bio ("Licensee"), ("PITT Agreement"). | Each Phase I initiation | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Revenue Recognition, Milestone Method, Revenue Recognized | $ 50,000 | $ 50,000 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Detail Textuals) - USD ($) | May 09, 2016 | Dec. 31, 2017 | Mar. 31, 2019 | Dec. 31, 2018 |
Related Party Transaction [Line Items] | ||||
Conversion of related party debt to common stock | 233,345 | |||
Value of common stock issued for convertible debt | $ 350,000 | |||
Prepaid expenses - related party | 158,504 | |||
Accounts payable and accrued liabilities - related parties | 183,460 | $ 9,220 | $ 9,020 | |
Novamune, Inc | ||||
Related Party Transaction [Line Items] | ||||
Value of common stock issued for convertible debt | $ 350,000 | |||
Debt instrument conversion rate | $ 1.50 | |||
Percentage of annual interest rate | 8.00% | |||
Advent Bioservices, Inc. | ||||
Related Party Transaction [Line Items] | ||||
Accounts payable and accrued liabilities - related parties | 173,314 | 0 | ||
Ucl Consultants Limited | ||||
Related Party Transaction [Line Items] | ||||
Accounts payable and accrued liabilities - related parties | $ 0 | $ 9,020 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Detail Textuals) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Dec. 31, 2017 | Dec. 31, 2018 | |
Loss Contingencies [Line Items] | |||
Common stock issuable | $ 4,676,000 | $ 50,000 | $ 4,676,000 |
Share Price | $ 1.50 | ||
Common stock issued | $ 9,740 | $ 8,319 | $ 8,719 |
Gain on legal settlements | $ 150,000 | ||
Litigation settlement | |||
Loss Contingencies [Line Items] | |||
Number of common stock issuable | 33,335 | 33,335 | 33,335 |
Common stock issuable | $ 50,000 | $ 50,000 | $ 50,000 |
Share Price | $ 1.50 | $ 1.50 | $ 1.50 |
Common stock issued | $ 50,000 | $ 50,000 | $ 50,000 |
Gain on legal settlements | $ 150,000 | ||
Shares restriction period | 2 years |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Number ofShares | ||
Outstanding at December 31, 2017 | 1,632,000 | 0 |
Granted | 0 | 1,632,000 |
Exercised | 0 | 0 |
Expired/Forfeited | 0 | 0 |
Outstanding at December 31, 2018 | 1,632,000 | 1,632,000 |
Exercisable at December 31, 2018 | 994,000 | 841,333 |
Weighted-average Exercise Price | ||
Outstanding at December 31, 2017 | $ 7.80 | $ 0 |
Granted | 0 | 7.80 |
Exercised | 0 | 0 |
Expired/Forfeited | 0 | 0 |
Outstanding at December 31, 2018 | 7.80 | 7.80 |
Exercisable at December 31, 2018 | $ 7.80 | $ 7.80 |
Weighted-average Remaining Contractual Term (years), Granted | 10 years | |
Weighted-average Remaining Contractual Term (years) | 8 years 9 months 26 days | 9 months 26 days |
Weighted-average Remaining Contractual Term (years), Exercisable | 8 years 9 months 15 days | 9 years 11 days |
Aggregate Intrinsic Value | $ 0 | $ 0 |
STOCKHOLDERS' EQUITY (Details 1
STOCKHOLDERS' EQUITY (Details 1) | 12 Months Ended | |
Dec. 31, 2018$ / shares | ||
Stockholders' Equity Note [Abstract] | ||
Market value of common stock on grant date | $ 7.71 | |
Risk free interest rate, minimum | 2.40% | [1] |
Risk free interest rate, maximum | 2.56% | [1] |
Dividend yield | 0.00% | |
Volatility factor, minimum | 262.00% | [2] |
Volatility factor, maximum | 267.00% | [2] |
Weighted average expected life in years | 5 years 9 months | [3] |
Expected forfeiture rate | 0.00% | |
[1] | The risk-free interest rate was determined by management using the U.S. Treasury zero-coupon yield over the contractual term of the option on date of grant. | |
[2] | Due to a lack of stock volatility history, the Company uses peer companies to estimate the volatility factor. | |
[3] | Due to a lack of stock option exercise history, the Company uses the simplified method under SAB 107 to estimate expected term. |
STOCKHOLDERS' EQUITY (Detail Te
STOCKHOLDERS' EQUITY (Detail Textuals) - USD ($) | Oct. 03, 2017 | May 16, 2018 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | 200,000,000 | |||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | |||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |||
Number of shares issuance | 400,000 | 1,393,335 | ||||
Value of shares issuance | $ 900,000 | $ 900,000 | $ 2,056,000 | |||
Value of shares issued for consideration | 4,626,000 | |||||
Price per share | $ 1.50 | |||||
Number of common stock issued for convertible debt | 233,345 | |||||
Value of common stock issued for convertible debt | $ 350,000 | |||||
Per share price | $ 1.50 | |||||
Common stock issuable | $ 4,676,000 | $ 4,676,000 | $ 50,000 | |||
Adjustments to Additional Paid in Capital, Share-based Compensation, Requisite Service Period Recognition | $ 974,699 | $ 2,461,429 | $ 199,556 | |||
IPO [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of common stock sold | 1,020,820 | |||||
Gross proceeds from common stock sold | $ 8,166,560 | |||||
Net proceeds from common stock sold | 7,251,142 | |||||
Litigation settlement | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Per share price | $ 1.50 | $ 1.50 | $ 1.50 | |||
Common stock issuable | $ 50,000 | $ 50,000 | $ 50,000 | |||
Number Of Common Stock Issuable | 33,335 | 33,335 | 33,335 | |||
Employee Stock Option [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Adjustments to Additional Paid in Capital, Share-based Compensation, Requisite Service Period Recognition | $ 974,699 | $ 2,461,429 | $ 5,375,359 | |||
Total unrecognized compensation cost related to non-vested stock | $ 4,067,375 | $ 5,042,075 | ||||
Unrecognized compensation weighted-average period related to non-vested stock | 1 year 3 months 22 days | 1 year 6 months 4 days | ||||
Luminus Holdings, Inc. | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares issuance | 400,000 | 400,000 | ||||
Value of shares issuance | $ 900,000 | $ 900,000 | ||||
Stock-based compensation expense | $ 4,626,000 | |||||
Number of shares issued for compensation expense | 600,000 | |||||
Pacific Seaboard Investments Ltd. | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Term of consulting agreement | from April 24, 2018 to May 1, 2021 | |||||
Pacific Seaboard Investments Ltd. | Consulting agreement | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Term of consulting agreement | from April 24, 2018 to May 1, 2021 | |||||
Value of shares issued for consideration | $ 4,626,000 | |||||
Number of shares issued for consideration | 600,000 | |||||
Pacific Seaboard Investments Ltd. | Restricted common stock | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares issuable | 200,000 | |||||
Number of shares shall be locked up for six months | 200,000 | |||||
Number of shares shall be locked up for 10 months | 200,000 | |||||
Pacific Seaboard Investments Ltd. | Restricted common stock | Consulting agreement | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares issuable | 200,000 | |||||
Number of shares shall be locked up for six months | 200,000 | |||||
Number of shares shall be locked up for 10 months | 200,000 | |||||
Xencor, Inc. | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares issuance | 21,094 | 1,585,000 | ||||
Value of shares issuance | $ 162,634 | $ 12,221,000 | ||||
Per share price | $ 7.71 |
STOCKHOLDERS' EQUITY (Detail _2
STOCKHOLDERS' EQUITY (Detail Textuals 1) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Apr. 30, 2018 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares granted | 0 | 1,632,000 | |||
Exercise price | $ 0 | $ 7.80 | |||
Weighted average grant-date fair value | $ 7.71 | ||||
Stock-based compensation | $ 974,699 | $ 2,461,429 | $ 199,556 | ||
Stock options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares granted | 108,000 | 1,632,000 | |||
Exercise price | $ 7.80 | $ 6.37 | |||
Vesting terms | 36 months | ||||
Fair value of these stock options granted | $ 2,743,894 | ||||
Stock options terms | 10 years | ||||
Stock Options Expected To Vest Monthly Per Grant | 3,000 | ||||
Weighted average grant-date fair value | $ 6.37 | $ 7.71 | |||
Stock-based compensation | 974,699 | $ 2,461,429 | $ 5,375,359 | ||
Total unrecognized compensation cost related to non-vested stock | $ 4,067,375 | $ 5,042,075 | |||
Unrecognized compensation weighted-average period related to non-vested stock | 1 year 3 months 22 days | 1 year 6 months 4 days | |||
CEO and CFO | Stock options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares granted | 400,000 | ||||
Exercise price | $ 7.80 | ||||
Options Vested Date | Jan. 1, 2018 | ||||
Vesting terms | 24 months | ||||
Vesting ratio | One-third | ||||
Fair value of these stock options granted | $ 5,115,693 | ||||
Board | Stock options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares granted | 400,000 | ||||
Exercise price | $ 7.80 | ||||
Vesting terms | 24 months | ||||
Fair value of these stock options granted | $ 2,557,847 |
STOCKHOLDERS' EQUITY (Detail _3
STOCKHOLDERS' EQUITY (Detail Textuals 2) | Oct. 03, 2017USD ($) | Nov. 17, 2017 | Dec. 31, 2018USD ($)$ / shares | Feb. 28, 2019USD ($)Percent$ / shares | Jun. 30, 2017USD ($)$ / sharesshares |
Xencor, Inc. License Agreement | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Fair value of fair warrants | $ | $ 4,193,000 | ||||
Common stock equal to fully diluted shares to purchase with fair value | 10.00% | 10.00% | |||
Expected dividends | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Warrants measurement input | 0 | 0 | |||
Expected volatility | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Warrants measurement input | 84.9 | 106.55 | |||
Risk free rate | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Warrants measurement input | 2.04 | 1.89 | |||
Expected life | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Expected life | 6 years | 5 years | |||
Warrants | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of warrants issued | shares | 31,667 | ||||
Number of fully vested warrants issued | shares | 31,667 | ||||
Fair value of fair warrants | $ | $ 4,193,000 | $ 36,922 | |||
Warrants maturity date | Jun. 30, 2022 | ||||
Exercise price of warrants | $ / shares | $ 10,000,000 | $ 1.50 | |||
Common stock equal to fully diluted shares to purchase with fair value | 10.00% | ||||
Warrants | IPO [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Fair value of fair warrants | $ | $ 247,452 | ||||
Warrants maturity date | Dec. 19, 2023 | ||||
Exercise price of warrants | $ / shares | $ 9.60 | ||||
Warrants | Expected dividends | IPO [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Warrants measurement input | Percent | 0 | ||||
Warrants | Expected volatility | IPO [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Warrants measurement input | Percent | 106.85 | ||||
Warrants | Risk free rate | IPO [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Warrants measurement input | Percent | 2.51 | ||||
Warrants | Expected life | IPO [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Expected life | 4 years 10 months 24 days |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Current expense (benefit) | ||
Federal | $ 0 | $ 0 |
Foreign | 0 | 0 |
Current income tax expense | 0 | 0 |
Deferred expense (benefit) | ||
Federal | 0 | 0 |
Foreign | 0 | 0 |
Deferred income tax | 0 | 0 |
Net deferred taxes | $ 0 | $ 0 |
INCOME TAXES (Details 1)
INCOME TAXES (Details 1) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Federal tax benefit at statutory rate | $ (2,612,404) | $ (282,704) |
Stock-based compensation | 1,546,922 | 7,754 |
State income tax benefit, net of federal tax effect | (418,095) | (24,104) |
Foreign tax differential | (4,019) | 8,988 |
Reduction of deferred taxes due to US tax reform | 0 | 70,704 |
Change in valuation allowance | 1,487,596 | 219,362 |
Income tax benefit | $ 0 | $ 0 |
INCOME TAXES (Details 2)
INCOME TAXES (Details 2) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred tax assets | ||
Stock-based compensation | $ 971,460 | $ 0 |
Federal NOL carryforwards | 355,568 | 69,798 |
Foreign NOL carryforwards | 340,005 | 109,639 |
Total deferred tax assets | 1,667,033 | 179,437 |
Less valuation allowance | (1,667,033) | (179,437) |
Net deferred tax assets | $ 0 | $ 0 |
INCOME TAXES (Detail Textuals)
INCOME TAXES (Detail Textuals) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
U.S. tax rate | 21.00% | 35.00% |
Amount of reduction in deferred tax assets | $ 71,000 | |
Federal net operating loss carryforward | 1,700,000 | |
Change in valuation allowance | $ 1,487,596 | $ 219,362 |
SUBSEQUENT EVENTS (Detail Textu
SUBSEQUENT EVENTS (Detail Textuals) - USD ($) | 1 Months Ended | 2 Months Ended | 3 Months Ended | 12 Months Ended | ||
Apr. 30, 2019 | Feb. 28, 2019 | May 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Subsidiary, Sale of Stock [Line Items] | ||||||
Stock Issued During Period, Shares, New Issues | 400,000 | 1,393,335 | ||||
Stock Issued During Period, Value, New Issues | $ 900,000 | $ 900,000 | $ 2,056,000 | |||
Initial public offering | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Number of common stock sold | 1,020,820 | |||||
Subsequent event | Alzheimer's Association | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Amount of awards granted | $ 1,000,000 | |||||
Cash received form awards granted | $ 600,000 | |||||
Subsequent event | Initial public offering | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Number of common stock sold | 1,020,820 | |||||
Gross proceeds from initial public offering | $ 8,166,560 | |||||
Net proceeds from initial public offering | $ 7,251,142 | |||||
Subsequent event | Placement agents | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Number of common stock called by warrants | 40,833 | |||||
Exercise price of warrants | $ 9.60 | |||||
Subsequent event | Investors | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Stock Issued During Period, Shares, New Issues | 522,212 | |||||
Proceeds from issuance or sale of equity | $ 4,727,435 | |||||
Subsequent event | Chief Executive Officer [Member] | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Stock Issued During Period, Shares, New Issues | 11,100 | |||||
Stock Issued During Period, Value, New Issues | $ 118,881 | |||||
Subsequent event | Chief Financial Officer [Member] | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Stock Issued During Period, Shares, New Issues | 5,000 | |||||
Stock Issued During Period, Value, New Issues | $ 53,550 | |||||
Subsequent event | Consulting agreement | Pacific Seaboard | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Number of shares waived | 200,000 | |||||
Stock Issued During Period, Shares, New Issues | 400,000 |