−Removed: Financial Statements and Supplementary
−Removed: INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: Financial Statements and Supplementary Data
+Added: TO CONSOLIDATED FINANCIAL STATEMENTS
AUDITED FINANCIAL STATEMENTS:
−Removed: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB ID Number 688 )
+Added: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB ID Number 688 ) F-2
CONSOLIDATED BALANCE SHEETS AS OF DECEMBER 31, 2023 AND 2022 F-3
−Removed: CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE YEARS ENDED DECEMBER 31,
−Removed: 2022 AND 2021 F-4
−Removed: CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY FOR THE YEARS ENDED DECEMBER
−Removed: 31, 2022 AND 2021 F-5
+Added: CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE YEARS ENDED DECEMBER 31, 2023 AND 2022 F-4
+Added: CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY FOR THE YEARS ENDED DECEMBER 31, 2023 AND 2022 F-5
CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED DECEMBER 31, 2023 AND 2022 F-6
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS F-7
−Removed: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
−Removed: To the Stockholders and Board of Directors of
−Removed: INmune Bio, Inc.
−Removed: Boca Raton, Florida
−Removed: Opinion on the Financial Statements
−Removed: We have audited the accompanying consolidated
−Removed: balance sheets of INmune Bio, Inc.
−Removed: (the “Company”) as of December 31, 2022 and 2021, the related consolidated statements of
−Removed: operations and comprehensive loss, changes in stockholders’ equity and cash flows for each of the two years in the period ended
−Removed: December 31, 2022, and the related notes (collectively referred to as the “financial statements”).
−Removed: In our opinion, the financial
−Removed: statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results
−Removed: of its operations and its cash flows for each of the two years in the period ended December 31, 2022, in conformity with accounting principles
−Removed: generally accepted in the United States of America
−Removed: Basis for Opinion
−Removed: These financial statements are the responsibility
−Removed: of the Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s financial statements based on our audits.
−Removed: are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are
−Removed: required to be independent with respect to the Company in accordance with the U.S.
−Removed: federal securities laws and the applicable rules and
−Removed: regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: We conducted our audits in accordance with the
−Removed: standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial
−Removed: statements are free of material misstatement, whether due to error or fraud.
−Removed: The Company is not required to have, nor were we engaged
−Removed: to perform, an audit of its internal control over financial reporting.
−Removed: As part of our audits, we are required to obtain an understanding
−Removed: of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
−Removed: control over financial reporting.
+Added: OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
+Added: the Stockholders and Board of Directors of
+Added: Raton, Florida
+Added: on the Financial Statements
+Added: We have audited the accompanying consolidated balance sheets of INmune
+Added: (the “Company”) as of December 31, 2023 and 2022, the related consolidated statements of operations and comprehensive
+Added: loss, changes in stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2023, and the related
+Added: notes (collectively referred to as the “financial statements”).
+Added: In our opinion, the financial statements present fairly, in
+Added: all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its
+Added: cash flows for each of the two years in the period ended December 31, 2023, in conformity with accounting principles generally accepted
+Added: in the United States of America
+Added: Explanatory Paragraph – Going Concern
+Added: The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern.
+Added: fully described in Note 2, the Company has incurred significant net losses, negative cash flows from its operating activities and requires
+Added: additional funds to sustain its operations.
+Added: These conditions raise substantial doubt about the Company's ability to continue as a going
+Added: Management's plans in regard to these matters are also described in Note 2.
+Added: The consolidated financial statements do not include
+Added: any adjustments that might result from the outcome of this uncertainty.
+Added: financial statements are the responsibility of the Company’s management.
+Added: Our responsibility is to express an opinion on the Company’s
+Added: financial statements based on our audits.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board
+Added: (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S.
+Added: securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
+Added: conducted our audits in accordance with the standards of the PCAOB.
+Added: Those standards require that we plan and perform the audits to obtain
+Added: reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
+Added: is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
+Added: As part of our audits,
+Added: we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
+Added: on the effectiveness of the Company’s internal control over financial reporting.
Accordingly, we express no such opinion.
−Removed: Our audits included performing procedures to assess
−Removed: the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
−Removed: to those risks.
−Removed: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
−Removed: Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
−Removed: the overall presentation of the financial statements.
−Removed: We believe that our audits provide a reasonable basis for our opinion.
−Removed: /s/ Marcum llp
−Removed: We have served as the Company’s auditor since 2017.
−Removed: Houston, Texas
−Removed: March 2, 2023
−Removed: INMUNE BIO INC.
−Removed: CONSOLIDATED BALANCE SHEETS
−Removed: (In thousands, except share and per share amounts)
−Removed: December 31, 2022
−Removed: December 31, 2021
+Added: audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error
+Added: or fraud, and performing procedures that respond to those risks.
+Added: Such procedures included examining, on a test basis, evidence regarding
+Added: the amounts and disclosures in the financial statements.
+Added: Our audits also included evaluating the accounting principles used and significant
+Added: estimates made by management, as well as evaluating the overall presentation of the financial statements.
+Added: We believe that our audits
+Added: provide a reasonable basis for our opinion.
+Added: have served as the Company’s auditor since 2017.
+Added: BALANCE SHEETS
+Added: thousands, except share and per share amounts)
CURRENT ASSETS
5 unchanged sentences
TOTAL CURRENT ASSETS
−Removed: Operating lease – right of use assets
+Added: Operating lease – right of use asset
Acquired in-process research and development intangible assets
−Removed: LIABILITIES AND STOCKHOLDERS’ EQUITY
+Added: LIABILITIES, REDEEMABLE COMMON STOCK AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
2 unchanged sentences
Deferred liabilities
−Removed: Current portion of long-term debt
−Removed: Operating lease, current liabilities
+Added: Current portion of long-term debt, net
+Added: Operating lease, current liability
TOTAL CURRENT LIABILITIES
−Removed: Long-term debt, less debt discount
−Removed: Long-term operating lease liabilities
+Added: Long-term debt, net
+Added: Long-term operating lease liability
Accrued liability – long-term
1 unchanged sentence
COMMITMENTS AND CONTINGENCIES
+Added: Redeemable common stock, $ 0.001 par value;
+Added: 75,697 and 0 shares issued and outstanding, respectively (Note 9)
STOCKHOLDERS’ EQUITY
Preferred stock, $ 0.001 par value, 10,000,000 shares authorized, 0 shares issued and outstanding
−Removed: Common stock, $ 0.001 par value, 200,000,000 shares authorized,
−Removed: 17,945,995 and 17,843,303 shares issued and outstanding, respectively
+Added: Common stock, $ 0.001 par value, 200,000,000 shares authorized, 17,950,776 and 17,945,995 shares issued and outstanding, respectively
Additional paid-in capital
−Removed: Accumulated other comprehensive (loss) income
+Added: Accumulated other comprehensive loss
Accumulated deficit
TOTAL STOCKHOLDERS’ EQUITY
−Removed: TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
−Removed: See accompanying notes to these consolidated financial
−Removed: INMUNE BIO INC.
−Removed: CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
+Added: TOTAL LIABILITIES, REDEEMABLE COMMON STOCK AND STOCKHOLDERS’ EQUITY
+Added: accompanying notes to these consolidated financial statements.
+Added: STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
+Added: THE YEARS ENDED DECEMBER 31, 2023 AND 2022
thousands, except share and per share amounts)
12 unchanged sentences
Total comprehensive loss
−Removed: See accompanying notes to these consolidated financial
−Removed: INMUNE BIO INC.
−Removed: CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
−Removed: (In thousands, except share amounts)
+Added: accompanying notes to these consolidated financial statements.
+Added: STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
+Added: THE YEARS ENDED DECEMBER 31, 2023 AND 2022
+Added: thousands, except share amounts)
Comprehensive
3 unchanged sentences
Issuance of common stock for cash, net
−Removed: Settlement of Xencor warrant for cash and common stock
−Removed: Warrants issued to lenders as debt inducement
−Removed: Exercise of warrants
−Removed: Exercise of stock options
+Added: Exercise of warrants for cash
Stock-based compensation
2 unchanged sentences
Issuance of common stock for cash
−Removed: Exercise of warrants for cash
+Added: Reclassification to redeemable common stock
+Added: Cashless exercise of warrants
Stock-based compensation
1 unchanged sentence
Balance as of December 31, 2023
−Removed: See accompanying notes to these consolidated financial
−Removed: INMUNE BIO INC.
−Removed: CONSOLIDATED STATEMENTS OF CASH FLOWS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
−Removed: (In thousands)
+Added: $ ( 121,022 )
+Added: accompanying notes to these consolidated financial statements.
+Added: STATEMENTS OF CASH FLOWS
+Added: THE YEARS ENDED DECEMBER 31, 2023 AND 2022
CASH FLOWS FROM OPERATING ACTIVITIES:
12 unchanged sentences
Accrued liability – long-term
−Removed: Operating lease liabilities
+Added: Operating lease liability
Net cash used in operating activities
−Removed: CASH FROM INVESTING ACTIVITIES
−Removed: Cash paid to Xencor to settle warrant for acquired research and development intangible assets
−Removed: Net cash used in investing activities
CASH FLOWS FROM FINANCING ACTIVITIES:
−Removed: Net proceeds from the issuance of debt
Net proceeds from sale of common stock
−Removed: Net proceeds from the exercise of stock options
+Added: Repayment of debt
Net proceeds from the exercise of warrants
−Removed: Net cash provided by financing activities
+Added: Net cash (used in) provided by financing activities
Impact on cash from foreign currency translation
−Removed: NET (DECREASE) INCREASE IN CASH
+Added: NET DECREASE IN CASH
CASH AT BEGINNING OF YEAR
3 unchanged sentences
Cash paid for interest expense
−Removed: NONCASH INVESTING AND FINANCING ACTIVITIES:
−Removed: Common stock issued to Xencor to settle warrant issued for acquired research and development intangible assets
−Removed: Warrants issued to lenders as debt inducement
−Removed: See accompanying notes to these consolidated financial
−Removed: INMUNE BIO INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: NOTE 1 – ORGANIZATION AND BASIS
−Removed: OF PRESENTATION
−Removed: Organization and Business Overview
+Added: accompanying notes to these consolidated financial statements.
+Added: TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: 1 – ORGANIZATION AND BASIS OF PRESENTATION
+Added: and Business Overview
INmune Bio Inc.
7 unchanged sentences
many diseases.
−Removed: DN-TNF is currently being developed for Alzheimer’s and treatment resistant depression (“XPro”) and cancer (“INB03”)
−Removed: and an out-licensing strategy for Duchenne’s Muscular Dystrophy (“DMD”).
−Removed: The Natural Killer Cell Priming Platform includes
−Removed: INKmune aimed at priming the patient’s NK cells to eliminate minimal residual disease in patients with cancer.
−Removed: product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic malignancies, solid tumors
−Removed: and chronic inflammation.
−Removed: Basis of Presentation and Principles of
−Removed: Consolidation
−Removed: The accompanying consolidated financial statements
−Removed: of the Company have been prepared in accordance with Generally Accepted Accounting Principles (“US GAAP”) in the United States
−Removed: of America and the rules of the Securities and Exchange Commission (“SEC”).
−Removed: The consolidated financial statements herein have
−Removed: been prepared in accordance with US GAAP and include the accounts of INmune Bio, its wholly-owned UK subsidiary, and its wholly-owned
−Removed: Australia subsidiary (collectively, the “Company”).
−Removed: All significant intercompany accounts and transactions have been eliminated.
−Removed: NOTE 2 – LIQUIDITY
−Removed: As of December
−Removed: 31, 2022, the Company had an accumulated deficit of $ 91,014,000 and experienced losses since its inception.
−Removed: The Company had cash,
−Removed: cash equivalents of $ 52,153,000 as of December 31, 2022 and has not generated positive cash flows from operations.
−Removed: To date, the Company
−Removed: has funded its operations primarily through the sale of its common stock.
−Removed: Although it is difficult to predict the Company’s liquidity
−Removed: requirements, as of December 31, 2022, and based upon the Company’s current operating plan, the Company believes that it will have
−Removed: sufficient cash to meet its projected operating requirements for at least the next 12 months following the filing date of this Annual
−Removed: Report on Form 10-K based on the balance of cash available as of December 31, 2022.
−Removed: expects operating losses to continue for the foreseeable future.
−Removed: There can be no assurance that the Company will ever earn revenues or
−Removed: achieve profitability, or if achieved, that they will be sustained on a continuing basis.
−Removed: In addition, the manufacturing, clinical and
−Removed: preclinical development activities as well as the commercialization of the Company’s products, if approved, will require significant
−Removed: additional financing.
−Removed: The Company may be unable to secure such financing when needed, or if available, such financings may be under terms
−Removed: that are unfavorable to the Company or the current stockholders.
−Removed: If the Company is unable to raise additional funds when needed, it may
−Removed: be required to delay, reduce the scope of, or eliminate development programs, which may adversely affect its business and operations.
−Removed: NOTE 3 – SUMMARY OF SIGNIFICANT
−Removed: ACCOUNTING POLICIES
−Removed: Use of Estimates
−Removed: Preparing financial statements in conformity with
−Removed: US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses.
+Added: DN-TNF is currently being developed for Alzheimer’s and treatment resistant depression (“XPro”) and cancer
+Added: (“INB03”) and an out-licensing strategy.
+Added: The Natural Killer Cell Priming Platform includes INKmune aimed at priming the patient’s
+Added: NK cells to eliminate minimal residual disease in patients with cancer.
+Added: INmune Bio’s product platforms utilize a precision medicine
+Added: approach for the treatment of a wide variety of hematologic malignancies, solid tumors and chronic inflammation.
+Added: of Presentation and Principles of Consolidation
+Added: accompanying consolidated financial statements of the Company have been prepared in accordance with Generally Accepted Accounting Principles
+Added: (“US GAAP”) in the United States of America and the rules of the Securities and Exchange Commission (“SEC”).
+Added: consolidated financial statements herein have been prepared in accordance with US GAAP and include the accounts of INmune Bio, its wholly-owned
+Added: UK subsidiary, and its wholly-owned Australia subsidiary (collectively, the “Company”).
+Added: All significant intercompany accounts
+Added: and transactions have been eliminated.
+Added: 2 – GOING CONCERN
+Added: These consolidated financial statements have been
+Added: prepared in accordance with generally accepted accounting principles applicable to a going concern, which contemplates the realization
+Added: of assets and the satisfaction of liabilities in the normal course of business.
+Added: The Company has incurred significant losses and negative cash flows from operations since inception and expects to incur additional losses
+Added: until such time that it can generate significant revenue from the commercialization of its product candidates.
+Added: The Company had net losses
+Added: of approximately $ 30.0 million and $ 27.3 million and negative cash flows from operating activities of approximately $ 12.0 million and
+Added: $ 22.7 million for the years ended December 31, 2023 and 2022, respectively, and an accumulated deficit of approximately $ 121.0 million
+Added: and $ 91.0 million as of December 31, 2023 and 2022, respectively.
+Added: Given the Company’s projected operating requirements and its existing
+Added: cash and cash equivalents, the Company is projecting insufficient liquidity to sustain its operations through one year following the date
+Added: that the financial statements are issued.
+Added: These conditions and events raise substantial doubt about the Company’s ability to continue
+Added: as a going concern.
+Added: In response to these conditions, management is
+Added: currently evaluating different strategies to obtain the required funding of future operations.
+Added: Financing strategies may include, but are
+Added: not limited to, the public or private sale of equity, debt financings or funds from other capital sources, such as government funding,
+Added: collaborations, strategic alliances, divestment of non-core assets, or licensing arrangements with third parties.
+Added: There can be no assurances
+Added: that the Company will be able to secure additional financing, or if available, that it will be sufficient to meet its needs or on favorable
+Added: Because management’s plans have not yet been finalized and are not within the Company’s control, the implementation
+Added: of such plans cannot be considered probable.
+Added: As a result, the Company has concluded that management’s plans do not alleviate substantial
+Added: doubt about the Company’s ability to continue as a going concern.
+Added: The consolidated financial statements do not include
+Added: any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities
+Added: that might result from the outcome of this uncertainty.
+Added: 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
+Added: financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts
+Added: of assets, liabilities, revenue, and expenses.
Actual results and outcomes may differ from management’s estimates and assumptions.
−Removed: Risks and Uncertainties
−Removed: The Company is subject to risks and uncertainties
−Removed: as a result of the COVID-19 pandemic.
−Removed: The extent of the impact of the COVID-19 pandemic on the Company’s business is highly uncertain
−Removed: and difficult to predict.
−Removed: Also, economies worldwide have also been negatively impacted by the COVID-19 pandemic, however policymakers
−Removed: around the globe have responded with fiscal policy actions to support the healthcare industry and economy as a whole.
−Removed: The magnitude and
−Removed: overall effectiveness of these actions remain uncertain.
−Removed: In addition, the Company’s clinical trials
−Removed: have been affected by and may continue to be affected by the COVID-19 pandemic.
−Removed: Clinical site initiation and patient enrollment have and
−Removed: may continue to be delayed due to prioritization of hospital resources toward the COVID-19 pandemic.
−Removed: Some patients have not, and others
−Removed: may not be able to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services.
−Removed: the ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened
−Removed: exposure to COVID-19, may adversely impact the Company’s clinical trial operations.
−Removed: The severity of the impact of the COVID-19 pandemic
−Removed: on the Company’s business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic
−Removed: and the extent and severity of the impact on the Company’s service providers, suppliers, contract research organizations (“CROs”)
−Removed: and the Company’s clinical trials, all of which are uncertain and cannot be predicted.
−Removed: As of the date of issuance of Company’s
−Removed: financial statements, the extent to which the COVID-19 pandemic may materially impact the Company’s financial condition, liquidity
−Removed: or results of operations is uncertain.
−Removed: Cash and Cash Equivalents
−Removed: The Company considers all highly liquid instruments purchased with
−Removed: an original maturity of three months or less to be cash equivalents.
−Removed: The Company holds cash in banks in excess of Federal Deposit Insurance
−Removed: Corporation insurance limits.
−Removed: However, the Company believes risk of loss is minimal as the cash is held by large, highly-rated financial
−Removed: institutions.
−Removed: Research and Development Tax Incentive Receivable
−Removed: The Company, through its wholly-owned subsidiary
−Removed: in Australia, participates in the Australian research and development tax incentive program, such that a percentage of our qualifying
−Removed: research and development expenditures are reimbursed by the Australian government, and such incentives are reflected as a reduction of
−Removed: research and development expense.
−Removed: The Australian research and development tax incentive is recognized when there is reasonable assurance
−Removed: that the incentive will be received, the relevant expenditure has been incurred and the amount of the consideration can be reliably measured.
−Removed: At each period end, management estimates the reimbursement available to the Company based on available information at the time.
−Removed: The Company, through its wholly-owned subsidiary
−Removed: in the United Kingdom, participates in the research and development program provided by the United Kingdom tax relief program, such that
−Removed: a percentage of our qualifying research and development expenditures are reimbursed by the United Kingdom government, and such incentives
−Removed: are reflected as a reduction of research and development expense.
−Removed: The United Kingdom research and development tax incentive is recognized
−Removed: when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the amount of the
−Removed: consideration can be reliably measured.
−Removed: At each period end, management estimates the reimbursement available to the Company based on available
−Removed: information at the time.
−Removed: Intangible Assets
−Removed: The Company capitalizes costs incurred in connection
−Removed: with in-process research and development purchased from others if the asset has alternative uses and such uses are not restricted under
−Removed: applicable license agreements;
−Removed: patent applications (principally legal fees), patent purchases, and trademarks related to its cell line
−Removed: as intangible assets.
−Removed: Acquired in-process research and development costs that do not have alternative uses are expensed as incurred.
−Removed: the assets are determined to have a finite life (upon completion of the development of the in-process research and development for its
−Removed: DN-TNF platform), the useful life will be determined, and the in-process research and development intangible assets will be amortized.
−Removed: During the fourth quarter and if business factors indicate more frequently,
−Removed: the Company performs an assessment of the qualitative factors affecting the fair value of our in-process research and development.
−Removed: the qualitative assessment suggests that impairment is more likely than not, a quantitative analysis is performed.
−Removed: The quantitative analysis
−Removed: involves a comparison of the fair value of the in-process research and development with the carrying amount.
−Removed: If the carrying amount of
−Removed: the in-process research and development exceeds its fair value, an impairment loss is recognized in an amount equal to that excess.
−Removed: the years ended December 31, 2022 and 2021, the Company performed a qualitative assessment of its in-process research and development
−Removed: and determined that there were no indicators of impairment.
−Removed: Basic and Diluted Loss per Share
−Removed: Basic loss per share is computed by dividing net
−Removed: loss available to common shareholders by the weighted average number of outstanding common shares during the period.
−Removed: Diluted loss per
−Removed: share gives effect to all dilutive potential common shares outstanding during the period.
−Removed: Dilutive loss per share excludes all potential
−Removed: common shares if their effect is anti-dilutive.
−Removed: For all periods presented, there is no difference in the number of shares used to calculate
−Removed: basic and diluted shares outstanding due to the Company’s net loss position.
−Removed: At December 31, 2022, the Company had 4,841,417
−Removed: potentially issuable shares of common stock upon the exercise of stock options and 74,074 potentially issuable shares of common stock
−Removed: upon the exercise of warrants.
−Removed: At December 31, 2021, the Company had 4,097,000
−Removed: potentially issuable shares of common stock upon the exercise of stock options and 93,866 potentially issuable shares of common stock
−Removed: upon the exercise of warrants.
−Removed: Revenue Recognition
−Removed: The Company recognizes revenue when the customer
−Removed: obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange
−Removed: for those goods or services.
−Removed: The Company recognizes revenue following the five-step model prescribed under ASC Topic 606:
−Removed: contract(s) with a customer;
+Added: Fair Value of Financial Instruments
+Added: The Company measures certain assets and liabilities
+Added: in accordance with authoritative guidance which requires fair value measurements to be classified and disclosed in one of the following
+Added: three categories:
+Added: Quoted prices (unadjusted)
+Added: in active markets that are accessible at the measurement date for assets or liabilities.
+Added: Observable prices that
+Added: are based on inputs not quoted on active markets but corroborated by market data.
+Added: Unobservable inputs are
+Added: used when little or no market data is available.
+Added: Assets and liabilities are classified based on
+Added: the lowest level of input that is significant to the fair value measurements.
+Added: The Company reviews the fair value hierarchy classification
+Added: on a quarterly basis.
+Added: Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets
+Added: or liabilities within the fair value hierarchy.
+Added: The Company did not have any transfers of assets and liabilities between the levels of
+Added: the fair value measurement hierarchy during the years presented.
+Added: The carrying amounts of financial instruments
+Added: such as cash and cash equivalents, research and development tax credit receivable, other receivable, prepaid expenses, and accounts payable
+Added: and accrued liabilities approximate the related fair values due to the short-term maturities of these instruments.
+Added: and Uncertainties
+Added: Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited
+Added: to, development by competitors of new technological innovations, protection of proprietary technology, dependence on key personnel, compliance
+Added: with government regulations and the need to obtain additional financing to fund operations.
+Added: Product candidates currently under development
+Added: will require significant additional research and development efforts, including extensive preclinical studies, clinical trials and regulatory
+Added: approval prior to commercialization.
+Added: These efforts require significant amounts of additional resources, adequate personnel, infrastructure
+Added: and extensive compliance and reporting.
+Added: Company’s product candidates are still in development and, to date, none of the Company’s product candidates have been approved
+Added: can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the
+Added: Company’s intellectual property will be obtained or maintained, that any products developed will obtain necessary government regulatory
+Added: approval or that any approved products will be commercially viable.
+Added: Even if the Company’s product development efforts are successful,
+Added: it is uncertain when, if ever, the Company will generate any revenue from any of its products.
+Added: The Company operates in an environment
+Added: of rapid change in technology and substantial competition from other pharmaceutical and biotechnology companies.
+Added: Company relies and expects to continue to rely on a small number of vendors to manufacture supplies and materials for its use in the
+Added: clinical trial programs.
+Added: These programs could be adversely affected by a significant interruption in these manufacturing services.
+Added: and Cash Equivalents
+Added: Company considers all highly liquid instruments purchased with an original maturity of three months or less to be cash equivalents.
+Added: Company holds cash in banks in excess of Federal Deposit Insurance Corporation insurance limits.
+Added: However, the Company believes risk of
+Added: loss is minimal as the cash is held by large, highly-rated financial institutions.
+Added: and Development Tax Incentive Receivable
+Added: Company, through its wholly-owned subsidiary in Australia, participates in the Australian research and development tax incentive program,
+Added: such that a percentage of our qualifying research and development expenditures are reimbursed by the Australian government, and such
+Added: incentives are reflected as a reduction of research and development expense.
+Added: The Australian research and development tax incentive is
+Added: recognized when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the
+Added: amount of the consideration can be reliably measured.
+Added: At each period end, management estimates the reimbursement available to the Company
+Added: based on available information at the time.
+Added: Company, through its wholly-owned subsidiary in the United Kingdom, participates in the research and development program provided by
+Added: the United Kingdom tax relief program, such that a percentage of our qualifying research and development expenditures are reimbursed
+Added: by the United Kingdom government, and such incentives are reflected as a reduction of research and development expense.
+Added: The United Kingdom
+Added: research and development tax incentive is recognized when there is reasonable assurance that the incentive will be received, the relevant
+Added: expenditure has been incurred and the amount of the consideration can be reliably measured.
+Added: At each period end, management estimates
+Added: the reimbursement available to the Company based on available information at the time.
+Added: Company capitalizes costs incurred in connection with in-process research and development purchased from others if the asset has alternative
+Added: uses and such uses are not restricted under applicable license agreements;
+Added: patent applications (principally legal fees), patent purchases,
+Added: and trademarks related to its cell line as intangible assets.
+Added: Acquired in-process research and development costs that do not have alternative
+Added: uses are expensed as incurred.
+Added: When the assets are determined to have a finite life (upon completion of the development of the in-process
+Added: research and development for its DN-TNF platform), the useful life will be determined, and the in-process research and development intangible
+Added: assets will be amortized.
+Added: the fourth quarter and if business factors indicate more frequently, the Company performs an assessment of the qualitative factors affecting
+Added: the fair value of our in-process research and development.
+Added: If the qualitative assessment suggests that impairment is more likely than
+Added: not, a quantitative analysis is performed.
+Added: The quantitative analysis involves a comparison of the fair value of the in-process research
+Added: and development with the carrying amount.
+Added: If the carrying amount of the in-process research and development exceeds its fair value, an
+Added: impairment loss is recognized in an amount equal to that excess.
+Added: During the years ended December 31, 2023 and 2022, the Company performed
+Added: a qualitative assessment of its in-process research and development and determined that there were no indicators of impairment.
+Added: and Diluted Loss per Share
+Added: loss per share is computed by dividing net loss available to common shareholders by the weighted average number of outstanding common
+Added: shares during the period.
+Added: Diluted loss per share gives effect to all dilutive potential common shares outstanding during the period.
+Added: Dilutive loss per share excludes all potential common shares if their effect is anti-dilutive.
+Added: For all periods presented, there is no
+Added: difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position.
+Added: December 31, 2023, the Company had 5,496,000 potentially issuable shares of common stock upon the exercise of stock options and 45,386
+Added: potentially issuable shares of common stock upon the exercise of warrants.
+Added: December 31, 2022, the Company had 4,841,417 potentially issuable shares of common stock upon the exercise of stock options and 74,074
+Added: potentially issuable shares of common stock upon the exercise of warrants.
+Added: Company recognizes revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration
+Added: the Company expects to receive in exchange for those goods or services.
+Added: The Company recognizes revenue following the five-step model
+Added: prescribed under ASC Topic 606:
+Added: (1) identify contract(s) with a customer;
(2) identify the performance obligations in the contract;
determine the transaction price;
−Removed: the transaction price to the performance obligations in the contract;
−Removed: and (5) recognize revenues when (or as) the Company satisfies the
−Removed: performance obligations.
−Removed: The Company records the expenses related to revenue in research and development expense, in the periods such
−Removed: expenses were incurred.
−Removed: The Company records deferred revenues when cash
−Removed: payments are received or due in advance of performance, including amounts which are refundable.
−Removed: The Company’s 2022 and 2021 revenue was
−Removed: from the sale of MSC’s to one and three customers, respectively, and was recognized when the MSC’s were delivered to the customers.
−Removed: Stock-Based Compensation
−Removed: The Company utilizes the Black-Scholes option
−Removed: pricing model to estimate the fair value of stock option awards at the date of grant, which requires the input of highly subjective assumptions,
−Removed: including expected volatility and expected life.
−Removed: Changes in these inputs and assumptions can materially affect the measure of estimated
−Removed: fair value of our share-based compensation.
−Removed: These assumptions are subjective and generally require significant analysis and judgment to
−Removed: When estimating fair value, some of the assumptions will be based on, or determined from, external data and other assumptions
−Removed: may be derived from our historical experience with stock-based payment arrangements.
−Removed: The appropriate weight to place on historical experience
−Removed: is a matter of judgment, based on relevant facts and circumstances.
−Removed: The Company accounts for forfeitures of stock options as they occur.
−Removed: Research and Development
−Removed: Research and development (“R&D”)
−Removed: costs are expensed as incurred.
−Removed: Research and development credits are recorded by the Company as a reduction of research and development
−Removed: Major components of research and development costs include cash compensation, stock-based compensation, costs of preclinical studies,
−Removed: clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead
−Removed: costs, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development
−Removed: activities on the Company’s behalf.
−Removed: The Company recognizes grants as contra research
−Removed: and development expense in the consolidated statement of operations on a systematic basis over the periods in which the entity recognizes
−Removed: as expenses the related costs for which the grants are intended to compensate.
−Removed: The Company follows the liability method of accounting
−Removed: for income taxes.
−Removed: Under this method, deferred income tax assets and liabilities are recognized for the estimated tax consequences attributable
−Removed: to differences between the financial statement carrying values and their respective income tax basis (temporary differences).
−Removed: on deferred income tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment
−Removed: Foreign Currency Translation
−Removed: The Company’s financial statements are presented
−Removed: dollar (“$”), which is the Company’s reporting currency, while its functional currencies are the U.S.
−Removed: based operations, British Pound (“GBP”) for its United Kingdom-based operations and Australian Dollars (“AUD”)
−Removed: for its Australian-based operations.
−Removed: All assets and liabilities are translated at the exchange rate on the balance sheet date, stockholders’
−Removed: equity is translated at historical rates and statement of operations items are translated at the weighted average exchange rate for the
−Removed: The resulting translation adjustments are reported under other comprehensive income.
−Removed: Gains and losses resulting from the translations
−Removed: of foreign currency transactions and balances are reflected in the statement of operations and comprehensive loss.
−Removed: Recently Adopted Accounting Pronouncements
−Removed: In June 2016, the FASB issued ASU No.
−Removed: 2016-13, Financial
−Removed: Instruments—Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments, as clarified in subsequent amendments.
−Removed: ASU 2016-13 changes the impairment model for certain financial instruments.
−Removed: The new model is a forward-looking expected loss model and
−Removed: will apply to financial assets subject to credit losses and measured at amortized cost and certain off-balance sheet credit exposures.
−Removed: This includes loans, held-to-maturity debt securities, loan commitments, financial guarantees and net investments in leases, as well as
−Removed: trade receivables.
−Removed: For available-for-sale debt securities with unrealized losses, credit losses will be measured in a manner similar to
−Removed: today, except that the losses will be recognized as allowances rather than reductions in the amortized cost of the securities.
−Removed: 2019, the FASB voted to delay the effective date of this standard.
−Removed: Topic 326 will be effective for the Company on January 1, 2023.
−Removed: Company does not expect this standard to have a material effect on the Company’s financial statements.
−Removed: Subsequent Events
−Removed: The Company has evaluated all transactions through
−Removed: the financial statement issuance date for subsequent disclosure consideration.
−Removed: NOTE 4 – RESEARCH AND DEVELOPMENT
−Removed: According to UK tax law, the Company is allowed
−Removed: 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.
−Removed: The Company’s UK subsidiary submits R&D tax credit requests annually for research and development expenses incurred.
−Removed: 31, 2022 and 2021, the Company had a research and development tax credit receivable of $ 2,690,000 and $ 3,319,000 , respectively for
−Removed: R&D expenses incurred in the UK.
−Removed: During the years ended December 31, 2022 and 2021, the Company received $ 0 and $ 814,000 of R&D
−Removed: tax credit reimbursements, respectively from the UK.
−Removed: During January 2023, the Company received $ 2,710,000 of R&D tax credit reimbursements
−Removed: According to AUS tax law, the Company is allowed an R&D tax
−Removed: credit that reduces a company’s tax bill in AUS for expenses incurred in R&D subject to certain requirements.
−Removed: The Company’s
−Removed: Australian subsidiary submits R&D tax credit requests annually for research and development expenses incurred.
−Removed: At December 31, 2022
−Removed: and 2021, the Company had a research and development tax credit receivable of $ 5,409,000 and $ 1,594,000 , respectively, for R&D
−Removed: expenses incurred in Australia.
−Removed: During the years ended December 31, 2022 and 2021, the Company received $ 0 and $ 1,296,000 of R&D tax
−Removed: credit reimbursements, respectively from Australia.
−Removed: During February 2023, the Company received $ 3,763,000 of R&D tax credit reimbursements
−Removed: from Australia.
+Added: (4) allocate the transaction price to the performance obligations in the contract;
+Added: and (5) recognize
+Added: revenues when (or as) the Company satisfies the performance obligations.
+Added: The Company records the expenses related to revenue in research
+Added: and development expense, in the periods such expenses were incurred.
+Added: Company records deferred revenues when cash payments are received or due in advance of performance, including amounts which are refundable.
+Added: Company’s 2023 and 2022 revenue was from the sale of MSC’s to one customer and was recognized when the MSC’s were delivered
+Added: to the customers.
+Added: Company utilizes the Black-Scholes option pricing model to estimate the fair value of stock option awards at the date of grant, which
+Added: requires the input of highly subjective assumptions, including expected volatility and expected life.
+Added: Changes in these inputs and assumptions
+Added: can materially affect the measure of estimated fair value of our share-based compensation.
+Added: These assumptions are subjective and generally
+Added: require significant analysis and judgment to develop.
+Added: When estimating fair value, some of the assumptions will be based on, or determined
+Added: from, external data and other assumptions may be derived from our historical experience with stock-based payment arrangements.
+Added: The appropriate
+Added: weight to place on historical experience is a matter of judgment, based on relevant facts and circumstances.
+Added: The Company accounts for
+Added: forfeitures of stock options as they occur.
+Added: and Development
+Added: and development (“R&D”) costs are expensed as incurred.
+Added: Research and development credits are recorded by the Company
+Added: as a reduction of research and development costs.
+Added: Major components of research and development costs include cash compensation, stock-based
+Added: compensation, clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities
+Added: cost, overhead costs, costs of pre-clinical trials, regulatory and compliance costs, and fees paid to consultants and other entities
+Added: that conduct certain research and development activities on the Company’s behalf.
+Added: Company recognizes grants as contra research and development expense in the consolidated statement of operations on a systematic basis
+Added: over the periods in which the entity recognizes as expenses the related costs for which the grants are intended to compensate.
+Added: Company follows the liability method of accounting for income taxes.
+Added: Under this method, deferred income tax assets and liabilities are
+Added: recognized for the estimated tax consequences attributable to differences between the financial statement carrying values and their respective
+Added: income tax basis (temporary differences).
+Added: The effect on deferred income tax assets and liabilities of a change in tax rates is recognized
+Added: in income in the period that includes the enactment date.
+Added: Currency Translation
+Added: Company’s financial statements are presented in the U.S.
+Added: dollar (“$”), which is the Company’s reporting currency,
+Added: while its functional currencies are the U.S.
+Added: Dollar for its U.S.
+Added: based operations, British Pound (“GBP”) for its United Kingdom-based
+Added: operations and Australian Dollars (“AUD”) for its Australian-based operations.
+Added: All assets and liabilities are translated
+Added: at the exchange rate on the balance sheet date, stockholders’ equity is translated at historical rates and statement of operations
+Added: items are translated at the weighted average exchange rate for the period.
+Added: The resulting translation adjustments are reported under other
+Added: comprehensive income.
+Added: Gains and losses resulting from the translations of foreign currency transactions and balances are reflected in
+Added: the statement of operations and comprehensive loss.
+Added: Accounting Pronouncements
+Added: December 2023, the FASB issued ASU No.
+Added: 2023-09, Income Taxes (Topic 740):
+Added: Improvements to Income Tax Disclosures (“ASU
+Added: The guidance in ASU 2023-09 improves the transparency of income tax disclosures by greater disaggregation of information
+Added: in the rate reconciliation and income taxes paid disaggregated by jurisdiction.
+Added: The standard is effective for public companies for fiscal
+Added: years beginning after December 15, 2024, with early adoption permitted.
+Added: The Company is currently evaluating the impact that the adoption
+Added: of ASU 2023-09 may have on its consolidated financial statements.
+Added: Company has evaluated all transactions through the financial statement issuance date for subsequent disclosure consideration.
+Added: 4 – RESEARCH AND DEVELOPMENT ACTIVITY
+Added: to UK tax law, the Company is allowed an R&D tax credit that reduces a company’s tax bill in the UK for expenses incurred in
+Added: R&D subject to certain requirements.
+Added: The Company’s UK subsidiary submits R&D tax credit requests annually for research
+Added: and development expenses incurred.
+Added: At December 31, 2023 and 2022, the Company had a research and development tax credit receivable of
+Added: $ 0 and $ 2,690,000 , respectively for R&D expenses incurred in the UK.
+Added: During the years ended December 31, 2023 and 2022, the Company
+Added: received $ 2,710,000 and $ 0 of R&D tax credit reimbursements, respectively from the UK.
+Added: According to AUS tax law, the Company is allowed an R&D tax credit
+Added: that reduces a company’s tax bill in AUS for expenses incurred in R&D subject to certain requirements.
+Added: The Company’s Australian
+Added: subsidiary submits R&D tax credit requests annually for research and development expenses incurred.
+Added: At December 31, 2023 and 2022,
+Added: the Company had a research and development tax credit receivable of $ 1,905,000 and $ 5,409,000 , respectively, for R&D expenses incurred
+Added: in Australia.
+Added: During the years ended December 31, 2023 and 2022, the Company received $ 6,557,000 and $ 0 of R&D tax credit reimbursements,
+Added: respectively from Australia.
License Agreement
−Removed: On October 3, 2017, the Company entered into a license agreement (“Xencor
−Removed: License Agreement”) with Xencor, Inc.
−Removed: (“Xencor”), which has discovered and developed a proprietary biological molecule
−Removed: that inhibits soluble tumor necrosis factor.
−Removed: During June 2021, the Company entered into the First Amendment to License Agreement.
−Removed: to 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 product
−Removed: that comprises, contains, or incorporates Xencor’s proprietary protein known as “XPro” that inhibits soluble tumor necrosis
−Removed: factor (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: believes the protein has numerous medical applications.
−Removed: Such additional alternative applications of the technology are available under
−Removed: the Xencor License Agreement.
−Removed: In connection with the Xencor 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 common stock
−Removed: equal to 10 % of the fully diluted company shares immediately following such purchase, which warrant has since been cancelled (see the
−Removed: description below).
−Removed: The aggregate purchase price for the full exercise of the warrant was $ 10,000,000 .
−Removed: The Company recorded $ 16,514,000 for the acquisition
−Removed: 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
−Removed: License Agreement acquisition in accordance with Accounting Standards Codification 730 – Research and Development .
−Removed: has the license rights to pursue alternative applications of the technology as part of its future development plans.
−Removed: The Company also agreed to pay Xencor a 5 % royalty on Net Sales of
−Removed: all Licensed Products in a given calendar year, which are payable on a country-by- country and licensed product by licensed product basis
−Removed: until the date that is the later of (a) the expiration of the last to expire valid claim covering such Licensed Product in such country
−Removed: or (b) ten years following the first sale to a third party of the licensed product in such country.
−Removed: Under the Xencor License Agreement, the Company
−Removed: also agreed to pay Xencor a percentage of any sublicensing revenue that it receives.
−Removed: On June 10, 2021, the Company and Xencor entered
−Removed: into an Option Cancellation Agreement whereby Xencor terminated its warrant to purchase 10 % of the fully diluted shares of the Company
−Removed: 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
−Removed: on the market price of the common stock as of June 10, 2021, which the Company issued in June 2021.
−Removed: The Company filed a registration statement
−Removed: covering the resale of these shares during September 2021 and agreed to keep the registration statement continuously effective until all
−Removed: such shares cease to be outstanding or otherwise cease to be registrable securities as defined in the Option Cancellation Agreement.
−Removed: Company charged the cash consideration paid to Xencor to enter into the Option Cancellation Agreement to equity as the fair value of the
−Removed: warrant immediately prior to the Option Cancellation Agreement was greater than the consideration paid to Xencor.
−Removed: INKmune License Agreement
−Removed: On October 29, 2015, the Company entered into
−Removed: an exclusive license agreement (the “INKmune License Agreement”) with Immune Ventures, LLC (“Immune Ventures”).
−Removed: Pursuant to the INKmune License Agreement, the Company was granted exclusive worldwide rights to the patents, including rights to incorporate
−Removed: any improvements or additions to the patents that may be developed in the future.
−Removed: In consideration for the patent rights, the Company
−Removed: agreed to the following milestone payments:
+Added: October 3, 2017, the Company entered into a license agreement (“Xencor License Agreement”) with Xencor, Inc.
+Added: which discovered and developed a proprietary biological molecule that inhibits soluble tumor necrosis factor.
+Added: On June 10, 2021, the Company
+Added: and Xencor entered into a First Amendment to License Agreement pursuant to which, among other things, Section 3.2 of the Xencor License
+Added: Agreement was amended to change the due diligence milestones.
+Added: Pursuant to the Xencor License Agreement, Xencor granted the Company an
+Added: exclusive worldwide, royalty-bearing license in licensed patent rights, licensed know-how and licensed materials (as defined in the license
+Added: agreement) to make, develop, use, sell and import any pharmaceutical product that comprises, contains, or incorporates Xencor’s
+Added: proprietary protein known as “XPro” that inhibits soluble tumor necrosis factor (or all modifications, formulations and variants
+Added: of the licensed protein that specifically bind soluble tumor necrosis factor) alone or in combination with one or more active ingredients,
+Added: in any dosage or formulation (“Licensed Products”).
+Added: The Company believes the protein has numerous medical applications.
+Added: additional alternative applications of the technology are available under the Xencor License Agreement.
+Added: Company also agreed to pay Xencor a 5 %
+Added: royalty on Net Sales of all Licensed Products in a given calendar year, which are payable on a country-by- country and licensed product
+Added: by licensed product basis until the date that is the later of (a) the expiration of the last to expire valid claim covering such Licensed
+Added: Product in such country or (b) ten years following the first sale to a third party of the licensed product in such country.
+Added: License Agreement
+Added: October 29, 2015, the Company entered into an exclusive license agreement (the “INKmune License Agreement”) with Immune Ventures,
+Added: LLC (“Immune Ventures”).
+Added: Pursuant to the INKmune License Agreement, the Company was granted exclusive worldwide rights to
+Added: the patents, including rights to incorporate any improvements or additions to the patents that may be developed in the future.
+Added: In consideration
+Added: for the patent rights, the Company agreed to the following milestone payments:
(in thousands)
4 unchanged sentences
Each NDA/EMA awarded
−Removed: During July 2021, the Company initiated a Phase
−Removed: I clinical trial using INKmune and the Company paid Immune Ventures a $ 25,000 milestone payment.
−Removed: In addition, the Company agreed to pay the licensor
−Removed: a royalty of 1 % of net sales during the life of each patent granted to the Company.
+Added: addition, the Company agreed to pay the licensor a royalty of 1 % of net sales during the life of each patent granted to the Company.
The License is owned by Immune Ventures.
−Removed: the Company’s President and a member of our Board of Directors, David Moss, its Chief Financial Officer and Treasurer and Mark Lowdell,
−Removed: its Chief Scientific Officer, are the owners of Immune Ventures.
−Removed: As of December 31, 2022 and December 31, 2021, no sales had occurred
−Removed: under this license.
−Removed: The term of the agreement began on October 29,
−Removed: 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
−Removed: last to expire patent rights where patent rights exists.
−Removed: Upon the termination of the agreement, we shall have a fully paid up, perpetual,
−Removed: royalty-free license without further obligation to Immune Ventures.
−Removed: The agreement can be terminated by Immune Ventures if, after 60 days
−Removed: from the Company’s receipt of notice that the Company has not made a payment under the agreement, and the Company still does not
−Removed: make this payment.
−Removed: On July 20, 2018, the parties amended the agreement under which the Company was required achieve milestones pursuant
−Removed: to the agreement.
−Removed: On October 30, 2020, the parties executed an additional amendment to the agreement under which the Company is required
−Removed: to achieve the following milestones:
−Removed: Initiation of Phase II clinical trials or equivalent
−Removed: by October 29, 2023
−Removed: Initiation of Phase III clinical trials or equivalent
−Removed: by October 29, 2025
−Removed: Filing of NDA or equivalent by October 29, 2026
−Removed: or equivalent
−Removed: If the Company doesn’t achieve the above
−Removed: milestones, it is required to negotiate in good faith with Immune Ventures to determine how it can either remedy the failure or achieve
−Removed: an alternate development.
−Removed: If the Company fails to make any required efforts, or if the efforts do not remedy the situation within 60 days
−Removed: of written notice by Immune Ventures, then Immune Ventures may provide notice to terminate the license or convert it to a non-exclusive
−Removed: University of Pittsburg License Agreement
−Removed: On October 3, 2017, the Company entered into an
−Removed: Assignment and Assumption Agreement with Immune Ventures related to intellectual property licensed from the University of Pittsburgh.
−Removed: Pursuant to the Assignment and Assumption Agreement (“Assignment Agreement”), Immune Ventures assigned all of its rights,
−Removed: obligations and liabilities under an Exclusive License Agreement between the University of Pittsburgh – Of the Commonwealth System
−Removed: of Higher Education (“Licensor”) and Immune Ventures to INmune Bio (“Licensee”), (the “PITT Agreement”).
−Removed: Consideration under the PITT Agreement includes:
−Removed: (i) annual maintenance fees, (ii) royalty payments based on the sale of products making use of the licensed technology, and (iii) milestone
−Removed: Annual maintenance fees under the PITT Agreement
−Removed: $ 5,000 due June 26 of each year 2020-2022;
+Added: RJ Tesi, the Company’s President and a member of our Board of Directors, David Moss, its
+Added: Chief Financial Officer and Treasurer and Mark Lowdell, its Chief Scientific Officer, are the owners of Immune Ventures.
+Added: No sales have
+Added: occurred under this license.
+Added: During December 2023, the Company initiated a Phase I trial with INKmune in patients with metastatic castration-resistant
+Added: prostate cancer and has recorded a $ 25,000 payable to Immune Ventures as of December 31, 2023.
+Added: term of the agreement began on October 29, 2015 and ends on a country-by-country basis on the date of the expiration of the last to expire
+Added: patent rights where patent rights exists, unless terminated earlier in accordance with the agreement.
+Added: Upon the termination of the agreement,
+Added: we shall have a fully paid up, perpetual, royalty-free license without further obligation to Immune Ventures.
+Added: The agreement can be terminated
+Added: by Immune Ventures if, after 60 days from the Company’s receipt of notice that the Company has not made a payment under the agreement,
+Added: and the Company still does not make this payment.
+Added: On July 20, 2018 and October 30, 2020, the parties amended the agreement under
+Added: which the Company was required achieve milestones pursuant to the agreement.
+Added: April 17, 2023, the parties executed an additional amendment to the agreement under which the Company removed the due diligence requirements
+Added: to achieve reasonable commercial efforts to bring INKmune to market.
+Added: This removed all requirements of clinical trial timelines and the
+Added: filing timelines of an NDA or equivalent.
+Added: All other provisions in the INKmune License Agreement shall continue in full force and effect.
+Added: of Pittsburg License Agreement
+Added: October 3, 2017, the Company entered into an Assignment and Assumption Agreement with Immune Ventures related to intellectual property
+Added: licensed from the University of Pittsburgh.
+Added: Pursuant to the Assignment and Assumption Agreement (“Assignment Agreement”),
+Added: Immune Ventures assigned all of its rights, obligations and liabilities under an Exclusive License Agreement between the University of
+Added: Pittsburgh – Of the Commonwealth System of Higher Education (“Licensor”) and Immune Ventures to INmune Bio (“Licensee”),
+Added: (the “PITT Agreement”).
+Added: Consideration
+Added: under the PITT Agreement includes:
+Added: (i) annual maintenance fees, (ii) royalty payments based on the sale of products making use of the
+Added: licensed technology, and (iii) milestone payments.
+Added: maintenance fees under the PITT Agreement include:
$ 10,000 due on June 26 of each year 2023-2024;
2 unchanged sentences
The Company had no amounts owed pursuant to the PITT Agreement as of December
−Removed: (in thousands)
−Removed: June 26 of each year 2020-2022
−Removed: June 26 of each year 2023-2024
−Removed: June 26 of each year 2025 until first commercial sale
−Removed: Upon first commercial sale of a product making
−Removed: 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
−Removed: There were no commercial sales of product making use of the licensed technology under the PITT Agreement in 2022.
−Removed: Moreover, under the PITT Agreement the Licensee
−Removed: is required to make milestone payments as follows:
+Added: first commercial sale of a product making use of the licensed technology under the PITT Agreement, the Licensee is required to pay royalties
+Added: equal to 2.5 % of Net Sales each calendar quarter.
+Added: As of December 31, 2023, there have been no commercial sales of product making use
+Added: of the licensed technology under the PITT Agreement.
+Added: under the PITT Agreement the Licensee is required to make milestone payments as follows:
(in thousands)
2 unchanged sentences
First commercial sale of product making use of licensed technology
−Removed: The Company made a $ 50,000 milestone payment in
−Removed: March 2019 pursuant to the PITT Agreement as a result of a Phase I initiation.
−Removed: The PITT Agreement expires upon the earlier of:
−Removed: (i) expiration
−Removed: of the last claim of the Patent Rights forming the subject matter of the PITT Agreement;
−Removed: or (ii) the date that is 20 years from the effective
−Removed: date of the agreement (June 26, 2037).
−Removed: The Licensee may terminate the PITT Agreement
−Removed: upon 3 months prior written notice provided all payments under the license are current.
−Removed: The Licensor may terminate the PITT Agreement
−Removed: upon written notice if:
−Removed: (i) Licensee defaults as to performance of material obligations which have not been cured within 60 days after
−Removed: receiving written notice;
−Removed: or (ii) Licensee ceases to carry out its business, becomes bankrupt or insolvent, applies for or consents to
−Removed: the appointment of a trustee, receiver or liquidator of its assets or seeks relief under any law for the aid of debtors.
−Removed: NOTE 5 – FAIR VALUE MEASUREMENTS
−Removed: The following table presents the hierarchy
−Removed: for assets and liabilities measured at fair value on a recurring basis:
+Added: PITT Agreement expires upon the earlier of:
+Added: (i) expiration of the last claim of the Patent Rights forming the subject matter of the PITT
+Added: or (ii) the date that is 20 years from the effective date of the agreement (June 26, 2037).
+Added: Licensee may terminate the PITT Agreement upon 3 months prior written notice provided all payments under the license are current.
+Added: Licensor may terminate the PITT Agreement upon written notice if:
+Added: (i) Licensee defaults as to performance of material obligations which
+Added: have not been cured within 60 days after receiving written notice;
+Added: or (ii) Licensee ceases to carry out its business, becomes bankrupt
+Added: or insolvent, applies for or consents to the appointment of a trustee, receiver or liquidator of its assets or seeks relief under any
+Added: law for the aid of debtors.
+Added: 5 – FAIR VALUE MEASUREMENTS
+Added: following table presents the hierarchy for assets and liabilities measured at fair value on a recurring basis:
(in thousands)
5 unchanged sentences
Total cash equivalents
−Removed: The Company had no assets and liabilities measured
−Removed: at fair value on a recurring basis as of December 31, 2021.
−Removed: NOTE 6 – LEASE
−Removed: In May 2019, the Company signed a sublease agreement
−Removed: with CTI Clinical Trial & Consulting Services (“CTI”) for office space in La Jolla, California.
−Removed: The lessor was CTI Clinical
−Removed: Trial & Consulting Services (“CTI”).
−Removed: CTI is majority-owned by a member of the Company’s Board of Directors.
−Removed: 2022, the Company entered into a sublease termination agreement with CTI whereby the Company paid CTI $ 153,000 to terminate the sublease.
−Removed: During the year ended December 31, 2022, the Company recorded a right-of-use asset impairment of $ 89,000 within general and administrative
−Removed: In September 2021, the Company signed a lease with a third party for
−Removed: office space in Boca Raton, Florida.
−Removed: The lease agreement has a 64 -month term and commenced during the fourth quarter of 2021.
−Removed: Below is a summary of the Company’s right-of-use
−Removed: assets and liabilities:
+Added: (in thousands)
+Added: Active Market
+Added: Observable Inputs
+Added: December 31, 2022:
+Added: Cash equivalents
+Added: Money market fund
+Added: Total cash equivalents
+Added: September 2021, the Company signed a lease 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: is a summary of the Company’s right-of-use assets and liabilities:
(in thousands, except years and rate)
−Removed: Right-of-use asset (La Jolla lease)
−Removed: Right-of-use asset (Boca Raton lease)
−Removed: Operating lease, current liability (La Jolla lease)
−Removed: Operating lease, current liability (Boca Raton lease)
−Removed: Long-term operating lease liability (La Jolla lease)
−Removed: Long-term operating lease liability (Boca Raton lease)
+Added: Right-of-use asset
+Added: Operating lease, current liability
+Added: Long-term operating lease liability
Total lease liability
1 unchanged sentence
Weighted-average discount rate
−Removed: NOTE 7 – RELATED PARTY TRANSACTIONS
−Removed: At December 31, 2022 and 2021, the Company owed
−Removed: UCL Consultants Limited (“UCL”) $ 0 and $ 10,000 , respectively, in connection with medical research performed on behalf of the
−Removed: During the years ended December 31, 2022 and 2021, the Company paid UCL $ 586,000 and $ 218,000 , respectively, for medical research
−Removed: performed on behalf of the Company.
−Removed: UCL is a wholly owned subsidiary of the University of London.
−Removed: The Company’s Chief Scientific
−Removed: and Manufacturing Officer is a professor at the University of London.
−Removed: years ended December 31, 2022 and 2021, the Company paid CTI $ 153,000 and $ 38,000 , respectively, pursuant to its sublease agreement with
−Removed: The Company also paid CTI $ 5,000 in 2022 for medical research performed on behalf of the Company.
−Removed: During the years ended December
−Removed: 31, 2022 and 2021, the Company paid AmplifyBio $ 230,000 and $ 0 , respectively, to perform certain medical research on behalf of the Company.
+Added: 7 – RELATED PARTY TRANSACTIONS
+Added: During the years ended December 31, 2023 and 2022,
+Added: the Company paid UCL $ 573,000 and $ 586,000 , respectively, for medical research performed on behalf of the Company.
+Added: UCL is a wholly owned
+Added: subsidiary of the University of London.
+Added: The Company’s Chief Scientific and Manufacturing Officer is a professor at the University
+Added: 2022, the Company paid CTI $ 153,000 pursuant to its former sublease agreement with CTI and $ 5,000 for research and development performed
+Added: on behalf of the Company.
+Added: The Company had no transactions with CTI in 2023.
+Added: the years ended December 31, 2023 and 2022, the Company paid AmplifyBio $ 77,000 and $ 230,000 , respectively, to perform certain research
+Added: and development on behalf of the Company.
The CEO of AmplifyBio is on the Board of Directors of the Company.
−Removed: 10, 2021, the Company entered into a Loan and Security Agreement (the “Term Loan”) with Silicon Valley Bank and SVB Innovation
−Removed: Credit Fund VIII, L.P., together (the “Lenders”).
−Removed: The Term Loan provides for a $ 15.0 million term loan, of which
−Removed: the Company borrowed the entire amount on June 10, 2021 and is secured by the Company’s assets.
−Removed: The Term Loan also provides
−Removed: 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
−Removed: of the Lenders.
−Removed: loan and debt discount are as follows as of December 31, 2022:
+Added: June 10, 2021, the Company entered into a Loan and Security Agreement (the “Term Loan”) with Silicon Valley Bank and SVB
+Added: Innovation Credit Fund VIII, L.P., together (the “Lenders”).
+Added: The Term Loan provides for a $ 15.0 million term loan,
+Added: of which the Company borrowed the entire amount on June 10, 2021 and is secured by the Company’s assets.
+Added: The Term Loan also
+Added: provides for the Company to request an additional $ 5.0 million term loan from the Lenders, which may be granted or denied at the
+Added: sole discretion of the Lenders.
+Added: term loan and debt discount are as follows as of December 31, 2023:
(in thousands)
−Removed: debt discount and financing costs, net
Current portion
−Removed: Long-term debt
−Removed: years ended December 31, 2022 and 2021, the Company recognized interest expense of $ 2,014,000 and $ 985,000 , respectively, related to the
−Removed: loan repayment schedule provided for interest only payments beginning on July 1, 2021, and continuing for 12 months, followed by monthly
−Removed: principal and interest payments, starting on July 1, 2022 and continuing through the maturity date of January 1, 2025.
−Removed: During August
−Removed: 2021, the Lenders extended the interest-only period for one year due to the Company achieving an equity milestone as fully defined
−Removed: in the Term Loan.
−Removed: As a result of achieving the equity milestone, monthly principal and interest payments begin on July 1, 2023.
−Removed: All outstanding
−Removed: principal and accrued and unpaid interest will be due and payable on the maturity date.
−Removed: The Term Loan provides for an annual interest
−Removed: 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: debt discount
+Added: Current portion of debt,
+Added: the years ended December 31, 2023 and 2022, the Company recognized interest expense of $ 2,278,000 and $ 2,014,000 , respectively, related
+Added: to the Term Loan.
+Added: Term Loan provides for an annual interest rate equal to the greater of (i) the prime rate then in effect as reported in The Wall Street
+Added: Journal plus 4.50 % and (ii) 7.75 %.
At December 31, 2023, the interest rate was 13.0 %.
−Removed: Loan includes a final payment fee equal to 6.5 % of the original principal amount borrowed payable on the earlier of the repayment
+Added: Term Loan includes a final payment fee equal to 6.5 % of the original principal amount borrowed payable on the earlier of the repayment
of the loan in full and the maturity date.
−Removed: The Company has the option to prepay the outstanding balance of the term loans in full,
−Removed: subject to a prepayment premium of (i) 2 % of the original principal amount borrowed for any prepayment after the first anniversary and
−Removed: on or before the second anniversary of the loan or (ii) 1 % of the original principal amount borrowed for any prepayment after the
−Removed: second anniversary of the loan but before the maturity date.
−Removed: repayment of the $ 15.0 million Term loan principal is as follows as of December 31, 2022:
−Removed: (in thousands,
−Removed: except years)
−Removed: occurrence of certain events, including but not limited to the Company’s failure to satisfy its payment obligations under the Term
−Removed: Loan, the breach of certain of its other covenants under the Term Loan, or the occurrence of a material adverse change, the Lenders will
−Removed: have the right, among other remedies, to declare all principal and interest immediately due and payable, and will have the right to receive
−Removed: the final payment fee and, if the payment of principal and interest is due prior to maturity, the applicable prepayment fee.
−Removed: violated certain non-financial debt covenants as of December 31, 2022 and received a waiver from the Lenders waiving these debt covenant
−Removed: NOTE 9 – STOCKHOLDERS’ EQUITY
+Added: The Company has the option to prepay the outstanding balance of the term loan in full, subject
+Added: to a prepayment premium of 1 % of the original principal amount borrowed for any prepayment before the maturity date.
+Added: the occurrence of certain events, including but not limited to the Company’s failure to satisfy its payment obligations under the
+Added: Term Loan, the breach of certain of its other covenants under the Term Loan, or the occurrence of a material adverse change, the Lenders
+Added: will have the right, among other remedies, to declare all principal and interest immediately due and payable, and will have the right
+Added: to receive the final payment fee and, if the payment of principal and interest is due prior to maturity, the applicable prepayment fee.
+Added: 9 – STOCKHOLDERS’ EQUITY
+Added: Stock – At the Market Offering
+Added: March 2021, the Company entered into a sales agreement (“Sales Agreement”) with BTIG, LLC (“BTIG”), as sales
+Added: agent, to establish an At-The-Market (“ATM”) offering program of up to $ 45 million of common stock, subject to certain
+Added: limitations on the amount of common stock that may be offered and sold by the Company set forth in the sales agreement.
+Added: During August
+Added: 2023, the Company and BTIG entered into Amendment No.
+Added: 1 to the Sales Agreement.
+Added: The Company is required to pay BTIG a commission of 3 %
+Added: of the gross proceeds from the sale of shares.
+Added: July 2023, the Company sold 75,697 shares of its common stock at an average price of $ 10.56 per share under the ATM program.
+Added: The aggregate net proceeds were approximately $ 775,000 after offering expenses.
+Added: These shares were inadvertently sold under a registration
+Added: statement filed with the SEC that had in fact expired prior to the time the shares were sold.
+Added: Consequently, the Company may
+Added: be subject to claims for rescission by purchasers who purchased shares of common stock under the ATM program.
+Added: Under Section
+Added: 12(a)(1) of the Securities Act, a purchaser of security in a transaction made in violation of Section 5 of the Securities Act may obtain
+Added: recovery of the consideration paid in connection with its purchase, plus statutory interest, or, if it had already sold the shares, recover
+Added: damages resulting from its purchase.
+Added: While the Company believes, it is unlikely that a successful claim will be asserted against the
+Added: Company by any purchasers who purchased shares of common stock under the ATM Agreement in July 2023, the Company cannot guarantee that
+Added: no such legal claims will be asserted against the Company by any purchasers.
+Added: In addition, the Company could become subject to enforcement
+Added: actions and/or penalties and fines by federal authorities, and the Company is unable to predict the likelihood of any such enforcement
+Added: actions being brought, or the amount of any such potential penalties or fines.
+Added: As of December 31, 2023, there have been no claims or
+Added: demands to exercise such rights.
+Added: As a result of these potential rescission rights, the Company reclassified 75,697 shares,
+Added: with an aggregate purchase price of $ 799,000 of its common stock as temporary equity presented outside stockholders’ equity.
+Added: The reclassification of these shares shall remain for a period of one year from transaction date.
+Added: These shares have been treated as issued
+Added: and outstanding for financial reporting purposes.
+Added: December 31, 2023, the Company has $ 28.7 million of common stock available under the ATM program.
Stock – Issuance to Directors and Officers
−Removed: year ended December 31, 2022, directors and officers of the Company purchased 82,900 shares of the Company’s common stock
−Removed: from the Company at $ 8.43 per share (which was the closing price of the Company’s common stock on March 22, 2022) for
+Added: the year ended December 31, 2022, directors and officers of the Company purchased 82,900 shares of the Company’s common
+Added: stock from the Company at $ 8.43 per share (which was the closing price of the Company’s common stock on March 22, 2022) for
gross proceeds of $ 699,000 .
−Removed: Common Stock – At the Market Offerings
−Removed: April 2020, the Company entered into a sales agreement with BTIG, LLC (“BTIG"), as sales agent, to establish an ATM
−Removed: offering to sell up to $ 10.0 million of the Company’s common stock (the “2020 ATM”).
−Removed: In August 2020, the
−Removed: sales agreement was amended whereby the aggregate offering was increased from $ 10.0 million to $ 30.0 million.
−Removed: the year ended December 31, 2021, the Company sold 1,439,480 shares of its common stock at an average price of $20.17 per share
−Removed: under the 2020 ATM agreement.
−Removed: The aggregate net proceeds were approximately $28.4 million after BTIG’s commission and other
−Removed: offering expenses.
−Removed: During March 2021, the Company entered into a sales agreement with
−Removed: BTIG, as agent, to establish an At-The-Market (“ATM”) offering of up to $ 45 million of common stock (the “2021
−Removed: ATM”), subject to certain limitations on the amount of common stock that may be offered and sold by the Company set forth in the
−Removed: sales agreement.
−Removed: During the year ended December 31, 2021, the Company
−Removed: sold 713,192 shares of its common stock at an average price of $21.73 per share under the 2021 ATM agreement.
−Removed: The aggregate net proceeds
−Removed: were approximately $14.9 million after BTIG’s commission and other offering expenses.
−Removed: Direct Offering
−Removed: 2021, the Company completed a registered direct offering whereby the Company sold 1,818,182 shares of its common stock to investors
−Removed: for gross proceeds of $ 38.0 million (net proceeds of $ 36.9 million).
−Removed: of shares to Xencor
−Removed: 10, 2021, the Company and Xencor entered into an Option Cancellation Agreement whereby the Company issued 192,533 shares of
−Removed: its common stock to Xencor (See Note 4).
−Removed: Stock options
+Added: June 1, 2023, the Company’s shareholders approved an amendment to the 2021 Incentive Stock Plan (“2021 Amended and Restated
+Added: Incentive Stock Plan”) to increase the shares of the Company’s common stock available for issuance thereunder to 4,000,000 shares.
+Added: 2023, the Company granted certain employees and directors options to purchase 665,000 shares of its common stock pursuant to
+Added: the 2017 and 2019 Incentive Stock Plans and 2021 Amended and Restated Incentive Stock Plan.
+Added: The stock options had a fair value of approximately
+Added: $ 4.9 million that was calculated using the Black-Scholes option-pricing model.
+Added: Variables used in the Black-Scholes option-pricing
+Added: model include:
+Added: (1) discount rate of 3.84 % – 3.99 % based on the applicable US Treasury bill rate (2) expected life of 6.0 – 6.25 years,
+Added: (3) expected volatility of approximately 91 % based on the trading history of similar companies, and (4) zero expected dividends.
the Company granted certain employees and directors options to purchase 819,000 shares of its common stock pursuant to the 2021
6 unchanged sentences
- 108 % based on the trading history of similar companies, and (4) zero expected dividends.
−Removed: During 2021, the Company granted various employees,
−Removed: consultants and directors options to purchase 823,000 shares of common stock pursuant to the 2021, 2019 and 2017 Incentive Stock Plans.
−Removed: 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
−Removed: Variables used in the Black-Scholes option-pricing model include:
−Removed: (1) discount rate of 0.78 - 1.49 %% based on the applicable US Treasury
−Removed: 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
−Removed: companies, and (4) zero expected dividends.
−Removed: At December 31, 2022, the Company had 607,108 shares reserved for issuance,
−Removed: of which 591,132 shares were available for issuance pursuant to the 2021 Incentive Stock Plan, 7,313 shares were available for issuance
−Removed: pursuant to the 2019 Incentive Stock Plan, and 8,663 shares were available for issuance pursuant to the 2017 Stock Incentive Plan.
−Removed: The following table summarizes stock option activity:
+Added: December 31, 2023, the Company had 1,952,525 shares reserved for issuance pursuant to the 2021 Amended and Restated Incentive Stock Plan.
+Added: following table summarizes stock option activity:
(in thousands, except share and per share amounts)
−Removed: Outstanding at January 1, 2021
+Added: Outstanding at December 31, 2021
Options granted
3 unchanged sentences
Options granted
−Removed: Options exercised
Options cancelled
1 unchanged sentence
Exercisable at December 31, 2023
−Removed: During the years ended December 31, 2022 and 2021,
−Removed: the Company recognized stock-based compensation expense of $ 7,149,000 and $ 4,796,000 , respectively, related to stock options.
−Removed: As of December
−Removed: 31, 2021, there was $ 11,198,000 of total unrecognized compensation cost related to non-vested stock options which is expected to be recognized
−Removed: over a weighted-average period of 2.23 years.
+Added: the years ended December 31, 2023 and 2022, the Company recognized stock-based compensation expense of $ 7,368,000 and $ 7,149,000 , respectively,
+Added: related to stock options.
+Added: As of December 31, 2023, there was $ 8,592,000 of total unrecognized compensation cost related to non-vested
+Added: stock options which is expected to be recognized over a weighted-average period of 2.05 years.
The Company issued warrants to the Company’s
1 unchanged sentence
The warrants have a 10 -year term and an exercise price of $ 14.05 .
−Removed: At December 31, 2022, 45,386 of
−Removed: these warrants are outstanding and the intrinsic value of these warrants is $ 0 .
−Removed: The Company issued warrants to its placement agents
−Removed: in connection with its February 2019 initial public offering.
−Removed: The warrants are exercisable until December 19, 2023 and have an exercise
−Removed: price of $ 9.60 .
−Removed: At December 31, 2022, 28,688 of these warrants are outstanding and the intrinsic value is $ 0 .
−Removed: During the year ended December 31, 2022, a third
−Removed: party exercised 19,792 warrants which were issued in 2017 for cash proceeds of approximately $ 30,000 .
−Removed: The Company issued 19,792 shares of its common stock in connection with the exercise of warrants.
−Removed: Stock-based Compensation by Class of Expense
−Removed: The following summarizes the components of stock-based
−Removed: compensation expense in the consolidated statements of operations for the years ended December 31, 2022 and 2021 respectively:
+Added: At December 31, 2023
+Added: and 2022, respectively, 45,386 of these warrants are outstanding and the intrinsic value of these warrants is $ 0 .
+Added: the year ended December 31, 2023, a third party exercised 28,688 warrants on a cashless basis in exchange for 4,781 shares of common
+Added: the year ended December 31, 2022, a third party exercised 19,792 warrants in exchange for 19,792 shares of common stock for
+Added: cash proceeds of approximately $ 30,000 .
+Added: Compensation by Class of Expense
+Added: The following summarizes the components of stock-based compensation
+Added: expense in the consolidated statements of operations for the years ended December 31, 2023 and 2022, respectively:
Research and development
General and administrative
−Removed: Shareholder Rights Agreement
−Removed: On December 30, 2020, the Board of Directors (the
−Removed: “Board”) of the Company approved and adopted a Rights Agreement, dated as of December 30, 2020, by and between the Company
−Removed: and VStock Transfer, LLC, as rights agent, pursuant to which the Board declared a dividend of one preferred share purchase right (each,
−Removed: a “Right”) for each outstanding share of the Company’s common stock held by stockholders as of the close of business
−Removed: on January 11, 2021.
−Removed: When exercisable, each right initially would represent the right to purchase from the Company one one-thousandth
−Removed: of a share of a newly designated series of preferred stock, Series A Junior Participating Preferred Stock, par value $0.001 per share,
−Removed: of the Company, at an exercise price of $300.00 per one one-thousandth of a Series A Junior Participating Preferred Share, subject to
−Removed: Subject to various exceptions, the Rights become exercisable in the event any person (excluding certain exempted or grandfathered
−Removed: persons) becomes the beneficial owner of twenty percent or more of the Company’s common stock without the approval of the Board.
−Removed: The Rights Agreement shall expire on December 30, 2023.
−Removed: Preferred Stock
+Added: Rights Agreement
+Added: December 30, 2020, the Board of Directors (the “Board”) of the Company approved and adopted a Rights Agreement, dated as
+Added: of December 30, 2020, by and between the Company and VStock Transfer, LLC, as rights agent, pursuant to which the Board declared a dividend
+Added: of one preferred share purchase right (each, a “Right”) for each outstanding share of the Company’s common stock held
+Added: by stockholders as of the close of business on January 11, 2021.
+Added: When exercisable, each right initially would represent the right to
+Added: purchase from the Company one one-thousandth of a share of a newly designated series of preferred stock, Series A Junior Participating
+Added: Preferred Stock, par value $ 0.001 per share, of the Company, at an exercise price of $ 300.00 per one one-thousandth of a Series A Junior
+Added: Participating Preferred Share, subject to adjustment.
+Added: Subject to various exceptions, the Rights become exercisable in the event any person
+Added: (excluding certain exempted or grandfathered persons) becomes the beneficial owner of twenty percent or more of the Company’s
+Added: common stock without the approval of the Board.
+Added: The Rights Agreement was amended in 2021, 2022 and 2023 to extend the expiration date
+Added: and shall expire on December 30, 2024.
In 2020, the Company designated 45,000 shares
4 unchanged sentences
2023 and 2022.
−Removed: NOTE 10 – INCOME
−Removed: The provision for income taxes consists of the
−Removed: following components:
+Added: 10 – INCOME TAXES
+Added: provision for income taxes consists of the following components :
Current expense (benefit)
3 unchanged sentences
Net deferred taxes
−Removed: A reconciliation of income tax benefit computed
−Removed: using the federal statutory income tax rate to the Company’s tax expense is as follows:
+Added: reconciliation of income tax benefit computed using the federal statutory income tax rate to the Company’s tax expense is as follows:
(in thousands, except percentage)
7 unchanged sentences
Income tax benefit
−Removed: The principal components of deferred tax assets
−Removed: and liabilities consist of the following at December 31, 2022 and 2021, respectively:
+Added: principal components of deferred tax assets and liabilities consist of the following at December 31, 2023 and 2022, respectively:
(in thousands)
8 unchanged sentences
Net deferred tax assets
−Removed: At December 31, 2022, the Company had a federal net
−Removed: operating loss carryforward of approximately $ 25.9 million.
−Removed: The net operating loss carryforwards for 2017 will begin to expire in the
−Removed: year ending December 31, 2037.
+Added: At December 31, 2023, the Company had a federal
+Added: net operating loss carryforward of approximately $ 32.6 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: The Company’s gross deferred tax assets of $ 13.7 million and $ 6.8
−Removed: million at December 31, 2022 and 2021, respectively, primarily consist of net operating loss carryforwards for income tax purposes.
−Removed: valuation allowance is required to be recorded when it is not more likely than not that some portion or all of the net deferred tax assets
−Removed: will be realized.
−Removed: Since the Company cannot be assured of generating taxable income and thereby realizing the net deferred tax assets,
−Removed: a full valuation allowance has been recorded.
−Removed: The change in the valuation allowance was $ 6,943,000 during the year ended December
−Removed: The Company recognizes uncertain tax positions
−Removed: 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
−Removed: examination by tax authorities.
−Removed: For those tax positions that meet the more-likely-than not recognition threshold, we recognize the largest
−Removed: amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement.
−Removed: As of December 31, 2022, and 2021,
−Removed: the Company has no significant uncertain tax positions.
−Removed: There are no unrecognized tax benefits included on the balance sheet that would,
−Removed: if recognized, impact the effective tax rate.
−Removed: The Company does not anticipate there will be a significant change in unrecognized tax benefits
−Removed: within the next 12 months.
−Removed: NOTE 11 – COLLABORATIVE AGREEMENTS
−Removed: During 2020, the Company was awarded a $ 500,000
−Removed: grant from the Amyotrophic Lateral Sclerosis (“ALS”) Association to fund a study of the efficacy of XPro to reverse ALS in
−Removed: vitro and to fund a study of the efficacy of XPro to protect against ALS model phenotypes in vivo.
−Removed: All of the proceeds pursuant to the
−Removed: grant were received prior to 2022.
−Removed: The grant period for the study ended December 31, 2022 and the Company has recorded a payable of $ 18,000
−Removed: to the ALS Association in accounts payable and accrued liabilities for amounts received but not spent as of December 31, 2022.
−Removed: During September 2020, the Company was awarded a grant of up to $2.9
−Removed: million from the National Institutes of Health (“NIH”).
−Removed: The grant will support a Phase 2 study of XPro in patients with treatment
−Removed: resistant depression.
−Removed: As of December 31, 2022, the Company has not received any proceeds pursuant to this grant.
+Added: Company’s gross deferred tax assets of $ 19.6 million and $ 13.7 million at December 31, 2023 and 2022, respectively, primarily consist
+Added: of net operating loss carryforwards for income tax purposes.
+Added: A valuation allowance is required to be recorded when it is not more likely
+Added: than not that some portion or all of the net deferred tax assets will be realized.
+Added: Since the Company cannot be assured of generating
+Added: taxable income and thereby realizing the net deferred tax assets, a full valuation allowance has been recorded.
+Added: The change in the
+Added: valuation allowance was $ 5,872,000 during the year ended December 31, 2023.
+Added: Company recognizes uncertain tax positions in accordance with ASC 740 on the basis of evaluating whether it is more likely than not that
+Added: the tax positions will be sustained upon examination by tax authorities.
+Added: For those tax positions that meet the more-likely-than not recognition
+Added: threshold, we recognize the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement.
+Added: As of December 31, 2023, and 2022, the Company has no significant uncertain tax positions.
+Added: There are no unrecognized tax benefits included
+Added: on the balance sheet that would, if recognized, impact the effective tax rate.
+Added: The Company does not anticipate there will be a significant
+Added: change in unrecognized tax benefits within the next 12 months.
+Added: 11 – COLLABORATIVE AGREEMENTS
+Added: September 2020, the Company was awarded a grant of up to $ 2.9 million from the National Institutes of Health (“NIH”).
+Added: grant will support a Phase 2 study of XPro in patients with treatment resistant depression.
+Added: As of December 31, 2023, the Company has
+Added: not received any proceeds pursuant to this grant.
12 – COMMITMENTS AND CONTINGENCIES
−Removed: During September 2021, the Company
−Removed: signed a lease agreement with a third party for office space in Boca Raton, Florida.
−Removed: The operating lease has a 64-month term and
−Removed: commenced during the fourth quarter of 2021.
−Removed: Future minimum payments pursuant
−Removed: to the leases are as follows:
−Removed: (in thousands,
−Removed: except years)
+Added: September 2021, the Company signed a lease agreement with a third party for office space in Boca Raton, Florida.
+Added: The operating lease
+Added: has a 64-month term and commenced during the fourth quarter of 2021.
+Added: minimum payments pursuant to the leases are as follows:
+Added: (in thousands, except years)
Total lease payments
3 unchanged sentences
Long-term operating lease liabilities
−Removed: During the years ended December 31, 2022 and 2021,
−Removed: the Company recognized $ 209,000 and $ 102,000 , respectively, in operating lease expense, which is included in general and administrative
−Removed: expenses in the Company’s consolidated statement of operations.
−Removed: is subject to claims and suits that arise from time to time in the ordinary course of our business.
−Removed: Although management currently believes
−Removed: that resolving claims against the Company, individually or in aggregate, will not have a material adverse impact in the Company’s
+Added: the years ended December 31, 2023 and 2022, the Company recognized $ 163,000 and $ 209,000 , respectively, in operating lease expense, which
+Added: is included in general and administrative expenses in the Company’s consolidated statement of operations.
+Added: Company is subject to claims and suits that arise from time to time in the ordinary course of our business.
+Added: Although management currently
+Added: believes that resolving claims against the Company, individually or in aggregate, will not have a material adverse impact in the Company’s
consolidated financial statements, these matters are subject to inherent uncertainties and management’s view of these matters may
change in the future.
−Removed: 13 – SUBSEQUENT EVENTS
−Removed: During February
−Removed: 2023, the Company issued 605,000 stock options with a 10 -year life and an exercise price of $ 9.74 to certain employees and directors.
−Removed: The stock options had a fair value of approximately $ 4.5 million that was calculated using the Black-Scholes option-pricing model.
−Removed: Changes in and Disagreements with Accountants
−Removed: on Accounting and Financial Disclosure
+Added: Changes in and Disagreements with Accountants 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.