Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2022 | May 05, 2022 | |
Document Information Line Items | ||
Entity Registrant Name | Inmune Bio, Inc. | |
Trading Symbol | INMB | |
Document Type | 10-Q | |
Current Fiscal Year End Date | --12-31 | |
Entity Common Stock, Shares Outstanding | 17,945,995 | |
Amendment Flag | false | |
Entity Central Index Key | 0001711754 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Period End Date | Mar. 31, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Shell Company | false | |
Entity Ex Transition Period | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Incorporation, State or Country Code | NV | |
Entity Tax Identification Number | 47-5205835 | |
Entity Address, Address Line One | 225 NE Mizner Blvd | |
Entity Address, Address Line Two | Suite 640 | |
Entity Address, City or Town | Boca Raton | |
Entity Address, State or Province | FL | |
Entity Address, Postal Zip Code | 33432 | |
City Area Code | 858 | |
Local Phone Number | 964-3720 | |
Entity Interactive Data Current | Yes | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Security Exchange Name | NASDAQ | |
Entity File Number | 001-38793 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
CURRENT ASSETS | ||
Cash and cash equivalents | $ 66,729 | $ 74,810 |
Research and development tax credit receivable | 5,149 | 4,913 |
Other tax receivable | 499 | 591 |
Prepaid expenses | 4,668 | 2,278 |
Prepaid expenses – related party | 14 | 14 |
TOTAL CURRENT ASSETS | 77,059 | 82,606 |
Operating lease – right of use asset – related party | 681 | 726 |
Other assets | 99 | 99 |
Acquired in-process research and development intangible assets | 16,514 | 16,514 |
TOTAL ASSETS | 94,353 | 99,945 |
CURRENT LIABILITIES | ||
Accounts payable and accrued liabilities | 2,551 | 3,733 |
Accounts payable and accrued liabilities – related parties | 9 | 80 |
Deferred liabilities | 584 | 474 |
Operating lease, current liabilities | 82 | 72 |
TOTAL CURRENT LIABILITIES | 3,226 | 4,359 |
Long-term debt, less debt discount | 14,514 | 14,458 |
Long-term operating lease liabilities | 684 | 704 |
Accrued liability – long-term | 287 | 199 |
TOTAL LIABILITIES | 18,711 | 19,720 |
COMMITMENTS AND CONTINGENCIES | ||
STOCKHOLDERS’ EQUITY | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized, 0 shares issued and outstanding | ||
Common stock, $0.001 par value, 200,000,000 shares authorized, 17,945,995 and 17,843,303 shares issued and outstanding, respectively | 18 | 18 |
Additional paid-in capital | 146,186 | 143,921 |
Accumulated other comprehensive income | 56 | 1 |
Accumulated deficit | (70,618) | (63,715) |
TOTAL STOCKHOLDERS’ EQUITY | 75,642 | 80,225 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 94,353 | $ 99,945 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 17,945,995 | 17,843,303 |
Common stock, shares outstanding | 17,945,995 | 17,843,303 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Income Statement [Abstract] | ||
REVENUE | $ 163 | $ 4 |
OPERATING EXPENSES | ||
General and administrative | 2,332 | 2,061 |
Research and development | 4,309 | 2,491 |
Total operating expenses | 6,641 | 4,552 |
LOSS FROM OPERATIONS | (6,478) | (4,548) |
OTHER EXPENSE | ||
Other expense, net | (425) | (8) |
Total other expense, net | (425) | (8) |
NET LOSS | $ (6,903) | $ (4,556) |
Net loss per common share – basic and diluted (in Dollars per share) | $ (0.39) | $ (0.32) |
Weighted average number of common shares outstanding – basic and diluted (in Shares) | 17,870,285 | 14,322,659 |
COMPREHENSIVE LOSS | ||
Net loss | $ (6,903) | $ (4,556) |
Other comprehensive income – foreign currency translation | 55 | 1 |
Total comprehensive loss | $ (6,848) | $ (4,555) |
Condensed Consolidated Statem_2
Condensed Consolidated Statement of Changes in Stockholders’ Equity (Unaudited) - USD ($) $ in Thousands | Common Stock | Additional Additional Capital | Accumulated Accumulated Comprehensive Income | Accumulated Deficit | Total |
Balance at Dec. 31, 2020 | $ 13 | $ 72,105 | $ 11 | $ (33,375) | $ 38,754 |
Balance (in Shares) at Dec. 31, 2020 | 13,481,283 | ||||
Issuance of common stock for cash | $ 2 | 28,444 | 28,446 | ||
Issuance of common stock for cash (in Shares) | 1,439,480 | ||||
Exercise of warrants for cash | 18 | 18 | |||
Exercise of warrants for cash (in Shares) | 11,875 | ||||
Stock-based compensation | 899 | 899 | |||
Gain on foreign currency translation | 1 | 1 | |||
Net loss | (4,556) | (4,556) | |||
Balance at Mar. 31, 2021 | $ 15 | 101,466 | 12 | (37,931) | 63,562 |
Balance (in Shares) at Mar. 31, 2021 | 14,932,638 | ||||
Balance at Dec. 31, 2021 | $ 18 | 143,921 | 1 | (63,715) | 80,225 |
Balance (in Shares) at Dec. 31, 2021 | 17,843,303 | ||||
Issuance of common stock for cash | 699 | 699 | |||
Issuance of common stock for cash (in Shares) | 82,900 | ||||
Exercise of warrants for cash | 30 | 30 | |||
Exercise of warrants for cash (in Shares) | 19,792 | ||||
Stock-based compensation | 1,536 | 1,536 | |||
Gain on foreign currency translation | 55 | 55 | |||
Net loss | (6,903) | (6,903) | |||
Balance at Mar. 31, 2022 | $ 18 | $ 146,186 | $ 56 | $ (70,618) | $ 75,642 |
Balance (in Shares) at Mar. 31, 2022 | 17,945,995 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (6,903) | $ (4,556) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 1,536 | 899 |
Accretion of debt discount | 56 | |
Changes in operating assets and liabilities: | ||
Research and development tax credit receivable | (236) | (504) |
Other tax receivable | 92 | (41) |
Prepaid expenses | (2,390) | (1,294) |
Prepaid expenses – related party | (15) | |
Accounts payable and accrued liabilities | (1,182) | 54 |
Accounts payable and accrued liabilities – related parties | (71) | (24) |
Deferred liabilities | 110 | 401 |
Accrued liability – long-term | 88 | |
Operating lease liabilities | 35 | (12) |
Net cash used in operating activities | (8,865) | (5,092) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Net proceeds from sale of common stock | 699 | 28,446 |
Net proceeds from the exercise of warrants | 30 | 18 |
Net cash provided by financing activities | 729 | 28,464 |
Impact on cash from foreign currency translation | 55 | 1 |
NET (DECREASE) INCREASE IN CASH | (8,081) | 23,373 |
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 74,810 | 21,967 |
CASH AND CASH EQUIVALENTS AT END OF PERIOD | 66,729 | 45,340 |
SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | ||
Cash paid for income taxes | ||
Cash paid for interest expense | $ 291 |
Organization and Description of
Organization and Description of Business | 3 Months Ended |
Mar. 31, 2022 | |
Organization and Basis of Presentation [Abstract] | |
ORGANIZATION AND DESCRIPTION OF BUSINESS | NOTE 1 INmune Bio, Inc. (the “Company” or “INmune Bio”) was organized in the State of Nevada on September 25, 2015, and is a clinical stage biotechnology pharmaceutical company focused on developing and commercializing its product candidates to treat diseases where the innate immune system is not functioning normally and contributing to the patient’s disease. INmune Bio has two product platforms. The DN-TNF product platform (XPro1595, XPro™, pegipanermin |
Liquidity
Liquidity | 3 Months Ended |
Mar. 31, 2022 | |
Liquidity Disclosure [Abstract] | |
LIQUIDITY | NOTE 2 As of March 31, 2022, the Company had an accumulated deficit of $70,618,000 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. To meet its current and future obligations the Company has taken the following steps to capitalize the business and achieve its business plan: ● During March 2022, the Company sold 82,900 shares of common stock to certain officers and directors of the Company at a price per share of $8.43 (which was the closing price of the Company’s common stock on March 22, 2022) ● During July 2021, the Company completed a registered direct public offering in which it sold 1,818,182 shares of common stock to investors for estimated net proceeds of $36.9 million. ● During June 2021, the Company entered into a loan and security agreement and drew down a $15.0 million term loan. ● During March 2021, the Company entered into a sales agreement with BTIG, LLC (“BTIG”), as agent, to establish an At-The-Market (“ATM”) offering of up to $45 million of common stock (the “2021 ATM”), subject to certain limitations on the amount of common stock that may be offered and sold by the Company set forth in the sales agreement. The Company is required to pay BTIG a commission of 3% of the gross proceeds from the sale of shares. The Company has sold 713,192 shares of its common stock at an average price of $21.73 through the 2021 ATM for net proceeds of $14.9 million. Although it is difficult to predict the Company’s liquidity requirements, as of March 31, 2022, and based upon the Company’s current operating plan, the Company believes that it will have sufficient cash to meet its projected operating requirements for at least the next 12 months following the filing date of this Quarterly Report on Form 10-Q based on the balance of cash available as of March 31, 2022. The Company anticipates that it will continue to incur net losses for the foreseeable future as it continues the development of its clinical drug candidates and preclinical programs and incurs additional costs associated with being a public company. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 3 Basis of Presentation The accompanying financial statements are presented in U.S. dollars and have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”), and pursuant to the accounting and disclosure rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The consolidated financial statements include the accounts of INmune Bio, Inc. and its subsidiaries. Intercompany transactions and balances have been eliminated. In the opinion of management, the interim financial information includes all normal recurring adjustments necessary for a fair statement of the results for the interim periods. Risks and Uncertainties The Company is subject to risks and uncertainties as a result of the COVID-19 pandemic. The extent of the impact of the COVID-19 pandemic on the Company’s business is highly uncertain and difficult to predict. Also, economies worldwide have also been negatively impacted by the COVID-19 pandemic, however policymakers around the globe have responded with fiscal policy actions to support the healthcare industry and economy as a whole. The magnitude and overall effectiveness of these actions remain uncertain. In addition, the Company’s clinical trials have been affected by and may continue to be affected by the COVID-19 pandemic. Clinical site initiation and patient enrollment have and may continue to be delayed due to prioritization of hospital resources toward the COVID-19 pandemic. Some patients have not and others may not be able to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services. Similarly, the ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19, may adversely impact the Company’s clinical trial operations. The severity of the impact of the COVID-19 pandemic on the Company’s business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic and the extent and severity of the impact on the Company’s service providers, suppliers, contract research organizations (“CROs”) and the Company’s clinical trials, all of which are uncertain and cannot be predicted. As of the date of issuance of Company’s financial statements, the extent to which the COVID-19 pandemic may materially impact the Company’s financial condition, liquidity or results of operations is uncertain. Use of Estimates Preparing financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses. 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. Research and Development Tax Incentive Receivable The Company, through its wholly-owned subsidiary in Australia (“AUS”), participates in the Australian research and development tax incentive program, such that a percentage of our qualifying research and development expenditures are reimbursed by the Australian government, and such incentives are reflected as a reduction of research and development expense. The Australian research and development tax incentive is recognized when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the amount of the consideration can be reliably measured. At each period end, management estimates the reimbursement available to the Company based on available information at the time. The Company, through its wholly-owned subsidiary in the United Kingdom (“UK”), participates in the research and development program provided by the United Kingdom tax relief program, such that a percentage of our qualifying research and development expenditures are reimbursed by the United Kingdom government, and such incentives are reflected as a reduction of research and development expense. The United Kingdom research and development tax incentive is recognized when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the amount of the consideration can be reliably measured. At each period end, management estimates the reimbursement available to the Company based on available information at the time. Intangible Assets The Company capitalizes costs incurred in connection with in-process research and development purchased from others if the asset has alternative uses and such uses are not restricted under applicable license agreements; patent applications (principally legal fees), patent purchases, and trademarks related to its cell line as intangible assets. Acquired in-process research and development costs that do not have alternative uses are expensed as incurred. When the assets are determined to have a finite life (upon completion of the development of the in-process research and development for its DN-TNF platform), the useful life will be determined and the in-process research and development intangible assets will be amortized. During the fourth quarter and if business factors indicate more frequently, the Company performs an assessment of the qualitative factors affecting the fair value of our in-process research and development. If the qualitative assessment suggests that impairment is more likely than not, a quantitative analysis is performed. The quantitative analysis involves a comparison of the fair value of the in-process research and development with the carrying amount. If the carrying amount of the in-process research and development exceeds its fair value, an impairment loss is recognized in an amount equal to that excess. 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, 2022 and 2021, the Company had potentially issuable shares as follows: March 31, 2022 2021 Stock options 4,859,333 3,655,549 Warrants 80,221 2,126,047 Total 4,939,554 5,781,596 Revenue Recognition The Company recognizes revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. The Company recognizes revenue following the five-step model prescribed under ASC Topic 606: (1) identify contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenues when (or as) the Company satisfies the performance obligations. The Company records the expenses related to revenue in research and development expense, in the periods such expenses were incurred. The Company records deferred revenues when cash payments are received or due in advance of performance, including amounts which are refundable. Stock-Based Compensation The Company utilizes the Black-Scholes option pricing model to estimate the fair value of stock option awards at the date of grant, which requires the input of highly subjective assumptions, including expected volatility and expected life. Changes in these inputs and assumptions can materially affect the measure of estimated fair value of our share-based compensation. These assumptions are subjective and generally require significant analysis and judgment to develop. When estimating fair value, some of the assumptions will be based on, or determined from, external data and other assumptions may be derived from our historical experience with stock-based payment arrangements. The appropriate weight to place on historical experience is a matter of judgment, based on relevant facts and circumstances. The Company accounts for forfeitures of stock options as they occur. Research and Development Research and development (“R&D”) costs are expensed as incurred. Research and development credits are recorded by the Company as a reduction of research and development costs. Major components of research and development costs include cash compensation, stock-based compensation, costs of preclinical studies, clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf. The Company recognizes grants as contra research and development expense in the consolidated statement of operations on a systematic basis over the periods in which the entity recognizes as expenses the related costs for which the grants are intended to compensate. Income Taxes The Company follows the liability method of accounting for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the estimated tax consequences attributable to differences between the financial statement carrying values and their respective income tax basis (temporary differences). The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Foreign Currency Translation The Company’s financial statements are presented in the U.S. dollar (“$”), which is the Company’s reporting currency, while its functional currencies are the U.S. Dollar for its U.S. based operations, British Pound (“GBP”) for its United Kingdom-based operations and Australian Dollars (“AUD”) for its Australian-based operations. All assets and liabilities are translated at the exchange rate on the balance sheet date, stockholders’ equity is translated at historical rates and statement of operations items are translated at the weighted average exchange rate for the period. The resulting translation adjustments are reported under other comprehensive income. Gains and losses resulting from the translations of foreign currency transactions and balances are reflected in the statement of operations and comprehensive income (loss). Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments, as clarified in subsequent amendments. ASU 2016-13 changes the impairment model for certain financial instruments. The new model is a forward-looking expected loss model and will apply to financial assets subject to credit losses and measured at amortized cost and certain off-balance sheet credit exposures. This includes loans, held-to-maturity debt securities, loan commitments, financial guarantees and net investments in leases, as well as trade receivables. For available-for-sale debt securities with unrealized losses, credit losses will be measured in a manner similar to today, except that the losses will be recognized as allowances rather than reductions in the amortized cost of the securities. In October 2019, the FASB voted to delay the effective date of this standard. Topic 326 will be effective for the Company on January 1, 2023. Early adoption is permitted. The Company is currently assessing the effect that this ASU will have on its condensed financial position, results of operations, and disclosures. Subsequent Events The Company evaluates events that have occurred after the balance sheet date of March 31, 2022, through the date which the financial statements are issued. |
Research and Development Activi
Research and Development Activity | 3 Months Ended |
Mar. 31, 2022 | |
Research and Development [Abstract] | |
RESEARCH AND DEVELOPMENT ACTIVITY | NOTE 4 According to UK tax law, the Company is allowed an R&D tax credit that reduces a company’s tax bill in the UK for expenses incurred in R&D subject to certain requirements. The Company’s UK subsidiary submits R&D tax credit requests annually for research and development expenses incurred. At March 31, 2022 and December 31, 2021, the Company recorded a research and development tax credit receivable in the amount of $3,225,000 and $3,319,000, respectively. During the three months ended March 31, 2022 and 2021, the Company received $0 of R&D tax credit reimbursements from the UK. According to AUS tax law, the Company is allowed an R&D tax credit that reduces a company’s tax bill in AUS for expenses incurred in R&D subject to certain requirements. The Company’s Australian subsidiary submits R&D tax credit requests annually for research and development expenses incurred. At March 31, 2022 and December 31, 2021, the Company recorded a research and development tax credit receivable of $1,924,000 and $1,594,000, respectively, for R&D expenses incurred in Australia. During the three months ended March 31, 2022 and 2021, the Company received $0 R&D tax credit reimbursements from Australia. Xencor, Inc. License Agreement On October 3, 2017, the Company entered into a license agreement (“Xencor License Agreement”) with Xencor, Inc. (“Xencor”), which discovered and developed a proprietary biological molecule that inhibits soluble tumor necrosis factor. During June 2021, the Company entered into the First Amendment to License Agreement. Pursuant to the Xencor License Agreement, Xencor granted the Company an exclusive worldwide, royalty-bearing license in licensed patent rights, licensed know-how and licensed materials (as defined in the license agreement) to make, develop, use, sell and import any pharmaceutical product that comprises, contains, or incorporates Xencor’s proprietary protein known as “XPro” that inhibits soluble tumor necrosis factor (or all modifications, formulations and variants of the licensed protein that specifically bind soluble tumor necrosis factor) alone or in combination with one or more active ingredients, in any dosage or formulation (“Licensed Products”). The Company believes the protein has numerous medical applications. Such additional alternative applications of the technology are available under the Xencor License Agreement. As part of the purchase price for entering into the Xencor License Agreement, the Company issued Xencor 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. On June 10, 2021, the Company and Xencor entered into an Option Cancellation Agreement whereby Xencor terminated its warrant to purchase 10% of the fully diluted shares of the Company in exchange for a cash payment of $15,000,000 and 192,533 shares of the Company’s common stock. The Company filed a registration statement covering the resale of these shares during September 2021 and agreed to keep the registration statement continuously effective until all such shares cease to be outstanding or otherwise cease to be registrable securities as defined in the Option Cancellation Agreement. The Company 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. In addition, the Company agreed to pay Xencor a percentage of any sublicensing revenue that it receives. INKmune License Agreement On October 29, 2015, the Company entered into an exclusive license agreement (the “INKmune License Agreement”) with Immune Ventures, LLC (“Immune Ventures”). Pursuant to the INKmune License Agreement, the Company was granted exclusive worldwide rights to the patents, including rights to incorporate any improvements or additions to the patents that may be developed in the future. In consideration for the patent rights, the Company agreed to the following milestone payments: (in thousands) Each Phase I initiation $ 25 Each Phase II initiation $ 250 Each Phase III initiation $ 350 Each NDA/EMA filing $ 1,000 Each NDA/EMA awarded $ 9,000 In addition, the Company agreed to pay the licensor a royalty of 1% of net sales during the life of each patent granted to the Company. The License is owned by Immune Ventures. RJ Tesi, the Company’s President and a member of our Board of Directors, David Moss, its Chief Financial Officer and Treasurer and Mark Lowdell, its Chief Scientific Officer, are the owners of Immune Ventures. No sales have occurred under this license. The term of the agreement began on October 29, 2015 and ends on a country-by-country basis on the date of the expiration of the last to expire patent rights where patent rights exists, unless terminated earlier in accordance with the agreement. Upon the termination of the agreement, we shall have a fully paid up, perpetual, royalty-free license without further obligation to Immune Ventures. The agreement can be terminated by Immune Ventures if, after 60 days from the Company’s receipt of notice that the Company has not made a payment under the agreement, and the Company still does not make this payment. On July 20, 2018, the parties amended the agreement under which the Company was required achieve milestones pursuant to the agreement. On October 30, 2020, the parties executed an additional amendment to the agreement under which the Company is required to achieve the following milestones: Initiation of Phase II clinical trials or equivalent by October 29, 2023 Initiation of Phase III clinical trials or equivalent by October 29, 2025 Filing of NDA or equivalent by October 29, 2026 or equivalent If the Company doesn’t achieve the above milestones, it is required to negotiate in good faith with Immune Ventures to determine how it can either remedy the failure or achieve an alternate development. If the Company fails to make any required efforts, or if the efforts do not remedy the situation within 60 days of written notice by Immune Ventures, then Immune Ventures may provide notice to terminate the license or convert it to a non-exclusive license. University of Pittsburg License Agreement On October 3, 2017, the Company entered into an Assignment and Assumption Agreement with Immune Ventures related to intellectual property licensed from the University of Pittsburgh. Pursuant to the Assignment and Assumption Agreement (“Assignment Agreement”), Immune Ventures assigned all of its rights, obligations and liabilities under an Exclusive License Agreement between the University of Pittsburgh – Of the Commonwealth System of Higher Education (“Licensor”) and Immune Ventures to INmune Bio (“Licensee”), (the “PITT Agreement”). Consideration under the PITT Agreement includes: (i) annual maintenance fees, (ii) royalty payments based on the sale of products making use of the licensed technology, and (iii) milestone payments. Annual maintenance fees under the PITT Agreement include the following: (in thousands) June 26 of each year 2021-2022 $ 5 June 26 of each year 2023-2024 $ 10 June 26 of each year 2025 until first commercial sale $ 25 Upon first commercial sale of a product making use of the licensed technology under the PITT Agreement, the Licensee is required to pay royalties equal to 2.5% of Net Sales each calendar quarter. Moreover, under the PITT Agreement the Licensee is required to make milestone payments as follows: (in thousands) Each Phase I initiation $ 50 Each Phase III initiation $ 500 First commercial sale of product making use of licensed technology $ 1,250 The Company had no amounts owed pursuant to the PITT Agreement as of March 31, 2022. The PITT Agreement expires upon the earlier of: (i) expiration of the last claim of the Patent Rights (as defined in the PITT Agreement) forming the subject matter of the PITT Agreement; or (ii) the date that is 20 years from the effective date of the agreement (June 26, 2037). The Licensee may terminate the PITT Agreement upon 3 months prior written notice provided all payments under the license are current. The Licensor may terminate the PITT Agreement upon written notice if: (i) Licensee defaults as to performance of material obligations which have not been cured within 60 days after receiving written notice; or (ii) Licensee ceases to carry out its business, becomes bankrupt or insolvent, applies for or consents to the appointment of a trustee, receiver or liquidator of its assets or seeks relief under any law for the aid of debtors. |
Lease
Lease | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
LEASE | NOTE 5 In May 2019, the Company signed a sublease agreement with a related party for office space in La Jolla, California, which served as the former headquarters of the Company. The lease has a 61-month term, which corresponds to the lease term of the lessor. The lessor is CTI Clinical Trial & Consulting Services (“CTI”). CTI is majority-owned by a member of the Company’s Board of Directors. During 2021, the Company moved its corporate headquarters to Boca Raton, Florida. The Company intends to sublease its office space in La Jolla. In September 2021, the Company signed a lease with a third party for office space in Boca Raton, Florida. The lease agreement has a 64-month term and commenced during the fourth quarter of 2021. Below is a summary of the Company’s right-of-use assets and liabilities: (in thousands, except years and rate) March 31, December 31, Right-of-use asset (La Jolla lease) $ 108 $ 118 Right-of-use asset (Boca Raton lease) 573 608 Total $ 681 $ 726 Operating lease, current liability (La Jolla lease) $ 66 $ 52 Operating lease, current liability (Boca Raton lease) 16 20 Total 82 72 Long-term operating lease liability (La Jolla lease) 73 84 Long-term operating lease liability (Boca Raton lease) 611 620 684 704 Total lease liability $ 766 $ 776 Weighted-average remaining lease term 4.5 years 4.6 years Weighted-average discount rate 11.70 % 11.70 % |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2022 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | NOTE 6 UCL At March 31, 2022 and December 31, 2021, the Company owed UCL Consultants Limited (“UCL”) $9,000 and $10,000, respectively, in connection with medical research performed on behalf of the Company. During the three months ended March 31, 2022 and 2021, the Company paid UCL $32,000 and $88,000, respectively, for medical research performed on behalf of the Company. At March 31, 2022 and December 31, 2021, the Company recorded $14,000 of prepaid expenses – related party for payments made to UCL in advance of services to be provided. UCL is a wholly owned subsidiary of the University of London. The Company’s Chief Scientific and Manufacturing Officer is a professor at the University of London. AmplifyBio At March 31, 2022 and December 31, 2021, the Company owed AmplifyBio $0 and $70,000, respectively in connection with medical research performed on behalf of the Company. The CEO of AmplifyBio is on the Board of Directors of the Company. During the three months ended March 31, 2022 and 2021, the Company paid AmplifyBio $80,000 and $0, respectively, for pre-clinical research performed on behalf of the Company. |
Debt
Debt | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
DEBT | NOTE 7 On June 10, 2021, the Company entered into a Loan and Security Agreement (the “Term Loan”) with Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P., together (the “Lenders”). The Term Loan provides for a $15.0 million term loan, of which the Company borrowed the entire amount on June 10, 2021, and is secured by the Company’s assets. The Term Loan also provides for the Company to request an additional $5.0 million term loan from the Lenders, which may be granted or denied at the sole discretion of the Lenders. The term loan and debt discount are as follows as of March 31, 2022: (in thousands) Term Loan $ 15,000 Less: debt discount and financing costs, net (486 ) Less: current portion - Long-term debt $ 14,514 For the three months ended March 31, 2022, the Company recognized interest expense of $435,000 related to the Term Loan. The Company is required to make interest only payments monthly until July 1, 2023 at which time the Company shall make interest and principal payments monthly through the maturity date of January 1, 2025. All outstanding principal and accrued and unpaid interest will be due and payable on the maturity date. The Term Loan provides for an annual interest rate equal to the greater of (i) the prime rate then in effect as reported in The Wall Street Journal plus 4.50% and (ii) 7.75%. At March 31, 2022, the interest rate was 8.0%. The Term Loan includes a final payment fee equal to 6.5% of the original principal amount borrowed payable on the earlier of the repayment of the loan in full and the maturity date. The Company has the option to prepay the outstanding balance of the term loans in full, subject to a prepayment premium of (i) 3% of the original principal amount borrowed for any prepayment on or prior to the first anniversary of the loan, (ii) 2% of the original principal amount borrowed for any prepayment after the first anniversary and on or before the second anniversary of the loan or (iii) 1% of the original principal amount borrowed for any prepayment after the second anniversary of the loan but before the maturity date. The expected repayment of the $15.0 million Term loan principal is as follows as of March 31, 2022: (in thousands, except years) 2022 $ - 2023 5,833 2024 9,167 Total debt 15,000 Upon the occurrence of certain events, including but not limited to the Company’s failure to satisfy its payment obligations under the Term Loan, the breach of certain of its other covenants under the Term Loan, or the occurrence of a material adverse change, the Lenders will have the right, among other remedies, to declare all principal and interest immediately due and payable, and will have the right to receive the final payment fee and, if the payment of principal and interest is due prior to maturity, the applicable prepayment fee. The Company was in compliance with its debt covenants at March 31, 2022. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
STOCKHOLDERS’ EQUITY | NOTE 8 Common Stock – Issuance to Directors and Officers During the three months ended March 31, 2022, directors and officers of the Company purchased 82,900 shares of the Company’s common stock at a per share of $8.43 (which was the closing price of the Company’s common stock on March 22, 2022) Common Stock – At the Market Offering During the three months ended March 31, 2021, the Company sold 1,439,480 shares of its common stock for aggregate gross proceeds of approximately $29.0 million (net proceeds of approximately $28.4 million) under the 2020 ATM program. The Company paid BTIG commissions and fees of $582,000 in connection with the sale of these shares. Stock options During the three months ended March 31, 2022, the Company granted certain employees and directors options to purchase 789,000 shares of its common stock pursuant to the 2021 Incentive Stock Plans. The stock options have a fair value of approximately $5.3 million that was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 1.60% - 2.36% based on the applicable US Treasury bill rate (2) expected life of 6.0 – 10.0 years, (3) expected volatility of approximately 105% - 108% based on the trading history of similar companies, and (4) zero expected dividends. The following table summarizes stock option activity during the three months ended March 31, 2022: (in thousands, except share and per share amounts) Number of Shares Weighted- average Exercise Price Weighted-average Remaining Contractual Term (years) Aggregate Intrinsic Value Outstanding at January 1, 2022 4,097,000 $ 8.67 7.21 $ 14,414 Options granted 789,000 $ 8.03 - - Options exercised - $ - - - Options cancelled (26,667 ) $ 10.38 - - Outstanding at March 31, 2022 4,859,333 $ 8.65 7.70 $ 9,026 Exercisable at March 31, 2022 2,942,016 $ 6.62 6.72 $ 6,793 During the three months ended March 31, 2022 and 2021, the Company recognized stock-based compensation expense of approximately $1.5 million and $0.9 million, respectively, related to the vesting of stock options. As of March 31, 2022, there was approximately $17.1 million of total unrecognized compensation cost related to non-vested stock options which is expected to be recognized over a weighted-average period of 2.64 years. Warrants The Company issued warrants to the Company’s lenders upon obtaining its loan in June 2021. The warrants have a 10-year term and an exercise price of $14.05. At March 31, 2022, 45,386 of these warrants are outstanding and the intrinsic value of these warrants is $0. The Company issued warrants to its placement agents in connection with its February 2019 initial public offering. The warrants are exercisable until December 19, 2023 and have an exercise price of $9.60. At March 31, 2021, 28,688 of these warrants are outstanding and the intrinsic value is $0. During 2017, the Company issued warrants to purchase shares of the Company’s common stock to a third party in conjunction with common stock sold for cash. The warrants had a $1.50 exercise price. During the three months ended March 31, 2022, the 19,792 of these warrants were exercised for cash proceeds of approximately $30,000. At March 31, 2022, none of these warrants are outstanding. Stock-based Compensation by Class of Expense The following summarizes the components of stock-based compensation expense in the consolidated statements of operations for the three months ended March 31, 2022 and 2021 respectively: (in thousands) Three Three Research and development $ 573 $ 186 General and administrative 963 713 Total $ 1,536 $ 899 Shareholder Rights Agreement On December 30, 2020, the Board of Directors (the “Board”) of the Company approved and adopted a Rights Agreement, dated as of December 30, 2020, by and between the Company and VStock Transfer, LLC, as rights agent, pursuant to which the Board declared a dividend of one preferred share purchase right (each, a “Right”) for each outstanding share of the Company’s common stock held by stockholders as of the close of business on January 11, 2021. When exercisable, each right initially would represent the right to purchase from the Company one one-thousandth of a share of a newly designated series of preferred stock, Series A Junior Participating Preferred Stock, par value $0.001 per share, of the Company, at an exercise price of $300.00 per one one-thousandth of a Series A Junior Participating Preferred Share, subject to adjustment. Subject to various exceptions, the Rights become exercisable in the event any person (excluding certain exempted or grandfathered persons) becomes the beneficial owner of twenty percent or more of the Company’s common stock without the approval of the Board. The Rights Agreement was scheduled to expire on December 30, 2021 but was extended until December 30, 2022 by the Board. |
Collaborative Agreements
Collaborative Agreements | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
COLLABORATIVE AGREEMENTS | NOTE 9 During 2020, the Company was awarded a $0.5 million grant from the Amyotrophic Lateral Sclerosis (“ALS”) Association to fund a study of the efficacy of XPro1595 to reverse ALS in vitro and to fund a study of the efficacy of XPro1595 to protect against ALS model phenotypes in vivo. During the three months ended March 31, 2022 and 2021, the Company received $0.0 million and $0.1 million, respectively, of cash proceeds pursuant to this grant which the Company recorded as deferred liabilities. The Company offsets costs incurred related to this research against the grants. As of March 31, 2022 and December 31, 2021, the Company recorded approximately $0.2 million and $0.3 million, respectively, as deferred liabilities in the consolidated balance sheet related to the ALS grant. During September 2020, the Company was awarded a grant of up to $2.9 million from the National Institutes of Health (“NIH”). The grant will support a Phase 2 study of XPro1595 in patients with treatment resistant depression. As of March 31, 2022, the Company has not received any proceeds pursuant to this grant. |
Commitments
Commitments | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS | NOTE 10 Lease In May 2019, the Company signed a sublease agreement with a related party for office space in La Jolla, California. The lease has a 61-month term, which corresponds to the lease term of the lessor. The lessor is CTI. During September 2021, the Company signed a lease agreement with a third party for office space in Boca Raton, Florida. The lease agreement has a 64-month term and commenced during the fourth quarter of 2021. Future minimum payments pursuant to the leases are as follows: (in thousands, except years) 2022 $ 135 2023 221 2024 219 2025 192 2026 198 Thereafter 51 Total lease payments 1,016 Less: imputed interest (250 ) Present value of future lease payments 766 Less: operating lease, current liabilities (82 ) Long-term operating lease liabilities $ 684 During the three months ended March 31, 2022 and 2021, the Company recognized $54,000 and $13,000, respectively, in operating lease expense, which is included in general and administrative expenses in the Company’s consolidated statement of operations. Litigation The Company is subject to claims and suits that arise from time to time in the ordinary course of our business. Although management currently believes that resolving claims against the Company, individually or in aggregate, will not have a material adverse impact in the Company’s consolidated financial statements, these matters are subject to inherent uncertainties and management’s view of these matters may change in the future. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying financial statements are presented in U.S. dollars and have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”), and pursuant to the accounting and disclosure rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The consolidated financial statements include the accounts of INmune Bio, Inc. and its subsidiaries. Intercompany transactions and balances have been eliminated. In the opinion of management, the interim financial information includes all normal recurring adjustments necessary for a fair statement of the results for the interim periods. |
Risks and Uncertainties | Risks and Uncertainties The Company is subject to risks and uncertainties as a result of the COVID-19 pandemic. The extent of the impact of the COVID-19 pandemic on the Company’s business is highly uncertain and difficult to predict. Also, economies worldwide have also been negatively impacted by the COVID-19 pandemic, however policymakers around the globe have responded with fiscal policy actions to support the healthcare industry and economy as a whole. The magnitude and overall effectiveness of these actions remain uncertain. In addition, the Company’s clinical trials have been affected by and may continue to be affected by the COVID-19 pandemic. Clinical site initiation and patient enrollment have and may continue to be delayed due to prioritization of hospital resources toward the COVID-19 pandemic. Some patients have not and others may not be able to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services. Similarly, the ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19, may adversely impact the Company’s clinical trial operations. The severity of the impact of the COVID-19 pandemic on the Company’s business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic and the extent and severity of the impact on the Company’s service providers, suppliers, contract research organizations (“CROs”) and the Company’s clinical trials, all of which are uncertain and cannot be predicted. As of the date of issuance of Company’s financial statements, the extent to which the COVID-19 pandemic may materially impact the Company’s financial condition, liquidity or results of operations is uncertain. |
Use of Estimates | Use of Estimates Preparing financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses. Actual results and outcomes may differ from management’s estimates and assumptions. |
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. |
Research and Development Tax Incentive Receivable | Research and Development Tax Incentive Receivable The Company, through its wholly-owned subsidiary in Australia (“AUS”), participates in the Australian research and development tax incentive program, such that a percentage of our qualifying research and development expenditures are reimbursed by the Australian government, and such incentives are reflected as a reduction of research and development expense. The Australian research and development tax incentive is recognized when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the amount of the consideration can be reliably measured. At each period end, management estimates the reimbursement available to the Company based on available information at the time. The Company, through its wholly-owned subsidiary in the United Kingdom (“UK”), participates in the research and development program provided by the United Kingdom tax relief program, such that a percentage of our qualifying research and development expenditures are reimbursed by the United Kingdom government, and such incentives are reflected as a reduction of research and development expense. The United Kingdom research and development tax incentive is recognized when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the amount of the consideration can be reliably measured. At each period end, management estimates the reimbursement available to the Company based on available information at the time. |
Intangible Assets | Intangible Assets The Company capitalizes costs incurred in connection with in-process research and development purchased from others if the asset has alternative uses and such uses are not restricted under applicable license agreements; patent applications (principally legal fees), patent purchases, and trademarks related to its cell line as intangible assets. Acquired in-process research and development costs that do not have alternative uses are expensed as incurred. When the assets are determined to have a finite life (upon completion of the development of the in-process research and development for its DN-TNF platform), the useful life will be determined and the in-process research and development intangible assets will be amortized. During the fourth quarter and if business factors indicate more frequently, the Company performs an assessment of the qualitative factors affecting the fair value of our in-process research and development. If the qualitative assessment suggests that impairment is more likely than not, a quantitative analysis is performed. The quantitative analysis involves a comparison of the fair value of the in-process research and development with the carrying amount. If the carrying amount of the in-process research and development exceeds its fair value, an impairment loss is recognized in an amount equal to that excess. |
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, 2022 and 2021, the Company had potentially issuable shares as follows: March 31, 2022 2021 Stock options 4,859,333 3,655,549 Warrants 80,221 2,126,047 Total 4,939,554 5,781,596 |
Revenue Recognition | Revenue Recognition The Company recognizes revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. The Company recognizes revenue following the five-step model prescribed under ASC Topic 606: (1) identify contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenues when (or as) the Company satisfies the performance obligations. The Company records the expenses related to revenue in research and development expense, in the periods such expenses were incurred. The Company records deferred revenues when cash payments are received or due in advance of performance, including amounts which are refundable. |
Stock-Based Compensation | Stock-Based Compensation The Company utilizes the Black-Scholes option pricing model to estimate the fair value of stock option awards at the date of grant, which requires the input of highly subjective assumptions, including expected volatility and expected life. Changes in these inputs and assumptions can materially affect the measure of estimated fair value of our share-based compensation. These assumptions are subjective and generally require significant analysis and judgment to develop. When estimating fair value, some of the assumptions will be based on, or determined from, external data and other assumptions may be derived from our historical experience with stock-based payment arrangements. The appropriate weight to place on historical experience is a matter of judgment, based on relevant facts and circumstances. The Company accounts for forfeitures of stock options as they occur. |
Research and Development | Research and Development Research and development (“R&D”) costs are expensed as incurred. Research and development credits are recorded by the Company as a reduction of research and development costs. Major components of research and development costs include cash compensation, stock-based compensation, costs of preclinical studies, clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf. The Company recognizes grants as contra research and development expense in the consolidated statement of operations on a systematic basis over the periods in which the entity recognizes as expenses the related costs for which the grants are intended to compensate. |
Income Taxes | Income Taxes The Company follows the liability method of accounting for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the estimated tax consequences attributable to differences between the financial statement carrying values and their respective income tax basis (temporary differences). The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. |
Foreign Currency Translation | Foreign Currency Translation The Company’s financial statements are presented in the U.S. dollar (“$”), which is the Company’s reporting currency, while its functional currencies are the U.S. Dollar for its U.S. based operations, British Pound (“GBP”) for its United Kingdom-based operations and Australian Dollars (“AUD”) for its Australian-based operations. All assets and liabilities are translated at the exchange rate on the balance sheet date, stockholders’ equity is translated at historical rates and statement of operations items are translated at the weighted average exchange rate for the period. The resulting translation adjustments are reported under other comprehensive income. Gains and losses resulting from the translations of foreign currency transactions and balances are reflected in the statement of operations and comprehensive income (loss). |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments, as clarified in subsequent amendments. ASU 2016-13 changes the impairment model for certain financial instruments. The new model is a forward-looking expected loss model and will apply to financial assets subject to credit losses and measured at amortized cost and certain off-balance sheet credit exposures. This includes loans, held-to-maturity debt securities, loan commitments, financial guarantees and net investments in leases, as well as trade receivables. For available-for-sale debt securities with unrealized losses, credit losses will be measured in a manner similar to today, except that the losses will be recognized as allowances rather than reductions in the amortized cost of the securities. In October 2019, the FASB voted to delay the effective date of this standard. Topic 326 will be effective for the Company on January 1, 2023. Early adoption is permitted. The Company is currently assessing the effect that this ASU will have on its condensed financial position, results of operations, and disclosures. |
Subsequent Events | Subsequent Events The Company evaluates events that have occurred after the balance sheet date of March 31, 2022, through the date which the financial statements are issued. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of potentially issuable shares | March 31, 2022 2021 Stock options 4,859,333 3,655,549 Warrants 80,221 2,126,047 Total 4,939,554 5,781,596 |
Research and Development Acti_2
Research and Development Activity (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Research and Development [Abstract] | |
Schedule of milestone payments in consideration for the patent rights | Each Phase I initiation $ 25 Each Phase II initiation $ 250 Each Phase III initiation $ 350 Each NDA/EMA filing $ 1,000 Each NDA/EMA awarded $ 9,000 |
Schedule of consideration of annual maintenance fees under the PITT agreement | June 26 of each year 2021-2022 $ 5 June 26 of each year 2023-2024 $ 10 June 26 of each year 2025 until first commercial sale $ 25 |
Schedule of licensee is required to make milestone payments | Each Phase I initiation $ 50 Each Phase III initiation $ 500 First commercial sale of product making use of licensed technology $ 1,250 |
Lease (Tables)
Lease (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
Schedule of right-of-use assets and liabilities | (in thousands, except years and rate) March 31, December 31, Right-of-use asset (La Jolla lease) $ 108 $ 118 Right-of-use asset (Boca Raton lease) 573 608 Total $ 681 $ 726 Operating lease, current liability (La Jolla lease) $ 66 $ 52 Operating lease, current liability (Boca Raton lease) 16 20 Total 82 72 Long-term operating lease liability (La Jolla lease) 73 84 Long-term operating lease liability (Boca Raton lease) 611 620 684 704 Total lease liability $ 766 $ 776 Weighted-average remaining lease term 4.5 years 4.6 years Weighted-average discount rate 11.70 % 11.70 % |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of term loan and debt discount | Term Loan $ 15,000 Less: debt discount and financing costs, net (486 ) Less: current portion - Long-term debt $ 14,514 |
Schedule of repayment term loan principal | 2022 $ - 2023 5,833 2024 9,167 Total debt 15,000 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
Schedule of stock option activity | (in thousands, except share and per share amounts) Number of Shares Weighted- average Exercise Price Weighted-average Remaining Contractual Term (years) Aggregate Intrinsic Value Outstanding at January 1, 2022 4,097,000 $ 8.67 7.21 $ 14,414 Options granted 789,000 $ 8.03 - - Options exercised - $ - - - Options cancelled (26,667 ) $ 10.38 - - Outstanding at March 31, 2022 4,859,333 $ 8.65 7.70 $ 9,026 Exercisable at March 31, 2022 2,942,016 $ 6.62 6.72 $ 6,793 |
Schedule of stock-based compensation expense | (in thousands) Three Three Research and development $ 573 $ 186 General and administrative 963 713 Total $ 1,536 $ 899 |
Commitments (Tables)
Commitments (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of future minimum payments pursuant leases | 2022 $ 135 2023 221 2024 219 2025 192 2026 198 Thereafter 51 Total lease payments 1,016 Less: imputed interest (250 ) Present value of future lease payments 766 Less: operating lease, current liabilities (82 ) Long-term operating lease liabilities $ 684 |
Liquidity (Details)
Liquidity (Details) - USD ($) | 1 Months Ended | 3 Months Ended | ||
Jul. 31, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Mar. 31, 2022 | |
Liquidity (Details) [Line Items] | ||||
Accumulated deficit | $ 70,618,000 | |||
Sale of common stock shares (in Shares) | 713,192 | 82,900 | ||
Price per share (in Dollars per share) | $ 8.43 | |||
Offering program common stock value | $ 45,000,000 | $ 700,000 | ||
Term loan | $ 15,000,000 | |||
Gross proceeds from the sale of shares, percentage | 3.00% | |||
Average price per share (in Dollars per share) | $ 21.73 | |||
Net proceeds from common stock | $ 14,900,000 | |||
Public Offering [Member] | ||||
Liquidity (Details) [Line Items] | ||||
Sale of common stock shares (in Shares) | 1,818,182 | |||
Offering program common stock value | $ 36,900,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Original maturity | 3 months |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - Schedule of potentially issuable shares - shares | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Summary of Significant Accounting Policies (Details) - Schedule of potentially issuable shares [Line Items] | ||
Total | 4,939,554 | 5,781,596 |
Warrants [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of potentially issuable shares [Line Items] | ||
Total | 80,221 | 2,126,047 |
Stock Options [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of potentially issuable shares [Line Items] | ||
Total | 4,859,333 | 3,655,549 |
Research and Development Acti_3
Research and Development Activity (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Research and Development Activity (Details) [Line Items] | ||
Cash payment | $ 15,000,000 | |
Shares issued (in Shares) | 192,533 | |
Xencor, Inc. License Agreement [Member] | ||
Research and Development Activity (Details) [Line Items] | ||
Common stock equal to fully diluted shares to purchase with fair value | 10.00% | |
Intangible assets | $ 0.10 | |
Immune Ventures [Member] | ||
Research and Development Activity (Details) [Line Items] | ||
Percentage of licensor royalty patent grant | 1.00% | |
University of Pittsburg License Agreement [Member] | ||
Research and Development Activity (Details) [Line Items] | ||
Percentage of net sales to pay royalties | 2.50% | |
Immune Ventures [Member] | ||
Research and Development Activity (Details) [Line Items] | ||
Agreement expiry period, description | The PITT Agreement expires upon the earlier of: (i) expiration of the last claim of the Patent Rights (as defined in the PITT Agreement) forming the subject matter of the PITT Agreement; or (ii) the date that is 20 years from the effective date of the agreement (June 26, 2037). | |
United Kingdom [Member] | Research and Development Expense [Member] | ||
Research and Development Activity (Details) [Line Items] | ||
Research and development tax credit receivable | $ 3,225,000 | 3,319,000 |
Reimbursements of research and development tax credit | 0 | |
Australia [Member] | ||
Research and Development Activity (Details) [Line Items] | ||
Reimbursements of research and development tax credit | 0 | |
Australia [Member] | Research and Development Expense [Member] | ||
Research and Development Activity (Details) [Line Items] | ||
Research and development tax credit receivable | $ 1,924,000 | $ 1,594,000 |
Research and Development Acti_4
Research and Development Activity (Details) - Schedule of milestone payments in consideration for the patent rights $ in Thousands | 3 Months Ended |
Mar. 31, 2022USD ($) | |
Each Phase I initiation [Member] | |
Research and Development Activity (Details) - Schedule of milestone payments in consideration for the patent rights [Line Items] | |
Payment method of milestone payments | $ 25 |
Each Phase II initiation [Member] | |
Research and Development Activity (Details) - Schedule of milestone payments in consideration for the patent rights [Line Items] | |
Payment method of milestone payments | 250 |
Each Phase III initiation [Member] | |
Research and Development Activity (Details) - Schedule of milestone payments in consideration for the patent rights [Line Items] | |
Payment method of milestone payments | 350 |
Each NDA/EMA filing [Member] | |
Research and Development Activity (Details) - Schedule of milestone payments in consideration for the patent rights [Line Items] | |
Payment method of milestone payments | 1,000 |
Each NDA/EMA awarded [Member] | |
Research and Development Activity (Details) - Schedule of milestone payments in consideration for the patent rights [Line Items] | |
Payment method of milestone payments | $ 9,000 |
Research and Development Acti_5
Research and Development Activity (Details) - Schedule of consideration of annual maintenance fees under the PITT agreement $ in Thousands | Mar. 31, 2022USD ($) |
June 26 of each year 2021-2022 [Member] | |
Research and Development Activity (Details) - Schedule of consideration of annual maintenance fees under the PITT agreement [Line Items] | |
Annual maintenance fees until first commercial sale | $ 5 |
June 26 of each year 2023-2024 [Member] | |
Research and Development Activity (Details) - Schedule of consideration of annual maintenance fees under the PITT agreement [Line Items] | |
Annual maintenance fees until first commercial sale | 10 |
June 26 of each year 2025 until first commercial sale [Member] | |
Research and Development Activity (Details) - Schedule of consideration of annual maintenance fees under the PITT agreement [Line Items] | |
Annual maintenance fees until first commercial sale | $ 25 |
Research and Development Acti_6
Research and Development Activity (Details) - Schedule of licensee is required to make milestone payments $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Each Phase I initiation [Member] | |
Research and Development Activity (Details) - Schedule of licensee is required to make milestone payments [Line Items] | |
Payment method of milestone payments | $ 50 |
Each Phase III initiation [Member] | |
Research and Development Activity (Details) - Schedule of licensee is required to make milestone payments [Line Items] | |
Payment method of milestone payments | 500 |
First commercial sale of product making use of licensed technology [Member] | |
Research and Development Activity (Details) - Schedule of licensee is required to make milestone payments [Line Items] | |
Payment method of milestone payments | $ 1,250 |
Lease (Details)
Lease (Details) | Dec. 31, 2021 | May 31, 2019 |
Leases (Details) [Line Items] | ||
Lease term | 64 months | 61 months |
Lease (Details) - Schedule of r
Lease (Details) - Schedule of right-of-use assets and liabilities - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Lease (Details) - Schedule of right-of-use assets and liabilities [Line Items] | ||
Right-of-use asset | $ 681 | $ 726 |
Operating lease, current liability | 82 | 72 |
Long-term operating lease liability | 684 | 704 |
Total lease liability | $ 766 | $ 776 |
Weighted-average remaining lease term | 4 years 6 months | 4 years 7 months 6 days |
Weighted-average discount rate | 11.70% | 11.70% |
La Jolla lease [Member] | ||
Lease (Details) - Schedule of right-of-use assets and liabilities [Line Items] | ||
Right-of-use asset | $ 108 | $ 118 |
Operating lease, current liability | 66 | 52 |
Long-term operating lease liability | 73 | 84 |
Boca Raton lease [Member] | ||
Lease (Details) - Schedule of right-of-use assets and liabilities [Line Items] | ||
Right-of-use asset | 573 | 608 |
Operating lease, current liability | 16 | 20 |
Long-term operating lease liability | $ 611 | $ 620 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Related Party Transactions (Details) [Line Items] | |||
Amount owed | $ 9,000 | $ 80,000 | |
Prepaid expenses-related party | 14,000 | 14,000 | |
UCL Consultants Limited [Member] | |||
Related Party Transactions (Details) [Line Items] | |||
Amount owed | 9,000 | 10,000 | |
Payment for medical research performed expense | 32,000 | $ 88,000 | |
CTI [Member] | |||
Related Party Transactions (Details) [Line Items] | |||
Payment for medical research performed expense | 0 | $ 70,000 | |
Amount paid for sublease agreement | $ 80,000 | $ 0 |
Debt (Details)
Debt (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Jun. 10, 2021 | |
Debt (Details) [Line Items] | ||
Term loan from lenders (in Dollars) | $ 15,000,000 | |
Term loan additional from lenders (in Dollars) | $ 5,000,000 | |
Recognized interest expense (in Dollars) | $ 435,000 | |
Description of loan repayment in terms | The Company is required to make interest only payments monthly until July 1, 2023 at which time the Company shall make interest and principal payments monthly through the maturity date of January 1, 2025. | |
Interest rate | 8.00% | |
Original principal amount borrowed for prepayment percentage | 3.00% | |
Original principal amount borrowed for prepayment percentage before second loan | 2.00% | |
Original principal amount borrowed for prepayment percentage before maturity date | 1.00% | |
Term loan repayment (in Dollars) | $ 15,000,000 | |
The Wall Street Journal plus [Member] | ||
Debt (Details) [Line Items] | ||
Prime rate, percentage | 4.50% | |
Interest rate | 7.75% | |
Amount borrowed, percentage | 6.50% |
Debt (Details) - Schedule of te
Debt (Details) - Schedule of term loan and debt discount $ in Thousands | Mar. 31, 2022USD ($) |
Schedule of term loan and debt discount [Abstract] | |
Term Loan | $ 15,000 |
Less: debt discount and financing costs, net | (486) |
Less: current portion | |
Long-term debt | $ 14,514 |
Debt (Details) - Schedule of re
Debt (Details) - Schedule of repayment term loan principal $ in Thousands | Mar. 31, 2022USD ($) |
Schedule of repayment term loan principal [Abstract] | |
2022 | |
2023 | 5,833 |
2024 | 9,167 |
Total debt | $ 15,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 30, 2020 | Dec. 19, 2023 | |
Stockholders' Equity (Details) [Line Items] | |||||
Number of common stock sold (in Shares) | 713,192 | 82,900 | |||
Per share price (in Dollars per share) | $ 8.43 | ||||
Common Stock, Discount on Shares | $ 699,000 | ||||
Commissions paid | 582,000 | ||||
Aggregated fair value of stock options | 5,300,000 | ||||
Stock-based compensation expense | $ 1,500,000 | $ 900,000 | |||
Weighted-average period | 2 years 7 months 20 days | ||||
Unrecognized compensation cost | $ 17,100,000 | ||||
Exercise price (in Dollars per share) | $ 8.43 | ||||
Intrinsic value of warrants | $ 0 | ||||
Shareholder rights agreement, description | the Company one one-thousandth of a share of a newly designated series of preferred stock, Series A Junior Participating Preferred Stock, par value $0.001 per share, of the Company, at an exercise price of $300.00 per one one-thousandth of a Series A Junior Participating Preferred Share, subject to adjustment. Subject to various exceptions, the Rights become exercisable in the event any person (excluding certain exempted or grandfathered persons) becomes the beneficial owner of twenty percent or more of the Company’s common stock without the approval of the Board. | ||||
Common Stock [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Number of common stock sold (in Shares) | 82,900 | ||||
Warrant [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
warrants are outstanding | $ 45,386 | ||||
Cash proceeds | $ 30,000 | ||||
Minimum [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Discount rate | 1.60% | ||||
Expected life | 6 years | ||||
Expected volatility rate | 105.00% | ||||
Maximum [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Discount rate | 2.36% | ||||
Expected life | 10 years | ||||
Expected volatility rate | 108.00% | ||||
Warrant [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Exercise price (in Dollars per share) | $ 14.05 | $ 9.6 | |||
warrants are outstanding | $ 0 | $ 0 | |||
Warrants are outstanding (in Shares) | 28,688 | 28,688 | |||
Warrants exercised (in Shares) | 19,792 | ||||
Warrant [Member] | Common Stock [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Exercise price (in Dollars per share) | $ 1.5 | ||||
Employees and Directors [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Purchase of shares (in Shares) | 789,000 | ||||
Lincoln Park [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Description of sale of stock | During the three months ended March 31, 2021, the Company sold 1,439,480 shares of its common stock for aggregate gross proceeds of approximately $29.0 million (net proceeds of approximately $28.4 million) under the 2020 ATM program. |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - Schedule of stock option activity $ / shares in Units, $ in Thousands | 3 Months Ended |
Mar. 31, 2022USD ($)$ / sharesshares | |
Schedule of stock option activity [Abstract] | |
Number of shares, Outstanding, Beginning balance (in Shares) | shares | 4,097,000 |
Weighted- average Exercise Price, Outstanding, Beginning balance | $ 8.67 |
Weighted-average Remaining Contractual Term (years), Outstanding, Beginning balance | 7 years 2 months 15 days |
Aggregate Intrinsic Value, Outstanding, Beginning balance (in Dollars) | $ | $ 14,414 |
Number of shares, Options granted (in Shares) | shares | 789,000 |
Weighted- average Exercise Price, Options granted | $ 8.03 |
Weighted- average Remaining Contractual Term (years), Options granted | |
Aggregate Intrinsic Value, Options granted | |
Number of shares, Options exercised (in Shares) | shares | |
Weighted- average Exercise Price, Options exercised | |
Weighted- average Remaining Contractual Term (years), Options exercised | |
Aggregate Intrinsic Value, Options exercised (in Dollars) | $ | |
Number of shares, Options cancelled (in Shares) | shares | (26,667) |
Weighted- average Exercise Price, Options cancelled | $ 10.38 |
Weighted- average Remaining Contractual Term (years), Options cancelled | |
Aggregate Intrinsic Value, Options cancelled (in Dollars) | $ | |
Number of shares, Outstanding, Ending balance (in Shares) | shares | 4,859,333 |
Weighted- average Exercise Price, Outstanding, Ending balance | $ 8.65 |
Weighted-average Remaining Contractual Term (years), Outstanding, Ending balance | 7 years 8 months 12 days |
Aggregate Intrinsic Value, Outstanding, Ending balance (in Dollars) | $ | $ 9,026 |
Number of shares, Exercisable, Ending balance (in Shares) | shares | 2,942,016 |
Weighted- average Exercise Price, Exercisable, Ending balance | $ 6.62 |
Weighted-average Remaining Contractual Term (years), Exercisable, Ending balance | 6 years 8 months 19 days |
Aggregate Intrinsic Value, Exercisable, Ending balance (in Dollars) | $ | $ 6,793 |
Stockholders' Equity (Details_2
Stockholders' Equity (Details) - Schedule of stock-based compensation expense - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Research and development [Member] | ||
Stockholders' Equity (Details) - Schedule of stock-based compensation expense [Line Items] | ||
Total | $ 573 | $ 186 |
General and administrative [Member] | ||
Stockholders' Equity (Details) - Schedule of stock-based compensation expense [Line Items] | ||
Total | 963 | 713 |
Total [Member] | ||
Stockholders' Equity (Details) - Schedule of stock-based compensation expense [Line Items] | ||
Total | $ 1,536 | $ 899 |
Collaborative Agreements (Detai
Collaborative Agreements (Details) - USD ($) $ in Millions | 1 Months Ended | |||
Dec. 31, 2020 | Sep. 30, 2020 | Mar. 31, 2022 | Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Grand award,description | During 2020, the Company was awarded a $0.5 million grant from the Amyotrophic Lateral Sclerosis (“ALS”) Association to fund a study of the efficacy of XPro1595 to reverse ALS in vitro and to fund a study of the efficacy of XPro1595 to protect against ALS model phenotypes in vivo. | the Company was awarded a grant of up to $2.9 million from the National Institutes of Health (“NIH”). The grant will support a Phase 2 study of XPro1595 in patients with treatment resistant depression. As of March 31, 2022, the Company has not received any proceeds pursuant to this grant. | ||
Grants received | $ 0 | $ 0.1 | ||
Grants recorded approximately | $ 0.2 | $ 0.3 |
Commitments (Details)
Commitments (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease expense | $ 54,000 | $ 13,000 |
Commitments (Details) - Schedul
Commitments (Details) - Schedule of future minimum payments pursuant leases - Commitments [Member] $ in Thousands | Mar. 31, 2022USD ($) |
Commitments (Details) - Schedule of future minimum payments pursuant leases [Line Items] | |
2022 | $ 135 |
2023 | 221 |
2024 | 219 |
2025 | 192 |
2026 | 198 |
Thereafter | 51 |
Total lease payments | 1,016 |
Less: imputed interest | (250) |
Present value of future lease payments | 766 |
Less: operating lease, current liabilities | (82) |
Long-term operating lease liabilities | $ 684 |