−Removed: Financial Statements and Supplementary Data
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: AUDITED FINANCIAL
−Removed: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
−Removed: CONSOLIDATED BALANCE SHEETS AS OF DECEMBER 31, 2020 AND 2019
−Removed: CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE YEARS ENDED DECEMBER 31, 2020 AND 2019
−Removed: CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’
−Removed: EQUITY FOR THE YEARS ENDED DECEMBER 31, 2020 AND 2019
−Removed: CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED DECEMBER 31, 2020 AND 2019
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
−Removed: the Stockholders and the Board of Directors of
−Removed: Jolla, California
−Removed: on the Financial Statements
−Removed: have audited the accompanying consolidated balance sheets of INmune Bio, Inc.
−Removed: (the “Company”) as of December 31,
−Removed: 2020 and 2019, the related consolidated statements of operations and comprehensive loss, stockholders’
−Removed: equity and cash flows
−Removed: for the years ended December 31, 2020 and 2019, and the related notes (collectively referred to as the “financial statements”).
−Removed: In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of
−Removed: December 31, 2020 and 2019, and the results of its operations and its cash flows for the years ended December 31, 2020 and 2019,
−Removed: in conformity with accounting principles generally accepted in the United States of America.
−Removed: financial statements are the responsibility of the Company’s management.
−Removed: Our responsibility is to express an opinion on
−Removed: the Company’s financial statements based on our audits.
−Removed: We are a public accounting firm registered with the Public Company
−Removed: Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company
−Removed: in accordance with the U.S.
−Removed: federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission
−Removed: and the PCAOB.
−Removed: conducted our audits in accordance with the standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audits
−Removed: to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error
−Removed: The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial
−Removed: As part of our audits we are required to obtain an understanding of internal control over financial reporting but not
−Removed: for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.
+Added: Financial Statements and Supplementary
+Added: INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: AUDITED FINANCIAL STATEMENTS:
+Added: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB ID Number 688 )
+Added: CONSOLIDATED BALANCE SHEETS AS OF DECEMBER 31, 2021 AND 2020 F-2
+Added: CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE YEARS ENDED DECEMBER 31, 2021 AND 2020 F-3
+Added: CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY FOR THE YEARS ENDED DECEMBER 31, 2021 AND 2020 F-4
+Added: CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED DECEMBER 31, 2021 AND 2020 F-5
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS F-6
+Added: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
+Added: To the Stockholders and the Board of Directors
+Added: INmune Bio, Inc.
+Added: Boca Raton, Florida
+Added: Opinion on the Financial Statements
+Added: We have audited the accompanying consolidated
+Added: balance sheets of INmune Bio, Inc.
+Added: (the “Company”) as of December 31, 2021 and 2020, the related consolidated statements
+Added: of operations and comprehensive loss, changes in stockholders’ equity and cash flows for each of the two years in the period ended
+Added: December 31, 2021, and the related notes (collectively referred to as the “financial statements”).
+Added: In our opinion, the financial
+Added: statements present fairly, in all material respects, the financial position of the Company as of December 31, 2021 and 2020, and the results
+Added: of its operations and its cash flows for each of the two years in the period ended December 31, 2021, in conformity with accounting principles
+Added: generally accepted in the United States of America.
+Added: Basis for Opinion
+Added: These financial statements are the responsibility
+Added: of the Company's management.
+Added: Our responsibility is to express an opinion on the Company's financial statements based on our audits.
+Added: are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are
+Added: required to be independent with respect to the Company in accordance with the U.S.
+Added: federal securities laws and the applicable rules and
+Added: regulations of the Securities and Exchange Commission and the PCAOB.
+Added: We conducted our audits in accordance with the
+Added: standards of the PCAOB.
+Added: Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial
+Added: statements are free of material misstatement, whether due to error or fraud.
+Added: The Company is not required to have, nor were we engaged
+Added: to perform, an audit of its internal control over financial reporting.
+Added: As part of our audits, we are required to obtain an understanding
+Added: of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal
+Added: control over financial reporting.
Accordingly, we express no such opinion.
−Removed: audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to
−Removed: error or fraud, and performing procedures that respond to those risks.
−Removed: Such procedures included examining, on a test basis, evidence
−Removed: regarding the amounts and disclosures in the financial statements.
−Removed: Our audits also included evaluating the accounting principles
−Removed: used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.
+Added: Our audits included performing procedures to assess
+Added: the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
+Added: to those risks.
+Added: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
+Added: Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
+Added: the overall presentation of the financial statements.
We believe that our audits provide a reasonable basis for our opinion.
−Removed: have served as the Company’s auditor since 2017.
−Removed: BALANCE SHEETS
+Added: /s/ Marcum llp
+Added: We have served as the Company’s auditor since 2017.
+Added: Houston, Texas
+Added: March 3, 2022
+Added: INMUNE BIO, INC.
+Added: CONSOLIDATED BALANCE SHEETS
+Added: (In thousands, except share and per share amounts)
CURRENT ASSETS
2 unchanged sentences
Prepaid expenses
−Removed: Prepaid expenses –
−Removed: related party
+Added: Prepaid expenses – related party
TOTAL CURRENT ASSETS
−Removed: Operating lease –
−Removed: right of use asset –
−Removed: related party
+Added: Operating lease – right of use assets
Acquired in-process research and development intangible assets
−Removed: LIABILITIES AND STOCKHOLDERS’
+Added: LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable and accrued liabilities
−Removed: Accounts payable and accrued liabilities –
−Removed: related parties
+Added: Accounts payable and accrued liabilities – related parties
Deferred liabilities
−Removed: Operating lease, current liability –
−Removed: related party
+Added: Operating lease, current liabilities
TOTAL CURRENT LIABILITIES
−Removed: Long-term operating lease liability –
−Removed: related party
+Added: Long-term debt, less debt discount
+Added: Long-term operating lease liabilities
+Added: Accrued liability – long-term
TOTAL LIABILITIES
COMMITMENTS AND CONTINGENCIES
−Removed: STOCKHOLDERS’
+Added: STOCKHOLDERS’ EQUITY
Preferred stock, $ 0.001 par value, 10,000,000 shares authorized, 0 shares issued and outstanding
1 unchanged sentence
Additional paid-in capital
−Removed: Common stock issuable
−Removed: Accumulated other comprehensive income (loss)
+Added: Accumulated other comprehensive income
Accumulated deficit
−Removed: (33,375,340 )
−Removed: (21,276,181 )
−Removed: TOTAL STOCKHOLDERS’
−Removed: TOTAL LIABILITIES AND STOCKHOLDERS’
−Removed: accompanying notes to these consolidated financial statements.
−Removed: STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
−Removed: THE YEARS ENDED DECEMBER 31, 2020 AND 2019
+Added: TOTAL STOCKHOLDERS’ EQUITY
+Added: TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
+Added: See accompanying notes to these consolidated financial
+Added: INMUNE BIO, INC.
+Added: CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021 AND 2020
+Added: thousands, except share and per share amounts)
OPERATING EXPENSES
1 unchanged sentence
Research and development
−Removed: Gain on waiver of common stock issuable
Total operating expenses
LOSS FROM OPERATIONS
−Removed: (12,227,676 )
−Removed: Total other income
−Removed: $ (12,099,159 )
−Removed: $ (7,678,313 )
−Removed: Net loss per common share –
−Removed: basic and diluted
−Removed: Weighted average number of common shares outstanding –
−Removed: basic and diluted
+Added: OTHER (EXPENSE) INCOME
+Added: Other (expense) income
+Added: Total other (expense) income
+Added: Net loss per common share – basic and diluted
+Added: Weighted average number of common shares outstanding – basic and diluted
COMPREHENSIVE LOSS
−Removed: $ (12,099,159 )
−Removed: $ (7,678,313 )
−Removed: Other comprehensive (income) loss –
−Removed: foreign currency translation
+Added: Other comprehensive (loss) income – foreign currency translation
Total comprehensive loss
−Removed: $ (12,079,936 )
−Removed: $ (7,693,357 )
−Removed: accompanying notes to these consolidated financial statements.
−Removed: STATEMENT OF CHANGES IN STOCKHOLDERS’
−Removed: THE YEARS ENDED DECEMBER 31, 2020 AND 2019
+Added: See accompanying notes to these consolidated financial
+Added: INMUNE BIO, INC.
+Added: CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021 AND 2020
+Added: (In thousands, except share amounts)
Comprehensive
−Removed: Stockholders’
+Added: Stockholders’
Income (loss)
Balance as of January 1, 2020
−Removed: $ (13,597,868 )
−Removed: Issuance of common stock and warrants for cash, net
−Removed: Issuance of common stock issuable
−Removed: Waiver of common stock issuable
−Removed: Stock-based compensation
−Removed: Loss on foreign currency translation
−Removed: Balance as of December 31, 2019
−Removed: (21,276,181 )
Issuance of common stock for cash, net
5 unchanged sentences
Gain on foreign currency translation
−Removed: (12,099,159 )
−Removed: (12,099,159 )
Balance as of December 31, 2020
−Removed: $ (33,375,340 )
−Removed: accompanying notes to these consolidated financial statements.
−Removed: STATEMENTS OF CASH FLOWS
−Removed: THE YEARS ENDED DECEMBER 31, 2020 AND 2019
+Added: Issuance of common stock for cash, net
+Added: Settlement of Xencor warrant for cash and common stock
+Added: Warrants issued to lenders as debt inducement
+Added: Exercise of warrants
+Added: Exercise of stock options
+Added: Stock-based compensation
+Added: Loss on foreign currency translation
+Added: Balance as of December 31, 2021
+Added: See accompanying notes to these consolidated financial
+Added: INMUNE BIO, INC.
+Added: CONSOLIDATED STATEMENTS OF CASH FLOWS
+Added: FOR THE YEARS ENDED DECEMBER 31, 2021 AND 2020
+Added: (In thousands)
CASH FLOWS FROM OPERATING ACTIVITIES:
−Removed: $ (12,099,159 )
−Removed: $ (7,678,313 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
−Removed: Gain on waiver of common stock issuable
+Added: Accretion of debt discount
Changes in operating assets and liabilities:
1 unchanged sentence
Other tax receivable
−Removed: Joint development cost receivable
Prepaid expenses
−Removed: Prepaid expenses –
−Removed: related party
+Added: Prepaid expenses – related party
Accounts payable and accrued liabilities
−Removed: Accounts payable and accrued liabilities –
−Removed: related parties
+Added: Accounts payable and accrued liabilities – related parties
Deferred liabilities
−Removed: Operating lease liability –
−Removed: related party
+Added: Accrued liability – long-term
+Added: Operating lease liabilities
Net cash used in operating activities
+Added: CASH FROM INVESTING ACTIVITIES
+Added: Cash paid to Xencor to settle warrant for acquired research and development intangible assets
+Added: Net cash used in investing activities
CASH FLOWS FROM FINANCING ACTIVITIES:
+Added: Net proceeds from the issuance of debt
Net proceeds from sale of common stock
+Added: Net proceeds from the exercise of stock options
+Added: Net proceeds from the exercise of warrants
Purchase of common stock
8 unchanged sentences
NONCASH INVESTING AND FINANCING ACTIVITIES:
+Added: Common stock issued to Xencor to settle warrant issued for acquired research and development intangible assets
+Added: Warrants issued to lenders as debt inducement
Capital contribution
−Removed: Cashless exercise of warrants
Issuance of common stock issuable
−Removed: Issuance of warrants to placement agents
−Removed: accompanying notes to these consolidated financial statements.
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: ORGANIZATION AND BASIS OF PRESENTATION
−Removed: and Business Overview
−Removed: (the “Company”
−Removed: or “INmune Bio”) was organized in the State of Nevada on September 25, 2015,
−Removed: and is a clinical stage biotechnology pharmaceutical company focused on developing and commercializing its product candidates
−Removed: to treat diseases where the innate immune system is not functioning normally and contributing to the patient’s disease.
+Added: See accompanying notes to these consolidated financial
+Added: INMUNE BIO, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: NOTE 1 – ORGANIZATION AND BASIS
+Added: OF PRESENTATION
+Added: Organization and Business Overview
+Added: INmune Bio, Inc.
+Added: (the “Company” or
+Added: “INmune Bio”) was organized in the State of Nevada on September 25, 2015, and is a clinical stage biotechnology pharmaceutical
+Added: company focused on developing and commercializing its product candidates to treat diseases where the innate immune system is not functioning
+Added: normally and contributing to the patient’s disease.
INmune Bio has two product platforms.
−Removed: The DN-TNF product platform utilizes dominant-negative technology to selectively neutralize
−Removed: soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases.
−Removed: DN-TNF is currently being developed
−Removed: for COVID-19 complications (Quellor), cancer (INB03), Alzheimer’s and treatment resistant depression (XPro595), and NASH
−Removed: The Natural Killer Cell Priming Platform includes INKmune aimed at priming the patient’s NK cells to eliminate
−Removed: minimal residual disease in patients with cancer.
−Removed: INmune Bio’s product platforms utilize a precision medicine approach for
−Removed: the treatment of a wide variety of hematologic malignancies, solid tumors and chronic inflammation.
−Removed: of Presentation and Principles of Consolidation
−Removed: accompanying consolidated financial statements of the Company have been prepared in accordance with Generally Accepted Accounting
−Removed: Principles (“US GAAP”) in the United States of America and the rules of the Securities and Exchange Commission (“SEC”).
−Removed: consolidated financial statements herein have been prepared in accordance with US GAAP and include the accounts of INmune Bio,
−Removed: its wholly-owned UK subsidiary, and its wholly-owned Australia subsidiary (collectively, the “Company”).
−Removed: All significant
−Removed: intercompany accounts and transactions have been eliminated.
−Removed: of December 31, 2020, the Company had an accumulated deficit of $33,375,340 and experienced losses since its inception.
−Removed: have principally occurred as a result of non-cash stock-based compensation expense and the substantial resources required for
−Removed: research and development of the Company’s products, which included the general and administrative expenses associated with
−Removed: its organization and product development as well as the lack of sources of revenues until such time as the Company’s products
+Added: The DN-TNF product platform utilizes
+Added: dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of
+Added: many diseases.
+Added: DN-TNF is currently being developed for Alzheimer’s and treatment resistant depression (XPro) and cancer (INB03).
+Added: The Natural Killer Cell Priming Platform includes INKmune aimed at priming the patient’s NK cells to eliminate minimal residual
+Added: disease in patients with cancer.
+Added: INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide
+Added: variety of hematologic malignancies, solid tumors and chronic inflammation.
+Added: Basis of Presentation and Principles of
+Added: Consolidation
+Added: The accompanying consolidated financial statements
+Added: of the Company have been prepared in accordance with Generally Accepted Accounting Principles (“US GAAP”) in the United States
+Added: of America and the rules of the Securities and Exchange Commission (“SEC”).
+Added: The consolidated financial statements herein have
+Added: been prepared in accordance with US GAAP and include the accounts of INmune Bio, its wholly-owned UK subsidiary, and its wholly-owned
+Added: Australia subsidiary (collectively, the “Company”).
+Added: All significant intercompany accounts and transactions have been eliminated.
+Added: NOTE 2 – LIQUIDITY
+Added: As of December 31, 2021, the Company had an accumulated
+Added: deficit of $ 63,715,000 and experienced losses since its inception.
+Added: Losses have principally occurred as a result of the substantial resources
+Added: required for research and development of the Company’s products, which included the general and administrative expenses associated
+Added: 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.
−Removed: meet its current and future obligations the Company has taken the following steps to capitalize the business and achieve its business
−Removed: During July 2020,
−Removed: the Company completed an underwritten public offering in which it sold 2,500,000 shares of common stock at a public offering
−Removed: price of $10.00 per share.
−Removed: The 2,500,000 shares sold included the full exercise of the underwriters’
−Removed: option to purchase
−Removed: 326,086 shares at a price of $10.00 per share.
−Removed: Aggregate net proceeds from the underwritten public offering were approximately
−Removed: $23.1 million, net of approximately $1.9 million in underwriting discounts and commissions and offering expenses.
−Removed: During April 2020,
−Removed: the Company entered into a sales agreement with BTIG, LLC (“BTIG”), as sales agent, to establish an At-The-Market
−Removed: (“ATM”) offering program.
−Removed: The Company was required to pay BTIG a commission of 3% of the gross proceeds from the
−Removed: sale of shares.
−Removed: The ATM program will remain in full force and effect until the earlier of the sale of all of the shares under
−Removed: the ATM program or the termination of the sales agreement by the Company or BTIG.
−Removed: From April 2020 through December 2020, the
−Removed: Company sold 178,600 shares of common stock at an average price of $5.45 per share for net proceeds of approximately $0.8
−Removed: During January and February 2021, the Company sold in aggregate 1,439,480 shares on common stock at an average price
−Removed: of $20.17 per share for net proceeds of approximately $28.4 million.
−Removed: During May 2019,
−Removed: the Company entered into a securities purchase agreement (“Purchase Agreement”) with Lincoln Park Capital Fund
−Removed: LLC (“Lincoln Park”), pursuant to which Lincoln Park has agreed to purchase from the Company up to an aggregate
−Removed: of $20.0 million of common stock of the Company (subject to certain limitations) from time to time over the term of the Purchase
−Removed: The extent we rely on Lincoln Park as a source of funding will depend on a number of factors including, the prevailing
−Removed: market price of our common stock and the extent to which we are able to secure working capital from other sources.
−Removed: date of issuance of this Annual Report on Form 10-K, the Company has already received approximately $1.3 million from the
−Removed: Purchase Agreement from the sale of 296,000 shares of common stock to Lincoln Park from the inception of the Purchase Agreement
−Removed: through the date of issuance of this Form 10-K, leaving the Company an additional $18.7 million to draw upon, subject to the
−Removed: Company’s compliance with the terms and conditions of the Purchase Agreement.
−Removed: it is difficult to predict the Company’s liquidity requirements, as of December 31, 2020, and based upon the Company’s
−Removed: current operating plan, the Company believes that it will have sufficient cash to meet its projected operating requirements for
−Removed: at least the next 12 months following the filing date of this Annual Report on Form 10-K based on the balance of cash available
−Removed: as of December 31, 2020 and the proceeds received from the Company’s ATM sales during January and February 2021.
−Removed: anticipates that it will continue to incur net losses for the foreseeable future as it continues the development of its clinical
−Removed: drug candidates and preclinical programs and incurs additional costs associated with being a public company.
−Removed: SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
−Removed: financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported
−Removed: amounts of assets, liabilities, revenue, and expenses.
−Removed: Actual results and outcomes may differ from management’s estimates
−Removed: and assumptions.
−Removed: and Uncertainties
−Removed: Company is subject to risks and uncertainties as a result of the COVID-19 pandemic.
−Removed: The extent of the impact of the COVID-19 pandemic
−Removed: on the Company’s business is highly uncertain and difficult to predict.
−Removed: Also, economies worldwide have also been negatively
−Removed: impacted by the COVID-19 pandemic, however policymakers around the globe have responded with fiscal policy actions to support
−Removed: the healthcare industry and economy as a whole.
−Removed: The magnitude and overall effectiveness of these actions remain uncertain.
−Removed: addition, the Company’s clinical trials have been affected by and may continue to be affected by the COVID-19 pandemic.
−Removed: Clinical site initiation and patient enrollment have and may continue to be delayed due to prioritization of hospital resources
−Removed: toward the COVID-19 pandemic.
−Removed: Some patients have not and others may not be able to comply with clinical trial protocols if quarantines
−Removed: impede patient movement or interrupt healthcare services.
−Removed: Similarly, the ability to recruit and retain patients and principal
−Removed: investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19, may adversely impact the
−Removed: Company’s clinical trial operations.
−Removed: severity of the impact of the COVID-19 pandemic on the Company’s business will depend on a number of factors, including,
−Removed: but not limited to, the duration and severity of the pandemic and the extent and severity of the impact on the Company’s
−Removed: service providers, suppliers, contract research organizations (“CROs”) and the Company’s clinical trials, all
−Removed: of which are uncertain and cannot be predicted.
−Removed: As of the date of issuance of Company’s financial statements, the extent
−Removed: to which the COVID-19 pandemic may materially impact the Company’s financial condition, liquidity or results of operations
−Removed: is uncertain.
−Removed: and Cash Equivalents
−Removed: The Company considers all highly liquid
−Removed: instruments purchased with an original maturity of three month s or less to be cash equivalents.
−Removed: The Company holds cash in banks
−Removed: in excess of Federal Deposit Insurance Corporation insurance limits.
−Removed: However, the Company believes risk of loss is minimal as the
−Removed: cash is held by large, highly-rated financial institutions.
−Removed: and Development Tax Incentive Receivable
−Removed: Company, through its wholly-owned subsidiary in Australia, participates in the Australian research and development tax incentive
−Removed: program, such that a percentage of our qualifying research and development expenditures are reimbursed by the Australian government,
−Removed: and such incentives are reflected as a reduction of research and development expense.
−Removed: The Australian research and development
−Removed: tax incentive is recognized when there is reasonable assurance that the incentive will be received, the relevant expenditure has
−Removed: been incurred and the amount of the consideration can be reliably measured.
−Removed: At each period end, management estimates the reimbursement
−Removed: available to the Company based on available information at the time.
−Removed: Company, through its wholly-owned subsidiary in the United Kingdom, participates in the research and development program provided
−Removed: by the United Kingdom tax relief program, such that a percentage of our qualifying research and development expenditures are reimbursed
−Removed: by the United Kingdom government, and such incentives are reflected as a reduction of research and development expense.
−Removed: Kingdom research and development tax incentive is recognized when there is reasonable assurance that the incentive will be received,
−Removed: the relevant expenditure has been incurred and the amount of the consideration can be reliably measured.
−Removed: At each period end, management
−Removed: estimates the reimbursement available to the Company based on available information at the time.
−Removed: Company capitalizes costs incurred in connection with in-process research and development purchased from others if the asset has
−Removed: alternative uses and such uses are not restricted under applicable license agreements;
−Removed: patent applications (principally legal
−Removed: fees), patent purchases, and trademarks related to its cell line as intangible assets.
−Removed: Acquired in-process research and development
−Removed: costs that do not have alternative uses are expensed as incurred.
−Removed: Amortization is initiated for acquired in-process research and
−Removed: development intangible assets when their useful lives have been determined.
−Removed: These acquired in-process research and development
−Removed: intangible assets are tested at least annually or when a triggering event occurs that could indicate a potential impairment.
−Removed: impairments of intangible assets were recognized during the years ended December 31, 2020 and 2019.
−Removed: and Diluted Loss per Share
−Removed: loss per share is computed by dividing net loss available to common shareholders by the weighted average number of outstanding
−Removed: common shares during the period.
−Removed: Diluted loss per share gives effect to all dilutive potential common shares outstanding during
−Removed: Dilutive loss per share excludes all potential common shares if their effect is anti-dilutive.
−Removed: For all periods presented,
−Removed: there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s
−Removed: net loss position.
−Removed: December 31, 2020, the Company had 3,457,000 potentially issuable shares of common stock upon the exercise of stock options and
−Removed: 1,955,922 potentially issuable shares of common stock upon the exercise of warrants.
−Removed: December 31, 2019, the Company had 3,417,000 potentially issuable shares of common stock upon the exercise of stock options and
−Removed: 1,660,874 potentially issuable shares of common stock upon the exercise of warrants.
−Removed: Company recognizes revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration
−Removed: the Company expects to receive in exchange for those goods or services.
−Removed: The Company recognizes revenue following the five-step
−Removed: model prescribed under ASC Topic 606:
−Removed: (1) identify contract(s) with a customer;
−Removed: (2) identify the performance obligations in the
+Added: To meet its current and future obligations the
+Added: Company has taken the following steps to capitalize the business and achieve its business plan:
+Added: ● During July 2021, the Company completed a registered direct
+Added: public offering in which it sold 1,818,182 shares of common stock to investors for estimated net proceeds of $ 36.9 million.
+Added: ● During June 2021, the Company entered into a loan and security agreement and drew down a $ 15.0 million
+Added: ● During March 2021, the Company entered into a sales agreement with
+Added: BTIG, LLC (“BTIG”), as agent, to establish an At-The-Market (“ATM”) offering of up to $ 45 million of common stock
+Added: (the “2021 ATM”), subject to certain limitations on the amount of common stock that may be offered and sold by the Company
+Added: set forth in the sales agreement.
+Added: The Company is required to pay BTIG a commission of 3 % of the gross proceeds from the sale of shares.
+Added: 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.
+Added: ● During April 2020, the Company entered into a sales agreement with
+Added: BTIG, as sales agent, to establish an ATM offering to sell up to $ 10.0 million of the Company’s common stock (the “2020 ATM”).
+Added: In August 2020, the sales agreement was amended whereby the aggregate offering was increased from $ 10.0 million to $ 30.0 million.
+Added: April 2020 through December 2020, the Company sold 178,600 shares of common stock at an average price of $ 5.45 per share for net proceeds
+Added: of approximately $ 0.8 million.
+Added: During the year ended December 31, 2021, the Company sold in aggregate 1,439,480 shares on common stock
+Added: at an average price of $ 20.17 per share for net proceeds of $ 28.4 million.
+Added: As of December 31, 2021, sales of our common stock pursuant
+Added: to the 2020 ATM have been completed.
+Added: Although it is difficult to predict the Company’s
+Added: liquidity requirements, as of December 31, 2021, and based upon the Company’s current operating plan, the Company believes that
+Added: it will have sufficient cash to meet its projected operating requirements for at least the next 12 months following the filing date of
+Added: this Annual Report on Form 10-K based on the balance of cash available as of December 31, 2021.
+Added: The Company anticipates that it will continue
+Added: to incur net losses for the foreseeable future as it continues the development of its clinical drug candidates and preclinical programs
+Added: and incurs additional costs associated with being a public company.
+Added: NOTE 3 – SUMMARY OF SIGNIFICANT
+Added: ACCOUNTING POLICIES
+Added: Use of Estimates
+Added: Preparing financial statements in conformity with
+Added: US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses.
+Added: Actual results and outcomes may differ from management’s estimates and assumptions.
+Added: Risks and Uncertainties
+Added: The Company is subject to risks and uncertainties
+Added: as a result of the COVID-19 pandemic.
+Added: The extent of the impact of the COVID-19 pandemic on the Company’s business is highly uncertain
+Added: and difficult to predict.
+Added: Also, economies worldwide have also been negatively impacted by the COVID-19 pandemic, however policymakers
+Added: around the globe have responded with fiscal policy actions to support the healthcare industry and economy as a whole.
+Added: The magnitude and
+Added: overall effectiveness of these actions remain uncertain.
+Added: In addition, the Company’s clinical trials
+Added: have been affected by and may continue to be affected by the COVID-19 pandemic.
+Added: Clinical site initiation and patient enrollment have and
+Added: may continue to be delayed due to prioritization of hospital resources toward the COVID-19 pandemic.
+Added: Some patients have not and others
+Added: may not be able to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services.
+Added: the ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened
+Added: exposure to COVID-19, may adversely impact the Company’s clinical trial operations.
+Added: The severity of the impact of the COVID-19 pandemic
+Added: on the Company’s business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic
+Added: and the extent and severity of the impact on the Company’s service providers, suppliers, contract research organizations (“CROs”)
+Added: and the Company’s clinical trials, all of which are uncertain and cannot be predicted.
+Added: As of the date of issuance of Company’s
+Added: financial statements, the extent to which the COVID-19 pandemic may materially impact the Company’s financial condition, liquidity
+Added: or results of operations is uncertain.
+Added: Cash and Cash Equivalents
+Added: The Company considers all highly liquid instruments purchased with
+Added: an original maturity of three months or less to be cash equivalents.
+Added: The Company holds cash in banks in excess of Federal Deposit Insurance
+Added: Corporation insurance limits.
+Added: However, the Company believes risk of loss is minimal as the cash is held by large, highly-rated financial
+Added: institutions.
+Added: Research and Development Tax Incentive Receivable
+Added: The Company, through its wholly-owned subsidiary
+Added: in Australia, participates in the Australian research and development tax incentive program, such that a percentage of our qualifying
+Added: research and development expenditures are reimbursed by the Australian government, and such incentives are reflected as a reduction of
+Added: research and development expense.
+Added: The Australian research and development tax incentive is recognized when there is reasonable assurance
+Added: that the incentive will be received, the relevant expenditure has been incurred and the amount of the consideration can be reliably measured.
+Added: At each period end, management estimates the reimbursement available to the Company based on available information at the time.
+Added: The Company, through its wholly-owned subsidiary
+Added: in the United Kingdom, participates in the research and development program provided by the United Kingdom tax relief program, such that
+Added: a percentage of our qualifying research and development expenditures are reimbursed by the United Kingdom government, and such incentives
+Added: are reflected as a reduction of research and development expense.
+Added: The United Kingdom research and development tax incentive is recognized
+Added: when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the amount of the
+Added: consideration can be reliably measured.
+Added: At each period end, management estimates the reimbursement available to the Company based on available
+Added: information at the time.
+Added: Intangible Assets
+Added: The Company capitalizes costs incurred in connection
+Added: with in-process research and development purchased from others if the asset has alternative uses and such uses are not restricted under
+Added: applicable license agreements;
+Added: patent applications (principally legal fees), patent purchases, and trademarks related to its cell line
+Added: as intangible assets.
+Added: Acquired in-process research and development costs that do not have alternative uses are expensed as incurred.
+Added: the assets are determined to have a finite life (upon completion of the development of the in-process research and development for its
+Added: DN-TNF platform), the useful life will be determined and the in-process research and development intangible assets will be amortized.
+Added: During the fourth quarter and if business factors
+Added: indicate more frequently, the Company performs an assessment of the qualitative factors affecting the fair value of our in-process research
+Added: and development.
+Added: If the qualitative assessment suggests that impairment is more likely than not, a quantitative analysis is performed.
+Added: The quantitative analysis involves a comparison of the fair value of the in-process research and development with the carrying amount.
+Added: If the carrying amount of the in-process research and development exceeds its fair value, an impairment loss is recognized in an amount
+Added: equal to that excess.
+Added: During the years ended December 31, 2020 and 2021, the Company performed a qualitative assessment of its in-process
+Added: research and development and determined that there was no impairment.
+Added: Basic and Diluted Loss per Share
+Added: Basic loss per share is computed by dividing net
+Added: loss available to common shareholders by the weighted average number of outstanding common shares during the period.
+Added: Diluted loss per
+Added: share gives effect to all dilutive potential common shares outstanding during the period.
+Added: Dilutive loss per share excludes all potential
+Added: common shares if their effect is anti-dilutive.
+Added: For all periods presented, there is no difference in the number of shares used to calculate
+Added: basic and diluted shares outstanding due to the Company’s net loss position.
+Added: At December 31, 2021, the Company had 4,097,000
+Added: potentially issuable shares of common stock upon the exercise of stock options and 93,866 potentially issuable shares of common stock
+Added: upon the exercise of warrants.
+Added: At December 31, 2020, the Company had 3,457,000
+Added: potentially issuable shares of common stock upon the exercise of stock options and 1,955,922 potentially issuable shares of common stock
+Added: upon the exercise of warrants.
+Added: Revenue Recognition
+Added: The Company recognizes revenue when the customer
+Added: obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange
+Added: for those goods or services.
+Added: The Company recognizes revenue following the five-step model prescribed under ASC Topic 606:
+Added: contract(s) with a customer;
+Added: (2) identify the performance obligations in the contract;
(3) determine the transaction price;
−Removed: (4) allocate the transaction price to the performance obligations in the contract;
−Removed: and (5) recognize revenues when (or as) the Company satisfies the performance obligations.
−Removed: The Company records the expenses related
−Removed: to revenue in research and development expense, in the periods such expenses were incurred.
−Removed: Company records deferred revenues when cash payments are received or due in advance of performance, including amounts which are
−Removed: Company’s 2020 revenue was from the sale of MSC’s to one third-party customer.
−Removed: The revenue was recognized when the
−Removed: MSC’s were shipped to the customer.
−Removed: Company utilizes the Black-Scholes option pricing model to estimate the fair value of stock option awards at the date of grant,
−Removed: which requires the input of highly subjective assumptions, including expected volatility and expected life.
−Removed: Changes in these inputs
−Removed: and assumptions can materially affect the measure of estimated fair value of our share-based compensation.
−Removed: These assumptions are
−Removed: subjective and generally require significant analysis and judgment to develop.
−Removed: When estimating fair value, some of the assumptions
−Removed: will be based on, or determined from, external data and other assumptions may be derived from our historical experience with stock-based
−Removed: payment arrangements.
−Removed: The appropriate weight to place on historical experience is a matter of judgment, based on relevant facts
−Removed: and circumstances.
+Added: the transaction price to the performance obligations in the contract;
+Added: and (5) recognize revenues when (or as) the Company satisfies the
+Added: performance obligations.
+Added: The Company records the expenses related to revenue in research and development expense, in the periods such
+Added: expenses were incurred.
+Added: The Company records deferred revenues when cash
+Added: payments are received or due in advance of performance, including amounts which are refundable.
+Added: The Company’s 2021 revenues were from the
+Added: sale of MSC’s to three customers.
+Added: The sales were recognized when the MSC’s were delivered to the customers.
+Added: The Company’s 2020 revenue was from the
+Added: sale of MSC’s to one customer.
+Added: The revenue was recognized when the MSC’s were delivered to the customer.
+Added: Stock-Based Compensation
+Added: The Company utilizes the Black-Scholes option
+Added: pricing model to estimate the fair value of stock option awards at the date of grant, which requires the input of highly subjective assumptions,
+Added: including expected volatility and expected life.
+Added: Changes in these inputs and assumptions can materially affect the measure of estimated
+Added: fair value of our share-based compensation.
+Added: These assumptions are subjective and generally require significant analysis and judgment to
+Added: When estimating fair value, some of the assumptions will be based on, or determined from, external data and other assumptions
+Added: may be derived from our historical experience with stock-based payment arrangements.
+Added: The appropriate weight to place on historical experience
+Added: is a matter of judgment, based on relevant facts and circumstances.
The Company accounts for forfeitures of stock options as they occur.
−Removed: and Development
−Removed: and development (“R&D”) costs are expensed as incurred.
−Removed: Research and development credits are recorded by the Company
−Removed: as a reduction of research and development costs.
−Removed: Major components of research and development costs include cash compensation,
−Removed: stock-based compensation, costs of preclinical studies, clinical trials and related clinical manufacturing, costs of drug development,
−Removed: costs of materials and supplies, facilities cost, overhead costs, regulatory and compliance costs, and fees paid to consultants
−Removed: and other entities that conduct certain research and development activities on the Company’s behalf.
−Removed: Company recognizes grants as contra research and development expense in the consolidated statement of operations on a systematic
−Removed: basis over the periods in which the entity recognizes as expenses the related costs for which the grants are intended to compensate.
−Removed: Company follows the liability method of accounting for income taxes.
−Removed: Under this method, deferred income tax assets and liabilities
−Removed: are recognized for the estimated tax consequences attributable to differences between the financial statement carrying values
−Removed: and their respective income tax basis (temporary differences).
−Removed: The effect on deferred income tax assets and liabilities of a change
−Removed: in tax rates is recognized in income in the period that includes the enactment date.
−Removed: Currency Translation
−Removed: Company’s financial statements are presented in the U.S.
−Removed: dollar (“$”), which is the Company’s reporting
−Removed: currency, while its functional currencies are the U.S.
−Removed: Dollar for its U.S.
−Removed: based operations, British Pound (“GBP”)
−Removed: for its United Kingdom-based operations and Australian Dollars (“AUD”) for its Australian-based operations.
−Removed: and liabilities are translated at the exchange rate on the balance sheet date, stockholders’
−Removed: equity is translated at historical
−Removed: rates and statement of operations items are translated at the weighted average exchange rate for the period.
−Removed: The resulting translation
−Removed: adjustments are reported under other comprehensive income.
−Removed: Gains and losses resulting from the translations of foreign currency
−Removed: transactions and balances are reflected in the statement of operations and comprehensive income (loss).
−Removed: Adopted Accounting Pronouncements
−Removed: were various accounting standards and interpretations issued recently, none of which are expected to a have a material impact
−Removed: on the Company´s consolidated financial position, operations, or cash flows.
−Removed: Company has evaluated all transactions through the financial statement issuance date for subsequent disclosure consideration.
−Removed: RESEARCH AND DEVELOPMENT ACTIVITY
−Removed: 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
−Removed: in R&D subject to certain requirements.
−Removed: The Company’s UK subsidiary submits R&D tax credit requests annually for
−Removed: research and development expenses incurred.
−Removed: At December 31, 2020 and 2019, the Company recorded a research and development tax
−Removed: credit receivable of $833,024 and $395,850, respectively for R&D expenses incurred in the UK.
−Removed: During the years ended December
−Removed: 31, 2020 and 2019, the Company received $305,593 and $443,929 of R&D tax credit reimbursements, respectively from the UK.
−Removed: 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
−Removed: in R&D subject to certain requirements.
−Removed: The Company’s Australian subsidiary submits R&D tax credit requests annually
−Removed: for research and development expenses incurred.
−Removed: At December 31, 2020 and 2019, the Company recorded a research and development
−Removed: tax credit receivable of $853,041 and $172,289, respectively, for R&D expenses incurred in Australia.
−Removed: During the years ended
−Removed: December 31, 2020 and 2019, the Company received $178,029 and $410,857 of R&D tax credit reimbursements, respectively from
−Removed: License Agreement
−Removed: October 3, 2017, the Company entered into a license agreement (“Xencor License Agreement”) with Xencor, Inc.
−Removed: (“Xencor”),
−Removed: which has discovered and developed a proprietary biological molecule that inhibits soluble tumor necrosis factor.
−Removed: the license agreement, Xencor granted the Company an exclusive worldwide, royalty-bearing license in licensed patent rights, licensed
−Removed: know-how and licensed materials (as defined in the license agreement) to make, develop, use, sell and import any pharmaceutical
−Removed: product that comprises, contains, or incorporates Xencor’s proprietary protein that inhibits soluble tumor necrosis factor
−Removed: (or all modifications, formulations and variants of the licensed protein that specifically bind soluble tumor necrosis factor)
−Removed: alone or in combination with one or more active ingredients, in any dosage or formulation (“Licensed Products”).
−Removed: Company refers to this licensed protein as DN-TNF and the Company has labeled it as XPro1595 for the Company’s Alzheimer’s
−Removed: and Treatment Resistant Depression indications, Quellor for the COVID-19 indication and LIVNate for the NASH indication.
−Removed: believes the protein has numerous other medical applications.
−Removed: Such additional alternative applications of the technology are available
−Removed: under the license agreement.
−Removed: In connection with the license agreement, the Company paid Xencor a one-time non-creditable and non-refundable
−Removed: 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.
−Removed: the Company issued Xencor fully vested warrants with a fair value of $4,193,000 to purchase an additional number of shares of
−Removed: common stock equal to 10% of the fully diluted company shares immediately following such purchase.
−Removed: The warrants have an exercise
−Removed: price based on a valuation of the Company at $100,000,000 and expire on October 3, 2023.
−Removed: The aggregate purchase price for the
−Removed: full exercise of the option is $10,000,000 which purchase price shall be pro-rated for any partial exercise of the Warrant.
−Removed: August 2018, the Company entered into a First Amendment to Stock Issuance Agreement.
−Removed: Pursuant to the amendment, the purchase price
−Removed: for the additional shares may only be paid by cash.
−Removed: Company recorded $16,514,000 for the acquisition of intangible assets for the in-process research and development as the fair
−Removed: value of the cash, stock and warrants on the date of the License Agreement acquisition in accordance with Accounting Standards
−Removed: Codification 730 –
Research and Development
−Removed: The Company has the license rights to pursue alternative applications
−Removed: of the technology as part of its future development plans.
−Removed: Company also agreed to pay Xencor a royalty on Net Sales of all Licensed Products in a given calendar year, which are payable
−Removed: on a country-by- country and licensed product by licensed product basis until the date that is the later of (a) the expiration
−Removed: of the last to expire valid claim covering such Licensed Product in such country or (b) ten years following the first sale to
−Removed: a third party of the licensed product in such country.
−Removed: The Company had no sales of Licensed Products during 2020.
−Removed: the Xencor License Agreement, the Company also agreed to pay Xencor a percentage of any sublicensing revenue that it receives.
+Added: Research and development (“R&D”)
+Added: costs are expensed as incurred.
+Added: Research and development credits are recorded by the Company as a reduction of research and development
+Added: Major components of research and development costs include cash compensation, stock-based compensation, costs of preclinical studies,
+Added: clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead
+Added: costs, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development
+Added: activities on the Company’s behalf.
+Added: The Company recognizes grants as contra research
+Added: and development expense in the consolidated statement of operations on a systematic basis over the periods in which the entity recognizes
+Added: as expenses the related costs for which the grants are intended to compensate.
+Added: The Company follows the liability method of accounting
+Added: for income taxes.
+Added: Under this method, deferred income tax assets and liabilities are recognized for the estimated tax consequences attributable
+Added: to differences between the financial statement carrying values and their respective income tax basis (temporary differences).
+Added: on deferred income tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment
+Added: Foreign Currency Translation
+Added: The Company’s financial statements are presented
+Added: dollar (“$”), which is the Company’s reporting currency, while its functional currencies are the U.S.
+Added: based operations, British Pound (“GBP”) for its United Kingdom-based operations and Australian Dollars (“AUD”)
+Added: for its Australian-based operations.
+Added: All assets and liabilities are translated at the exchange rate on the balance sheet date, stockholders’
+Added: equity is translated at historical rates and statement of operations items are translated at the weighted average exchange rate for the
+Added: The resulting translation adjustments are reported under other comprehensive income.
+Added: Gains and losses resulting from the translations
+Added: of foreign currency transactions and balances are reflected in the statement of operations and comprehensive loss.
+Added: Recently Adopted Accounting Pronouncements
+Added: There were various accounting standards and interpretations
+Added: issued recently, none of which are expected to a have a material impact on the Company´s consolidated financial position, operations,
+Added: or cash flows.
+Added: Reclassifications
+Added: Certain amounts from the prior period have been
+Added: adjusted to conform to the current period presentation.
+Added: Subsequent Events
+Added: The Company has evaluated all transactions through
+Added: the financial statement issuance date for subsequent disclosure consideration.
+Added: NOTE 4 – RESEARCH AND DEVELOPMENT
+Added: According to UK tax law, the Company is allowed
+Added: 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.
+Added: The Company’s UK subsidiary submits R&D tax credit requests annually for research and development expenses incurred.
+Added: 31, 2021 and 2020, the Company recorded a research and development tax credit receivable of $ 3,319,000 and $ 833,000 , respectively for
+Added: R&D expenses incurred in the UK.
+Added: During the years ended December 31, 2021 and 2020, the Company received $ 814,000 and $ 306,000 of
+Added: R&D tax credit reimbursements, respectively from the UK.
+Added: According to AUS tax law, the Company is allowed
+Added: an R&D tax credit that reduces a company’s tax bill in AUS for expenses incurred in R&D subject to certain requirements.
+Added: The Company’s Australian subsidiary submits R&D tax credit requests annually for research and development expenses incurred.
+Added: At December 31, 2021 and 2020, the Company recorded a research and development tax credit receivable of $ 1,594,000 and $ 853,000 , respectively,
+Added: for R&D expenses incurred in Australia.
+Added: During the years ended December 31, 2021 and 2020, the Company received $ 1,296,000 and $ 178,000
+Added: of R&D tax credit reimbursements, respectively from Australia.
License Agreement
−Removed: October 29, 2015, the Company entered into an exclusive license agreement (the “INKmune License Agreement”) with Immune
−Removed: Ventures, LLC (“Immune Ventures”).
−Removed: Pursuant to the INKmune License Agreement, the Company was granted exclusive worldwide
−Removed: rights to the patents, including rights to incorporate any improvements or additions to the patents that may be developed in the
−Removed: In consideration for the patent rights, the Company agreed to the following milestone payments (of which none have been
−Removed: met as of December 31, 2020):
+Added: On October 3, 2017, the Company entered into a
+Added: license agreement (“Xencor License Agreement”) with Xencor, Inc.
+Added: (“Xencor”), which has discovered and developed
+Added: a proprietary biological molecule that inhibits soluble tumor necrosis factor.
+Added: During June 2021, the Company entered into the First Amendment
+Added: to License Agreement.
+Added: Pursuant to the license agreement, Xencor granted the Company an exclusive worldwide, royalty-bearing license in
+Added: licensed patent rights, licensed know-how and licensed materials (as defined in the license agreement) to make, develop, use, sell and
+Added: import any pharmaceutical product that comprises, contains, or incorporates Xencor’s proprietary protein known as “XPro”
+Added: that inhibits soluble tumor necrosis factor (or all modifications, formulations and variants of the licensed protein that specifically
+Added: bind soluble tumor necrosis factor) alone or in combination with one or more active ingredients, in any dosage or formulation (“Licensed
+Added: The Company believes the protein has numerous medical applications.
+Added: Such additional alternative applications of the
+Added: technology are available under the Xencor License Agreement.
+Added: In connection with the Xencor License Agreement, the Company paid Xencor
+Added: 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
+Added: a fair value of $ 12,221,000 .
+Added: In addition, the Company issued Xencor fully vested warrants with a fair value of $ 4,193,000 to purchase
+Added: an additional number of shares of common stock equal to 10 % of the fully diluted company shares immediately following such purchase, which
+Added: warrant has since been cancelled (see the description below).
+Added: The aggregate purchase price for the full exercise of the option was $ 10,000,000 .
+Added: The Company recorded $ 16,514,000 for the acquisition
+Added: 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
+Added: License Agreement acquisition in accordance with Accounting Standards Codification 730 – Research and Development .
+Added: has the license rights to pursue alternative applications of the technology as part of its future development plans.
+Added: The Company also agreed to pay Xencor a royalty
+Added: 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
+Added: product basis until the date that is the later of (a) the expiration of the last to expire valid claim covering such Licensed Product
+Added: in such country or (b) ten years following the first sale to a third party of the licensed product in such country.
+Added: Under the Xencor License Agreement, the Company
+Added: also agreed to pay Xencor a percentage of any sublicensing revenue that it receives.
+Added: On June 10, 2021, the Company and Xencor entered
+Added: into an Option Cancellation Agreement whereby Xencor terminated its warrant to purchase 10 % of the fully diluted shares of the Company
+Added: in exchange for a cash payment of $ 15,000,000 and 192,533 shares of the Company’s common stock with a fair value of $ 3,300,000 based
+Added: on the market price of the common stock as of June 10, 2021, which the Company issued in June 2021.
+Added: The Company filed a registration statement
+Added: covering the resale of these shares during September 2021 and agreed to keep the registration statement continuously effective until all
+Added: such shares cease to be outstanding or otherwise cease to be registrable securities as defined in the Option Cancellation Agreement.
+Added: Company charged the cash consideration paid to Xencor to enter into the Option Cancellation Agreement to equity as the fair value of the
+Added: warrant immediately prior to the Option Cancellation Agreement was greater than the consideration paid to Xencor.
+Added: INKmune License Agreement
+Added: On October 29, 2015, the Company entered into
+Added: an exclusive license agreement (the “INKmune License Agreement”) with Immune Ventures, LLC (“Immune Ventures”).
+Added: Pursuant to the INKmune License Agreement, the Company was granted exclusive worldwide rights to the patents, including rights to incorporate
+Added: any improvements or additions to the patents that may be developed in the future.
+Added: In consideration for the patent rights, the Company
+Added: agreed to the following milestone payments:
+Added: (in thousands)
Each Phase I initiation
3 unchanged sentences
Each NDA/EMA awarded
−Removed: 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.
+Added: During July 2021, the Company initiated a Phase
+Added: I clinical trial using INKmune and the Company paid Immune Ventures a $ 25,000 milestone payment.
+Added: In addition, the Company agreed to pay the licensor
+Added: a royalty of 1 % of net sales during the life of each patent granted to the Company.
The License is owned by Immune Ventures.
−Removed: RJ Tesi, the Company’s President and a member of our Board of Directors, David
−Removed: Moss, its Chief Financial Officer and Treasurer and Mark Lowdell, its Chief Scientific Officer, are the owners of Immune Ventures.
−Removed: As of December 31, 2020 and December 31, 2019, no sales had occurred under this license.
−Removed: term of the agreement began on October 29, 2015 and, if not terminated sooner pursuant to the agreement, ends on a country-by-country
−Removed: basis on the date of the expiration of the last to expire patent rights where patent rights exists.
−Removed: Upon the termination of the
−Removed: agreement we shall have a fully paid up, perpetual, royalty-free license without further obligation to Immune Ventures.
−Removed: The agreement
−Removed: can be terminated by Immune Ventures if, after 60 days from the Company’s receipt of notice that the Company has not made
−Removed: a payment under the agreement, and the Company still does not make this payment.
−Removed: On July 20, 2018, the parties amended the
−Removed: agreement under which the Company was required achieve milestones pursuant to the agreement.
−Removed: On October 30, 2020, the parties
−Removed: executed an additional amendment to the agreement under which the Company is required to achieve the following milestones:
−Removed: of Phase 1 clinical or equivalent trials by October 29, 2021
−Removed: of Phase II clinical trials or equivalent by October 29, 2023
−Removed: of Phase III clinical trials or equivalent by October 29, 2025
−Removed: of NDA or equivalent by October 29, 2026 or equivalent
−Removed: the Company doesn’t achieve the above milestones, it is required to negotiate in good faith with Immune Ventures to determine
−Removed: how it can either remedy the failure or achieve an alternate development.
−Removed: If the Company fails to make any required efforts, or
−Removed: if the efforts do not remedy the situation within 60 days of written notice by Immune Ventures, then Immune Ventures may provide
−Removed: notice to terminate the license or convert it to a non-exclusive license.
−Removed: of Pittsburg License Agreement
−Removed: October 3, 2017, the Company entered into an Assignment and Assumption Agreement with Immune Ventures related to intellectual
−Removed: property licensed from the University of Pittsburgh.
−Removed: Pursuant to the Assignment and Assumption Agreement (“Assignment Agreement”),
−Removed: Immune Ventures assigned all of its rights, obligations and liabilities under an Exclusive License Agreement between the University
−Removed: of Pittsburgh –
−Removed: Of the Commonwealth System of Higher Education (“Licensor”) and Immune Ventures to INmune Bio
−Removed: (“Licensee”), (the “PITT Agreement”).
−Removed: Consideration
−Removed: under the PITT Agreement includes:
−Removed: (i) annual maintenance fees, (ii) royalty payments based on the sale of products making use
−Removed: of the licensed technology, and (iii) milestone payments.
−Removed: maintenance fees under the PITT Agreement include:
+Added: the Company’s President and a member of our Board of Directors, David Moss, its Chief Financial Officer and Treasurer and Mark Lowdell,
+Added: its Chief Scientific Officer, are the owners of Immune Ventures.
+Added: As of December 31, 2021 and December 31, 2020, no sales had occurred
+Added: under this license.
+Added: The term of the agreement began on October 29,
+Added: 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
+Added: last to expire patent rights where patent rights exists.
+Added: Upon the termination of the agreement we shall have a fully paid up, perpetual,
+Added: royalty-free license without further obligation to Immune Ventures.
+Added: The agreement can be terminated by Immune Ventures if, after 60 days
+Added: from the Company’s receipt of notice that the Company has not made a payment under the agreement, and the Company still does not
+Added: make this payment.
+Added: On July 20, 2018, the parties amended the agreement under which the Company was required achieve milestones pursuant
+Added: to the agreement.
+Added: On October 30, 2020, the parties executed an additional amendment to the agreement under which the Company is required
+Added: to achieve the following milestones:
+Added: Initiation of Phase II clinical trials or equivalent
+Added: by October 29, 2023
+Added: Initiation of Phase III clinical trials or equivalent
+Added: by October 29, 2025
+Added: Filing of NDA or equivalent by October 29, 2026
+Added: or equivalent
+Added: If the Company doesn’t achieve the above
+Added: milestones, it is required to negotiate in good faith with Immune Ventures to determine how it can either remedy the failure or achieve
+Added: an alternate development.
+Added: If the Company fails to make any required efforts, or if the efforts do not remedy the situation within 60 days
+Added: of written notice by Immune Ventures, then Immune Ventures may provide notice to terminate the license or convert it to a non-exclusive
+Added: University of Pittsburg License Agreement
+Added: On October 3, 2017, the Company entered into an
+Added: Assignment and Assumption Agreement with Immune Ventures related to intellectual property licensed from the University of Pittsburgh.
+Added: Pursuant to the Assignment and Assumption Agreement (“Assignment Agreement”), Immune Ventures assigned all of its rights,
+Added: obligations and liabilities under an Exclusive License Agreement between the University of Pittsburgh – Of the Commonwealth System
+Added: of Higher Education (“Licensor”) and Immune Ventures to INmune Bio (“Licensee”), (the “PITT Agreement”).
+Added: Consideration under the PITT Agreement includes:
+Added: (i) annual maintenance fees, (ii) royalty payments based on the sale of products making use of the licensed technology, and (iii) milestone
+Added: Annual maintenance fees under the PITT Agreement
$5,000 due June 26 of each year 2020-2022;
$10,000 due on June 26 of each year 2023-2024;
−Removed: and $25,000 due on June 26 of each year 2025 and annually thereafter until first commercial sale.
−Removed: The Company had no
−Removed: amounts owed pursuant to the PITT Agreement as of December 31, 2020.
+Added: and $25,000 due on June 26 of each
+Added: year 2025 and annually thereafter until first commercial sale.
+Added: The Company had no amounts owed pursuant to the PITT Agreement as of December
+Added: (in thousands)
June 26 of each year 2020-2022
1 unchanged sentence
June 26 of each year 2025 until first commercial sale
−Removed: first commercial sale of a product making use of the licensed technology under the PITT Agreement, the Licensee is required to
−Removed: pay royalties equal to 2.5% of Net Sales each calendar quarter.
−Removed: under the PITT Agreement the Licensee is required to make milestone payments as follows:
+Added: Upon first commercial sale of a product making
+Added: 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
+Added: There were no commercial sales of product making use of the licensed
+Added: technology under the PITT Agreement in 2021.
+Added: Moreover, under the PITT Agreement the Licensee
+Added: is required to make milestone payments as follows:
+Added: (in thousands)
Each Phase I initiation
1 unchanged sentence
First commercial sale of product making use of licensed technology
−Removed: Company made a $50,000 milestone payment in March 2019 pursuant to the PITT Agreement as a result of a Phase I initiation.
−Removed: PITT Agreement expires upon the earlier of:
−Removed: (i) expiration of the last claim of the Patent Rights forming the subject matter of
−Removed: the PITT Agreement;
−Removed: or (ii) the date that is 20 years from the effective date of the agreement (June 26, 2037).
−Removed: Licensee may terminate the PITT Agreement upon 3 months prior written notice provided all payments under the license are current.
−Removed: The Licensor may terminate the PITT Agreement upon written notice if:
−Removed: (i) Licensee defaults as to performance of material obligations
−Removed: which have not been cured within 60 days after receiving written notice;
−Removed: or (ii) Licensee ceases to carry out its business, becomes
−Removed: bankrupt or insolvent, applies for or consents to the appointment of a trustee, receiver or liquidator of its assets or seeks
−Removed: relief under any law for the aid of debtors.
−Removed: College London License Agreement –
−Removed: July 19, 2019, the Company entered into license agreement with UCL Business PLC (“UCLB”) with a ten (10) year term.
−Removed: Pursuant to the license agreement, the Company acquired an exclusive license (and a right to sub-license) to the technology and
−Removed: know-how relating to an isolation and commercial scale expansion methodology of GMP grade human umbilical cord mesenchymal stem/stromal
−Removed: cells (“MSC”).
−Removed: exchange for the license agreement, the Company paid UCLB an initial license fee of approximately $10,000 and shall pay annual
−Removed: licensing fees of approximately $13,000 per year for the remaining term of the agreement beginning in July 2020.
−Removed: The Company will
−Removed: pay UCLB a royalty of 3-3.5%of the net sales value (as defined in the agreement) of all licensed products sold or used by the
−Removed: In the event the Company sub-licenses the technology and know-how, the Company will pay UCLB a royalty of 12 percent
−Removed: of consideration (cash or non-cash) received by the Company in relation to the development or sub-licensing of any of the technology
−Removed: and know-how.
−Removed: The Company had no amounts owed to UCLB as of December 31, 2020.
−Removed: May 2019, the Company signed a sublease agreement with a related party for office space in La Jolla, California, which serves
−Removed: as the new headquarters of the Company.
−Removed: The lease has a 61-month term, which corresponds to the lease term of the lessor.
−Removed: lessor is CTI Clinical Trial & Consulting Services (“CTI”).
−Removed: CTI is majority-owned by a member of the Company’s
−Removed: Board of Directors.
−Removed: The lessor may extend its lease for an additional 5 years, and, if it does, the Company may also extend its
−Removed: sublease for 5 years.
−Removed: The Company did not include the option to extend in the calculation of the lease liabilities as such extension
−Removed: is not reasonably certain to occur.
−Removed: Variable lease costs for the Company’s lease consists of operating expenses for the
−Removed: Below is a summary of the Company’s right-of-use assets and liabilities:
−Removed: Right-of-use asset –
−Removed: related party
−Removed: Operating lease, current liability –
−Removed: related party
−Removed: Long-term operating lease liability –
−Removed: related party
+Added: The Company made a $ 50,000 milestone payment in
+Added: March 2019 pursuant to the PITT Agreement as a result of a Phase I initiation.
+Added: The PITT Agreement expires upon the earlier of:
+Added: (i) expiration
+Added: of the last claim of the Patent Rights forming the subject matter of the PITT Agreement;
+Added: or (ii) the date that is 20 years from the effective
+Added: date of the agreement (June 26, 2037).
+Added: The Licensee may terminate the PITT Agreement
+Added: upon 3 months prior written notice provided all payments under the license are current.
+Added: The Licensor may terminate the PITT Agreement
+Added: upon written notice if:
+Added: (i) Licensee defaults as to performance of material obligations which have not been cured within 60 days after
+Added: receiving written notice;
+Added: or (ii) Licensee ceases to carry out its business, becomes bankrupt or insolvent, applies for or consents to
+Added: the appointment of a trustee, receiver or liquidator of its assets or seeks relief under any law for the aid of debtors.
+Added: NOTE 5 – LEASE
+Added: In May 2019, the Company signed a sublease agreement
+Added: with a related party for office space in La Jolla, California, which served as the former headquarters of the Company.
+Added: The lease has a
+Added: 61 -month term, which corresponds to the lease term of the lessor.
+Added: The lessor is CTI Clinical Trial & Consulting Services (“CTI”).
+Added: CTI is majority-owned by a member of the Company’s Board of Directors.
+Added: During 2021, the Company moved its corporate headquarters
+Added: to Boca Raton, Florida.
+Added: The Company intends to sublease its office space in La Jolla.
+Added: In September 2021, the Company signed a lease
+Added: with a third party for office space in Boca Raton, Florida.
+Added: The lease agreement has a 64 -month term and commenced during the fourth
+Added: quarter of 2021.
+Added: Below is a summary of the Company’s right-of-use
+Added: assets and liabilities:
+Added: (in thousands, except years and rate)
+Added: Right-of-use asset (La Jolla lease)
+Added: Right-of-use asset (Boca Raton lease)
+Added: Operating lease, current liability (La Jolla lease)
+Added: Operating lease, current liability (Boca Raton lease)
+Added: Long-term operating lease liability (La Jolla lease)
+Added: Long-term operating lease liability (Boca Raton lease)
Total lease liability
1 unchanged sentence
Weighted-average discount rate
−Removed: the years ended December 31, 2020 and 2019, the Company recognized $52,428 and $33,204, respectively, in operating lease expense,
−Removed: which is included in general and administrative expenses in the Company’s consolidated statement of operations.
−Removed: RELATED PARTY TRANSACTIONS
−Removed: December 31, 2020 and 2019, the Company owed UCL Consultants Limited (“UCL”) $33,664 and $9,379, respectively, in
−Removed: connection with medical research performed on behalf of the Company.
−Removed: During the years ending December 31, 2020 and 2019, the Company
−Removed: paid UCL $334,738 and $349,071, respectively, for medical research performed on behalf of the Company.
−Removed: UCL is a wholly owned subsidiary
−Removed: of the University of London.
−Removed: The Company’s Chief Scientific and Manufacturing Officer is a professor at the University of
−Removed: December 31, 2020 and 2019, the Company owed CTI $0 and $280,723, respectively, for medical research performed on behalf of the
−Removed: During the years ending December 31, 2020 and 2019, the Company paid CTI $126,850 and $1,071,126, respectively, for medical
+Added: NOTE 6 – RELATED PARTY TRANSACTIONS
+Added: At December 31, 2021 and 2020, the Company owed
+Added: UCL Consultants Limited (“UCL”) $ 10,000 and $ 34,000 , respectively, in connection with medical research performed on behalf
+Added: of the Company.
+Added: During the years ended December 31, 2021 and 2020, the Company paid UCL $ 218,000 and $ 335,000 , respectively, for medical
research performed on behalf of the Company.
−Removed: During the years ended December 31, 2020 and 2019, the Company paid CTI $25,392 and
−Removed: $49,305, respectively, pursuant to its sublease agreement with CTI.
+Added: UCL is a wholly owned subsidiary of the University of London.
+Added: The Company’s Chief Scientific
+Added: and Manufacturing Officer is a professor at the University of London.
+Added: year ended December 31, 2021 and 2020, the Company paid CTI $ 0 and $ 127,000 , respectively, for medical research performed on behalf
+Added: of the Company.
+Added: During the year ended December 31, 2020, the Company recorded a capital contribution of $ 216,000 for the forgiveness
+Added: of certain accounts payable due to CTI.
+Added: During the years ended December 31, 2021 and 2020, the Company paid CTI $ 38,000 and $ 25,000 , respectively,
+Added: pursuant to its sublease agreement with CTI.
+Added: year ended December 31, 2021, the Company engaged AmplifyBio to perform certain medical research on behalf of the Company.
+Added: AmplifyBio is on the Board of Directors of the Company.
+Added: At December 31, 2021, the Company owed AmplifyBio $ 70,000 .
+Added: No amounts were paid
+Added: to AmplifyBio during 2021.
+Added: The Company had no transactions with AmplifyBio during 2020.
+Added: 10, 2021, the Company entered into a Loan and Security Agreement (the “Term Loan”) with Silicon Valley Bank and SVB Innovation
+Added: Credit Fund VIII, L.P., together (the “Lenders”).
+Added: The Term Loan provides for a $ 15.0 million term loan, of which
+Added: the Company borrowed the entire amount on June 10, 2021, and is secured by the Company’s assets.
+Added: The Term Loan also provides
+Added: 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
+Added: of the Lenders.
+Added: paid the Lenders $ 47,000 to access the term loan, which has been included as a component of the debt discount and is amortized to
+Added: interest expense over the term of the loan.
+Added: The term loan and debt discount are as follows as of December 31, 2021:
+Added: (in thousands)
+Added: debt discount and financing costs, net
+Added: current portion
+Added: Long-term debt
+Added: For the year ended December 31,
+Added: 2021, the Company recognized interest expense of $ 985,000 related to the Term Loan.
+Added: loan repayment schedule provided for interest only payments beginning on July 1, 2021, and continuing for 12 months, followed by monthly
+Added: principal and interest payments, starting on July 1, 2022 and continuing through the maturity date of January 1, 2025.
+Added: During August
+Added: 2021, the Lenders extended the interest-only period for one year due to the Company achieving an equity milestone as fully defined
+Added: in the Term Loan.
+Added: As a result of achieving the equity milestone, monthly principal and interest payments begin on July 1, 2023.
+Added: All outstanding
+Added: principal and accrued and unpaid interest will be due and payable on the maturity date.
+Added: The Term Loan provides for an annual interest
+Added: 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 %.
+Added: At December 31, 2021, the interest rate was 7.75 %.
+Added: Loan includes a final payment fee equal to 6.5 % of the original principal amount borrowed payable on the earlier of the repayment
+Added: of the loan in full and the maturity date.
+Added: The Company has the option to prepay the outstanding balance of the term loans in full,
+Added: subject to a prepayment premium of (i) 3 % of the original principal amount borrowed for any prepayment on or prior to the first anniversary
+Added: of the loan, (ii) 2 % of the original principal amount borrowed for any prepayment after the first anniversary and on or before the
+Added: second anniversary of the loan or (iii) 1 % of the original principal amount borrowed for any prepayment after the second anniversary
+Added: of the loan but before the maturity date.
+Added: repayment of the $ 15.0 million Term loan principal is as follows as of December 31, 2021:
+Added: (in thousands,
+Added: except years)
+Added: occurrence of certain events, including but not limited to the Company’s failure to satisfy its payment obligations under the Term
+Added: Loan, the breach of certain of its other covenants under the Term Loan, or the occurrence of a material adverse change, the Lenders will
+Added: have the right, among other remedies, to declare all principal and interest immediately due and payable, and will have the right to receive
+Added: the final payment fee and, if the payment of principal and interest is due prior to maturity, the applicable prepayment fee.
+Added: was in compliance with its debt covenants at December 31, 2021.
+Added: NOTE 8 – STOCKHOLDERS’ EQUITY
+Added: Common Stock – At the Market Offerings
During the year ended December 31, 2020, the Company
−Removed: recorded a capital contribution of $215,761 for the forgiveness of certain accounts payable due to CTI.
−Removed: STOCKHOLDERS’
−Removed: Public Offering
−Removed: February 2019, the Company completed its initial public offering in which the Company sold 1,020,820 shares of its common stock
−Removed: for gross proceeds of $8,166,560 (net proceeds of $7,251,142).
−Removed: and May 2019 Stock Sale
−Removed: April and May 2019, the Company sold 522,212 shares of its common stock to certain investors for cash proceeds of $4,727,879,
−Removed: of which the Company’s CEO purchased 11,100 shares for $119,325 of cash and the Company’s CFO purchased 5,000 shares
−Removed: for $53,550 of cash.
−Removed: May 15, 2019, the Company entered into both a securities purchase agreement and registration rights agreement with Lincoln Park
−Removed: Capital Fund, LLC (“Lincoln Park”).
−Removed: Under the terms and subject to the conditions of the securities purchase agreement,
−Removed: the Company has the right to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to $20.0 million in shares of
−Removed: the Company’s common stock, subject to certain limitations, from time to time, over the 24-month period that commenced on
−Removed: May 15, 2019.
−Removed: During May 2019, the Company issued 70,000 shares of the Company’s common stock to Lincoln Park as consideration
−Removed: for Lincoln Park’s commitment to purchase shares of the Company’s common stock under the agreement, and 30,000 shares
−Removed: of common stock were sold to Lincoln Park in an initial purchase for an aggregate gross purchase price of $300,000 ($230,000 net
−Removed: of offering costs).
−Removed: the year ended December 31, 2020, the Company issued 196,000 shares of its common stock to Lincoln Park for $1,002,644 of cash.
−Removed: At December 31, 2020, Lincoln Park is obligated to purchase up to $18.7 million worth of the Company’s common stock.
−Removed: contemplated by the securities purchase agreement with Lincoln Park, and so long as the closing price of the Company’s common
−Removed: stock exceeds $3.50 per share, then the Company may, subject to the terms and conditions of the Agreement, direct Lincoln Park,
−Removed: at its sole discretion to purchase up to 20,000 shares of its common stock on any business day.
−Removed: The purchase price will be based
−Removed: on the market prices of the common stock at the time of such purchases as set forth in the securities purchase agreement.
−Removed: addition to regular purchases, the Company may, subject to the terms and conditions of the Agreement, also direct Lincoln Park
−Removed: to purchase other amounts as accelerated purchases or as additional purchases if the closing sale price of the common stock exceeds
−Removed: certain threshold prices as set forth in the purchase agreement.
−Removed: There are no trading volume requirements or restrictions under
−Removed: the purchase agreement nor any upper limits on the price per share that Lincoln Park must pay for shares of common stock.
−Removed: and retirement of common stock
−Removed: January 2020, the Company purchased and cancelled 220,000 shares of its common stock from a shareholder in exchange for $1,012,000
−Removed: Immediately following the purchase, the investor owned less than 10% of the outstanding common stock of the Company.
−Removed: Stock –
−Removed: At the Market Offering
−Removed: April 2020, the Company entered into a sales agreement with BTIG, LLC (“BTIG”), as sales agent, to establish an At-The-Market
−Removed: (“ATM”) offering program.
−Removed: The sales agreement with BTIG was subsequently amended during August 2020.
−Removed: The Company was
−Removed: required to pay BTIG a commission of 3% of the gross proceeds from the sale of shares.
−Removed: The ATM program will remain in full force
−Removed: and effect until the earlier of the sale of all of the shares under the ATM program or the termination of the sales agreement
−Removed: by the Company or BTIG.
−Removed: From the inception of the agreement through December 31, 2020, the Company sold 178,600 shares of common
−Removed: stock at an average price of $5.45 per share for gross proceeds of $972,879 (net proceeds of $812,828) and the Company paid BTIG
−Removed: commissions and fees of $79,187.
−Removed: Stock Offering
−Removed: July 2020, the Company completed an underwritten public offering in which it sold 2,500,000 shares of common stock at a public
−Removed: offering price of $10.00 per share.
−Removed: The 2,500,000 shares sold included the full exercise of the underwriters’
−Removed: purchase 326,086 shares at a price of $10.00 per share.
−Removed: Aggregate net proceeds from the underwritten public offering were $23.1
−Removed: million, net of approximately $1.9 million in underwriting discounts and commissions and offering expenses.
−Removed: Stock Issued for Services
−Removed: July 2020, the Company granted a consultant 50,000 fully vested warrants with a 5-year term, of which 25,000 warrants had an exercise
−Removed: price of $5.50 per share and 25,000 warrants had an exercise price of $10.00 per share.
−Removed: The fair value of these warrants was $356,874
−Removed: based on the Black-Scholes Option Pricing Model and was recorded within general and administrative expense.
−Removed: The assumptions used
−Removed: for these warrants consist of the exercise prices, expected dividends of 0%, expected volatility of 111.67% based on the trading
−Removed: history of similar companies, risk-free rate of 0.30% based on the applicable US Treasury bill rate and an expected life of 5.0
−Removed: During July 2020, the Company issued the consultant 20,000 shares of common stock and cancelled the 50,000 warrants.
−Removed: 20,000 shares were issued from the Company’s 2019 Incentive Stock Plan and had a fair value of approximately $230,000 based
−Removed: on the market value of the Company’s common stock on the grant date.
−Removed: The Company accounted for the exchange of the warrants
−Removed: for shares of common stock as a modification and recorded no additional expense in connection with the exchange as the fair value
−Removed: of warrants exceeded the fair value of the shares issued.
−Removed: Stock Issuable
−Removed: Seaboard Consulting Agreement
−Removed: May 16, 2018, the Company entered into a consulting agreement with Pacific Seaboard Investments Ltd.
−Removed: (“Pacific Seaboard”)
−Removed: for corporate governance, compliance services regarding the filing of a listing application and assist with activities related
−Removed: to its initial public offering.
−Removed: In consideration of the consultant’s services, the Company agreed to issue 600,000 shares
−Removed: of its restricted common stock.
−Removed: Pursuant to this agreement, the Company recorded $4,626,000 as common stock issuable for the 600,000
−Removed: shares of common stock to be issued.
−Removed: During June 2019, the Company issued 400,000 shares of its common stock to Pacific Seaboard,
−Removed: whereby the Company was initially required to issue 600,000 shares to Pacific Seaboard, but subsequently received a waiver from
−Removed: Pacific Seaboard during April 2019 permanently waiving the last 200,000 shares owed.
−Removed: November 2016, the Company entered into a settlement agreement whereby the Company agreed to issue 33,335 shares of the Company’s
−Removed: common stock to an individual to settle a claim in full.
−Removed: The obligation was recorded as common stock issuable of $50,000 as of
−Removed: December 31, 2019.
−Removed: During December 2020, the Company issued the 33,335 shares.
−Removed: September 2019, upon obtaining stockholder approval, the Company implemented the 2019 Stock Incentive Plan (2019 Stock Plan).
−Removed: The 2019 Stock Plan provides for the grant of incentive stock options, non-statutory stock options, restricted stock and other
−Removed: stock-based compensation awards to employees, officers, directors and consultants of the Company.
−Removed: The administration of the 2019
−Removed: Stock Plan is under the general supervision of the compensation committee of the board of directors.
−Removed: As of December 31, 2019,
−Removed: the Company had options outstanding to purchase 1,785,000 shares of its common stock, pursuant to the 2019 Stock Plan.
−Removed: options issued pursuant to the 2019 Stock Plan had an aggregated fair value of $5,500,616 that was calculated using the Black-Scholes
−Removed: option-pricing model.
+Added: issued and sold 178,600 shares of common stock at an average price of $ 5.45 per share under the 2020 ATM agreement.
+Added: The aggregate net
+Added: proceeds were approximately $ 0.8 million after BTIG’s commission and other offering expenses.
+Added: During the year ended December 31, 2021, the Company
+Added: sold 1,439,480 shares of its common stock at an average price of $ 20.17 per share under the 2020 ATM agreement.
+Added: The aggregate net proceeds
+Added: were approximately $ 28.4 million after BTIG’s commission and other offering expenses.
+Added: During the year ended December 31, 2021, the Company
+Added: sold 713,192 shares of its common stock at an average price of $ 21.73 per share under the 2021 ATM agreement.
+Added: The aggregate net proceeds
+Added: were approximately $ 14.9 million after BTIG’s commission and other offering expenses.
+Added: Direct Offering
+Added: 2021, the Company completed a registered direct offering whereby the Company sold 1,818,182 shares of its common stock to investors
+Added: for gross proceeds of $ 38.0 million (net proceeds of $ 36.9 million).
+Added: Underwritten Stock Offering
+Added: During July 2020, the Company completed an underwritten
+Added: public offering in which it sold 2,500,000 shares of common stock at a public offering price of $ 10.00 per share.
+Added: The 2,500,000 shares
+Added: sold included the full exercise of the underwriters’ option to purchase 326,086 shares at a price of $ 10.00 per share.
+Added: net proceeds from the underwritten public offering were $ 23.1 million, net of approximately $ 1.9 million in underwriting discounts and
+Added: commissions and offering expenses.
+Added: of shares to Xencor
+Added: 10, 2021, the Company and Xencor entered into an Option Cancellation Agreement whereby the Company issued 192,533 shares of
+Added: its common stock to Xencor (See Note 4).
+Added: On May 15, 2019, the Company entered into both
+Added: a securities purchase agreement and registration rights agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”).
+Added: the terms and subject to the conditions of the securities purchase agreement, the Company had the right to sell to Lincoln Park, and Lincoln
+Added: Park was obligated to purchase, up to $20.0 million in shares of the Company’s common stock, subject to certain limitations, over
+Added: the 24-month period that commenced on May 15, 2019.
+Added: During the year ended December 31, 2020, the Company issued 196,000 shares of its
+Added: common stock to Lincoln Park for approximately $1.0 million of cash.
+Added: During April 2021, the Company terminated the
+Added: securities purchase agreement with Lincoln Park.
+Added: Purchase and retirement of common stock
+Added: During January 2020, the Company purchased and
+Added: cancelled 220,000 shares of its common stock from a shareholder in exchange for $ 1,012,000 of cash.
+Added: Immediately following the purchase,
+Added: the investor owned less than 10 % of the outstanding common stock of the Company.
+Added: Common Stock Issued for Services
+Added: During July 2020, the Company granted a consultant
+Added: 50,000 fully vested warrants with a 5 -year term, of which 25,000 warrants had an exercise price of $ 5.50 per share and 25,000 warrants
+Added: had an exercise price of $ 10.00 per share.
+Added: The fair value of these warrants was $ 356,874 based on the Black-Scholes Option Pricing Model
+Added: and was recorded within general and administrative expense.
+Added: The assumptions used for these warrants consist of the exercise prices, expected
+Added: dividends of 0 %, expected volatility of 111.67 % based on the trading history of similar companies, risk-free rate of 0.30 % based on the
+Added: applicable US Treasury bill rate and an expected life of 5.0 years.
+Added: During July 2020, the Company issued the consultant 20,000 shares
+Added: of common stock and cancelled the 50,000 warrants.
+Added: The 20,000 shares were issued from the Company’s 2019 Incentive Stock Plan and
+Added: had a fair value of approximately $ 230,000 based on the market value of the Company’s common stock on the grant date.
+Added: accounted for the exchange of the warrants for shares of common stock as a modification and recorded no additional expense in connection
+Added: with the exchange as the fair value of warrants exceeded the fair value of the shares issued.
+Added: In 2016, the Company entered into a settlement
+Added: agreement whereby the Company agreed to issue 33,335 shares of the Company’s common stock to an individual to settle a claim in
+Added: During 2020, the Company issued the 33,335 shares.
+Added: Stock options
+Added: During September 2020, the Company granted an
+Added: employee an option to purchase 40,000 shares of its common stock pursuant to the 2019 Incentive Stock Plan.
+Added: The stock options vest over
+Added: four years and had a fair value of $ 339,731 that was calculated using the Black-Scholes option-pricing model.
+Added: Variables used in the Black-Scholes
+Added: option-pricing model include:
+Added: (1) discount rate of 0.46 % based on the applicable US Treasury bill rate (2) expected life of 6.25 years,
+Added: (3) expected volatility of approximately 106 % based on the trading history of similar companies, and (4) zero expected dividends.
+Added: During 2021, the Company granted various employees,
+Added: consultants and directors options to purchase 823,000 shares of common stock pursuant to the 2021, 2019 and 2017 Incentive Stock Plans.
+Added: The stock options vest over zero to four years and had a fair value of $ 14,027,000 that was calculated using the Black-Scholes option-pricing
Variables used in the Black-Scholes option-pricing model include:
−Removed: (1) discount rate of 1.71%-1.76% based
−Removed: on the applicable US Treasury bill rates (2) expected life of 6.0 –
−Removed: 10.0 years, (3) expected volatility of approximately
−Removed: 94% based on the trading history of similar companies, and (4) zero expected dividends.
−Removed: September 2020, the Company granted an employee options to purchase 40,000 shares of its common stock pursuant to the 2019 Incentive
−Removed: The stock options had a fair value of $339,731 that was calculated using the Black-Scholes option-pricing model.
−Removed: used in the Black-Scholes option-pricing model include:
−Removed: (1) discount rate of 0.46% based on the applicable US Treasury bill rate
−Removed: (2) expected life of 6.25 years, (3) expected volatility of approximately 106% based on the trading history of similar companies,
−Removed: and (4) zero expected dividends.
−Removed: following table summarizes stock option activity:
−Removed: Weighted-average
+Added: (1) discount rate of 0.78 -1.
+Added: 49 %% based on the applicable US Treasury
+Added: bill rate (2) expected life of 6.00 - 10.00 years, (3) expected volatility of approximately 105 %- 114 % based on the trading history of similar
+Added: companies, and (4) zero expected dividends.
+Added: The following table summarizes stock option activity:
+Added: (in thousands, except share and per share amounts)
Outstanding at January 1, 2020
8 unchanged sentences
Exercisable at December 31, 2021
−Removed: the years ended December 31, 2020 and 2019, the Company recognized stock-based compensation expense of $2,755,130 and $4,049,333,
−Removed: respectively, related to stock options.
−Removed: As of December 31, 2020, there was $4,077,489 of total unrecognized compensation cost
−Removed: related to non-vested stock options which is expected to be recognized over a weighted-average period of 2.00 years.
−Removed: connection with the Company’s initial public offering in February 2019, the Company issued warrants to the placement agents
−Removed: to purchase 40,982 shares of the Company’s common stock at an exercise price of $9.60 per common share, which warrants are
−Removed: exercisable until December 19, 2023.
−Removed: During July 2020, 6,147 of these warrants were exercised on a cashless basis in exchange
−Removed: for 2,400 shares of the Company’s common stock.
−Removed: At December 31, 2020, 34,835 of these warrants are outstanding and the intrinsic
−Removed: value is $265,443.
−Removed: October 2017, in connection with the Xencor License Agreement, the Company issued fully vested warrants to purchase an additional
−Removed: number of shares of common stock equal to 10% of the fully diluted Company shares immediately following such purchase.
−Removed: These warrants had an intrinsic value of $22,535,812 as of December 31, 2020.
−Removed: June 30, 2017, the Company issued fully vested warrants with a maturity date of June 30, 2022 and an exercise price of $1.50 to
−Removed: purchase 31,667 shares of the Company’s common stock to a third party in conjunction with common stock sold for cash.
−Removed: warrants had an intrinsic value of $497,805 as of December 31, 2020.
−Removed: Compensation by Class of Expense
−Removed: following summarizes the components of stock-based compensation expense in the consolidated statements of operations for the years
−Removed: ended December 31, 2020 and 2019 respectively:
+Added: received $ 1,135,000 in cash proceeds from exercises of stock options during the year ended December 31, 2021.
+Added: During the years ended December 31, 2021 and 2020,
+Added: the Company recognized stock-based compensation expense of $ 4,796,000 and $ 2,755,000 , respectively, related to stock options.
+Added: As of December
+Added: 31, 2021, there was $ 13,308,000 of total unrecognized compensation cost related to non-vested stock options which is expected to be recognized
+Added: over a weighted-average period of 2.52 years.
+Added: issued 45,386 warrants to the Company’s lenders upon obtaining its loan in June 2021.
+Added: The warrants have a 10-year term
+Added: and an exercise price of $ 14.05 .
+Added: The warrants have a fair value of approximately $ 0.6 million that was calculated using the Black-Scholes
+Added: option-pricing model.
+Added: Variables used in the Black-Scholes option-pricing model include:
+Added: (1) discount rate of 1.45 % based on the applicable
+Added: US Treasury bill rate (2) expected life of 10.0 years, (3) expected volatility of approximately 103 % based on the trading
+Added: history of similar companies, and (4) zero expected dividends.
+Added: At December 31, 2021, the intrinsic value of these warrants is
+Added: In connection
+Added: with the Company’s initial public offering in February 2019, the Company issued warrants to the placement agents to purchase the
+Added: Company’s common stock at an exercise price of $ 9.60 per common share, which warrants are exercisable until December 19, 2023.
+Added: the year ended December 31, 2021, 6,147 of these warrants were exercised on a cashless basis in exchange for 3,758 shares
+Added: of common stock.
+Added: At December 31, 2021, 28,688 of these warrants are outstanding and the intrinsic value is $ 17,000 .
+Added: 30, 2017, the Company issued fully vested warrants to purchase 31,667 shares of the Company’s common stock to a third
+Added: party in conjunction with the common stock sold for cash.
+Added: The warrants have a $ 1.50 exercise price and expire on June 30, 2022 .
+Added: During the year ended December 31, 2021, 11,875 of these warrants were exercised for cash proceeds of $ 18,000 .
+Added: At December 31,
+Added: 2021, 19,792 of these warrants are outstanding, with an intrinsic value of $ 172,000 .
+Added: Stock-based Compensation by Class of Expense
+Added: The following summarizes the components of stock-based
+Added: compensation expense in the consolidated statements of operations for the years ended December 31, 2021 and 2020 respectively:
Research and development
General and administrative
−Removed: Rights Agreement
−Removed: On December 30, 2020, the Board of Directors
−Removed: (the “Board”) of the Company approved and adopted a Rights Agreement, dated as of December 30, 2020, by and between
−Removed: the Company and VStock Transfer, LLC, as rights agent, pursuant to which the Board declared a dividend of one preferred share purchase
−Removed: right (each, a “Right”) for each outstanding share of the Company’s common stock held by stockholders as of the
−Removed: close of business on January 11, 2021.
−Removed: When exercisable, each right initially would represent the right to purchase from the Company
−Removed: one one-thousandth of a share of a newly designated series of preferred stock, Series A Junior Participating Preferred Stock, par
−Removed: 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
−Removed: Preferred Share, subject to adjustment.
−Removed: Subject to various exceptions, the Rights become exercisable in the event any person (excluding
−Removed: certain exempted or grandfathered persons) becomes the beneficial owner of twenty percent or more of the Company’s common
−Removed: stock without the approval of the Board.
−Removed: The Rights are scheduled to expire on December 30, 2021.
−Removed: Preferred Stock
−Removed: In 2020, the Company
−Removed: designated 45,000 shares of its preferred stock with par value of $0.001 per share as Series A Junior Participating
+Added: Shareholder Rights Agreement
+Added: On December 30, 2020, the Board of Directors (the
+Added: “Board”) of the Company approved and adopted a Rights Agreement, dated as of December 30, 2020, by and between the Company
+Added: and VStock Transfer, LLC, as rights agent, pursuant to which the Board declared a dividend of one preferred share purchase right (each,
+Added: a “Right”) for each outstanding share of the Company’s common stock held by stockholders as of the close of business
+Added: on January 11, 2021.
+Added: When exercisable, each right initially would represent the right to purchase from the Company one one-thousandth
+Added: of a share of a newly designated series of preferred stock, Series A Junior Participating Preferred Stock, par value $0.001 per share,
+Added: of the Company, at an exercise price of $300.00 per one one-thousandth of a Series A Junior Participating Preferred Share, subject to
+Added: Subject to various exceptions, the Rights become exercisable in the event any person (excluding certain exempted or grandfathered
+Added: persons) becomes the beneficial owner of twenty percent or more of the Company’s common stock without the approval of the Board.
+Added: The Rights Agreement was scheduled to expire on December 30, 2021 but was extended until December 30, 2022 by the Board.
Preferred Stock
−Removed: The remaining 9,955,000 shares of preferred stock with par value of $0.001 remain undesignated.
−Removed: None of the preferred shares were issued and outstanding at December 31, 2020 and 2019.
−Removed: provision for income taxes consists of the following components:
+Added: In 2020, the Company designated 45,000 shares
+Added: of its preferred stock with par value of $ 0.001 per share as Series A Junior Participating Preferred Stock.
+Added: The remaining 9,955,000 shares
+Added: of preferred stock with par value of $ 0.001 remain undesignated.
+Added: None of the preferred shares were issued and outstanding at December 31,
+Added: 2021 and 2020.
+Added: NOTE 9– INCOME TAXES
+Added: The provision for income taxes consists of the
+Added: following components:
Current expense (benefit)
3 unchanged sentences
Net deferred taxes
−Removed: reconciliation of income tax benefit computed using the federal statutory income tax rate to the Company’s tax expense is
+Added: A reconciliation of income tax benefit computed
+Added: using the federal statutory income tax rate to the Company’s tax expense is as follows:
+Added: (in thousands, except percentage)
Federal tax benefit at statutory rate (21%)
−Removed: $ (2,540,824 )
−Removed: $ (1,612,444 )
Stock-based compensation
2 unchanged sentences
Research credits
−Removed: Forgiveness of stock payable
Return to provision adjustment
1 unchanged sentence
Income tax benefit
−Removed: principal components of deferred tax assets and liabilities consist of the following at December 31, 2020 and 2019, respectively:
+Added: The principal components of deferred tax assets
+Added: and liabilities consist of the following at December 31, 2021 and 2020, respectively:
+Added: (in thousands)
Deferred tax assets
5 unchanged sentences
Net deferred tax assets
−Removed: At December 31, 2020, the Company had a
−Removed: federal net operating loss carryforward of approximately $10.5 million.
−Removed: The net operating loss carryforwards for 2017 will begin
−Removed: to expire in the year ending December 31, 2037.
+Added: At December 31, 2021, the Company had a federal
+Added: net operating loss carryforward of approximately $ 15.7 million.
+Added: The net operating loss carryforwards for 2017 will begin to expire in
+Added: the year ending December 31, 2037 .
The net operating loss carryforwards starting in 2018 have no expiration.
−Removed: in the valuation allowance was $1,638,407 during the year ended December 31, 2020.
−Removed: Company recognizes uncertain tax positions in accordance with ASC 740 on the basis of evaluating whether it is more likely than
−Removed: not that the tax positions will be sustained upon examination by tax authorities.
−Removed: For those tax positions that meet the more-likely-than
−Removed: not recognition threshold, we recognize the largest amount of tax benefit that is more than 50 percent likely to be realized upon
−Removed: ultimate settlement.
−Removed: As of December 31, 2020, and 2019, the Company has no significant uncertain tax positions.
−Removed: There are no unrecognized
−Removed: tax benefits included on the balance sheet that would, if recognized, impact the effective tax rate.
−Removed: The Company does not anticipate
−Removed: there will be a significant change in unrecognized tax benefits within the next 12 months.
−Removed: COLLABORATIVE AGREEMENTS
−Removed: 2019, the Company was awarded a $1,000,000 grant from the Alzheimer’s Association to advance XPro1595, a novel therapy targeting
−Removed: neuroinflammation as a cause of Alzheimer’s disease.
−Removed: The endowment was awarded under the Part the Cloud to RESCUE grant.
−Removed: During the year ended December 31, 2020 and 2019, the Company received $150,000 and $850,000, respectively, related to the grant,
−Removed: which the Company recorded as a reduction of research and development expense.
−Removed: As of December 31, 2020, the Company has received
−Removed: $1,000,000 of cash proceeds from the Alzheimer’s Association and no additional amounts are available to the Company pursuant
−Removed: to this grant.
−Removed: the year ended December 31, 2020, the Company was awarded a $500,000 grant from the Amyotrophic Lateral Sclerosis (“ALS”)
−Removed: 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
−Removed: to protect against ALS model phenotypes in vivo.
−Removed: During the year ended December 31, 2020, the Company received $300,000 of cash
−Removed: proceeds pursuant to this grant which the Company recorded as deferred liabilities.
−Removed: During the year ended December 31, 2020, the
−Removed: Company recorded $177,704 as a reduction of deferred liabilities as a result of incurring costs related to the ALS grant.
−Removed: December 31, 2020, the Company recorded $122,296 as deferred liabilities in the consolidated balance sheet related to the ALS
−Removed: September 2020, the Company was awarded a grant of up to $2.9 million from the National Institutes of Health (“NIH”).
−Removed: The grant will support a Phase 2 study of XPro1595 in patients with treatment resistant depression.
−Removed: As of December 31, 2020, the
−Removed: Company has not received any proceeds pursuant to this grant.
−Removed: SUBSEQUENT EVENTS
−Removed: During January and February 2021, the Company
−Removed: sold 1,439,480 shares of its common stock for aggregate gross proceeds of $29.0 million (net proceeds of $28.4 million) under the
−Removed: The Company paid BTIG commissions and fees of $581,500 in connection with the sale of these shares.
−Removed: January 2021, the Company granted 198,549 stock options with an exercise price of $24.82 to executives and directors of the Company
−Removed: which vest over 3-4 years.
−Removed: The fair value of these options was approximately $4.2 million.
−Removed: During February 2021, the Company received
−Removed: $100,000 of cash proceeds pursuant to its grant from the ALS Association.
−Removed: Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
+Added: The Company’s gross deferred tax assets
+Added: of $ 6.8 million and $ 3.5 million at December 31, 2021 and 2020, respectively, primarily consist of net operating loss carryforwards for
+Added: income tax purposes.
+Added: A valuation allowance is required to be recorded when it is not more likely than not that some portion or all of
+Added: the net deferred tax assets will be realized.
+Added: Since the Company cannot be assured of generating taxable income and thereby realizing the
+Added: net deferred tax assets, a full valuation allowance has been recorded.
+Added: The change in the valuation allowance was $ 3,245,000 during
+Added: the year ended December 31, 2021.
+Added: The Company recognizes uncertain tax positions
+Added: 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
+Added: examination by tax authorities.
+Added: For those tax positions that meet the more-likely-than not recognition threshold, we recognize the largest
+Added: amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement.
+Added: As of December 31, 2021, and 2020,
+Added: the Company has no significant uncertain tax positions.
+Added: There are no unrecognized tax benefits included on the balance sheet that would,
+Added: if recognized, impact the effective tax rate.
+Added: The Company does not anticipate there will be a significant change in unrecognized tax benefits
+Added: within the next 12 months.
+Added: NOTE 10 – COLLABORATIVE AGREEMENTS
+Added: During the year ended December 31, 2020, the Company
+Added: was awarded a $500,000 grant from the Amyotrophic Lateral Sclerosis (“ALS”) Association to fund a study of the efficacy of
+Added: XPro to reverse ALS in vitro and to fund a study of the efficacy of XPro to protect against ALS model phenotypes in vivo.
+Added: During the years
+Added: ended December 31, 2021 and 2020, the Company received $ 200,000 , and $ 300,000 , respectively of cash proceeds pursuant to this grant which
+Added: the Company recorded as deferred liabilities.
+Added: The Company records costs incurred related to the ALS study as a reduction of the deferred
+Added: As of December 31, 2021, the Company has $ 257,000 recorded as deferred liabilities related to the ALS grant.
+Added: During September 2020, the Company was awarded
+Added: a grant of up to $2.9 million from the National Institutes of Health (“NIH”).
+Added: The grant will support a Phase 2 study of XPro
+Added: in patients with treatment resistant depression.
+Added: As of December 31, 2021, the Company has not received any proceeds pursuant to this grant.
+Added: 11 – COMMITMENTS AND CONTINGENCIES
+Added: the Company signed a sublease agreement with a related party for office space in La Jolla, California.
+Added: The lease has a 61-month term,
+Added: which corresponds to the lease term of the lessor.
+Added: The lessor is CTI.
+Added: During September
+Added: 2021, the Company signed a lease agreement with a third party for office space in Boca Raton, Florida.
+Added: The lease agreement has a 64-month
+Added: term and commenced during the fourth quarter of 2021.
+Added: Future minimum payments pursuant
+Added: to the leases are as follows:
+Added: (in thousands,
+Added: except years)
+Added: Total lease payments
+Added: imputed interest
+Added: Present value of future lease payments
+Added: operating lease, current liabilities
+Added: Long-term operating lease liabilities
+Added: During the years ended December 31, 2021 and 2020,
+Added: the Company recognized $ 102,000 and $ 52,000 , respectively, in operating lease expense, which is included in general and administrative
+Added: expenses in the Company’s consolidated statement of operations.
+Added: is subject to claims and suits that arise from time to time in the ordinary course of our business.
+Added: Although management currently believes
+Added: that resolving claims against the Company, individually or in aggregate, will not have a material adverse impact in the Company’s
+Added: consolidated financial statements, these matters are subject to inherent uncertainties and management’s view of these matters may
+Added: change in the future.
+Added: Changes in and Disagreements with Accountants
+Added: on Accounting and Financial Disclosure
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.