CONTROLS AND PROCEDURES
−Removed: Evaluation of Disclosure Controls and
−Removed: We have established disclosure
−Removed: controls and procedures, as such term is defined in Rule 13a-15(e) under the Securities Exchange Act of 1934.
−Removed: supervision and with the participation of our management, we conducted an evaluation of the effectiveness of our disclosure
−Removed: controls and procedures as of December 31, 2019 to ensure that the information required to be disclosed by us in the reports
−Removed: that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized, and reported within the
−Removed: time periods specified in the SEC’s rules and forms.
−Removed: Disclosure controls and procedures include, without limitation,
−Removed: controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or
−Removed: submit under the Securities Exchange Act of 1934 is accumulated and communicated to our management, including our principal
−Removed: executive officer and principal financial officer as appropriate, to allow timely decisions regarding required disclosure.
−Removed: Our management, with participation of our principal executive officer and principal financial officer, has evaluated the
−Removed: effectiveness of our disclosure controls and procedures as of December 31, 2019.
−Removed: Based on that evaluation, our principal
−Removed: executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of
−Removed: December 31, 2019 to provide reasonable assurance that the information required to be disclosed
−Removed: by us in this Annual Report was (a) reported within the time periods specified by SEC rules and regulations and (b)
−Removed: communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions
−Removed: regarding any required disclosure.
−Removed: Management’s Report on Internal
−Removed: Control Over Financial Reporting and Report of Independent Registered Public Accounting Firm
−Removed: Our management is responsible for establishing
−Removed: and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f) and
−Removed: Under the supervision and with the participation of our management, including our principal executive, financial and
−Removed: accounting officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of December
−Removed: 31, 2019 based on the framework in Internal Control—Integrated Framework 2013 issued by the Committee of Sponsoring Organizations
−Removed: of the Treadway Commission (COSO).
−Removed: Based on that evaluation, our management concluded that our internal control over financial
−Removed: reporting was effective as of December 31, 2019.
−Removed: Our independent registered public accounting
−Removed: firm, Marcum LLP, has issued an attestation report on our internal control over financial reporting.
−Removed: The report on the audit of
−Removed: internal control over financial reporting is included in Part II, Item 8 of this Annual Report on Form 10-K.
+Added: Evaluation of Disclosure Controls and Procedures
+Added: We have established disclosure controls and procedures, as such term is defined in Rule 13a-15(e) under the Securities Exchange Act of 1934.
+Added: Under the supervision and with the participation of our management, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of December 31, 2020 to ensure that the information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms.
+Added: Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act of 1934 is accumulated and communicated to our management, including our principal executive officer and principal financial officer as appropriate, to allow timely decisions regarding required disclosure.
+Added: Our management, with participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2020.
+Added: Based on that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of December 31, 2020 to provide reasonable assurance that the information required to be disclosed by us in this Annual Report was (a) reported within the time periods specified by SEC rules and regulations and (b) communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding any required disclosure.
+Added: Management’s Report on Internal Control Over Financial Reporting
+Added: Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f).
+Added: Under the supervision and with the participation of our management, including our principal executive, financial and accounting officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2020 based on the framework in Internal Control—Integrated Framework 2013 issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
+Added: Based on that evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2020.
Cybersecurity
−Removed: We utilize information technology for internal
−Removed: and external communications with vendors, clinical sites, banks, investors and shareholders.
−Removed: Loss, disruption or compromise of
−Removed: these systems could significantly impact operations and results.
−Removed: We are not aware of any material cybersecurity
−Removed: violation or occurrence.
−Removed: We believe our efforts toward prevention of such violation or occurrence, including system design and
−Removed: controls, processes and procedures, training and monitoring of system access, limit, but may not prevent unauthorized access to
−Removed: Other than temporary disruption to operations
−Removed: that may be caused by a cybersecurity breach, we consider cash transactions to be the primary risk for potential loss.
−Removed: financial institution take steps to minimize the risk by requiring multiple levels of authorization and other controls.
−Removed: Changes in Internal Control Over Financial
−Removed: There were no changes in our internal
−Removed: control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) during the fiscal quarter ended December
−Removed: 31, 2019 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
−Removed: Inherent Limitations on Effectiveness
−Removed: of Internal Controls
−Removed: In designing and evaluating the
−Removed: disclosure controls and procedures, management does not expect that our internal control over financial reporting will
−Removed: prevent or detect all errors and all fraud.
−Removed: A control system, no matter how well conceived and operated, can provide only
−Removed: reasonable, not absolute, assurance that the objectives of the control systems are met.
−Removed: Further, the design of a control
−Removed: system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to
−Removed: The design of any disclosure controls and procedures also is based in part upon certain assumptions about the
−Removed: likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under
−Removed: all potential future conditions.
−Removed: Our management, including our Chief Executive Officer and Chief Financial Officer, believes
−Removed: that our disclosure controls and procedures and internal control over financial reporting are designed to provide reasonable
−Removed: assurance of achieving their objectives and are effective at the reasonable assurance level.
−Removed: However, our management does not
−Removed: expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors
−Removed: and all fraud.
+Added: We utilize information technology for internal and external communications with vendors, clinical sites, banks, investors and shareholders.
+Added: Loss, disruption or compromise of these systems could significantly impact operations and results.
+Added: We are not aware of any material cybersecurity violation or occurrence.
+Added: We believe our efforts toward prevention of such violation or occurrence, including system design and controls, processes and procedures, training and monitoring of system access, limit, but may not prevent unauthorized access to our systems.
+Added: Other than temporary disruption to operations that may be caused by a cybersecurity breach, we consider cash transactions to be the primary risk for potential loss.
+Added: We and our financial institution take steps to minimize the risk by requiring multiple levels of authorization and other controls.
+Added: Changes in Internal Control Over Financial Reporting
+Added: There were no changes in our internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) during the fiscal quarter ended December 31, 2020 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
+Added: Inherent Limitations on Effectiveness of Internal Controls
+Added: In designing and evaluating the disclosure controls and procedures, management does not expect that our internal control over financial reporting will prevent or detect all errors and all fraud.
+Added: A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control systems are met.
+Added: Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs.
+Added: The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
+Added: Our management, including our Chief Executive Officer and Chief Financial Officer, believes that our disclosure controls and procedures and internal control over financial reporting are designed to provide reasonable assurance of achieving their objectives and are effective at the reasonable assurance level.
+Added: However, our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud.
OTHER INFORMATION
−Removed: Award of 2019 Performance Bonuses and 2020 Equity Incentive
−Removed: On March 10, 2020, upon the recommendation of the compensation
−Removed: committee and pursuant to our 2014 Omnibus Stock Ownership Plan, our board of directors approved options to purchase our common
−Removed: stock as (i) performance bonuses for 2019 performance and (ii) equity-based incentive awards to our executive officers, as follows:
−Removed: Name and Title
−Removed: Number of Shares of Common Stock Underlying 2019 Performance Bonus Award
−Removed: Number of Shares of Common Stock Underlying 2020 Equity Incentive Award
−Removed: President and Chief Executive Officer
−Removed: Chief Financial Officer
−Removed: Chief Development Officer
−Removed: Mythili Koneru
−Removed: Chief Medical Officer
−Removed: Michael Loiacono
−Removed: Chief Accounting Officer
−Removed: Nadia Agopyan
−Removed: Vice President, Regulatory Affairs
−Removed: Gerald Garrett
−Removed: Vice President, Clinical Operations
−Removed: Vice President, Research & Development
−Removed: Anna Szymanska
−Removed: Vice President, Quality
−Removed: Each option award was granted with an exercise price of $2.12
−Removed: per share, the closing price of our common stock on the Nasdaq Global Market on March 10, 2020, with the option award vesting in
−Removed: 48 equal monthly installments over a four-year period, subject to such executive officer’s continued service on the applicable
−Removed: vesting date.
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
−Removed: The information required by this item and
−Removed: not set forth below will be set forth in the sections headed “Election of Directors,”
−Removed: “Management and Named Executive
−Removed: Officers”
−Removed: and “Section 16(a) Beneficial Ownership Reporting Compliance”
−Removed: in our definitive proxy statement for
−Removed: our 2019 Annual Meeting of Stockholders, or our Proxy Statement, to be filed with the SEC within 120 days after the end of the
−Removed: fiscal year ended December 31, 2019, and is incorporated herein by reference.
−Removed: We have adopted a written code of business
−Removed: conduct and ethics that applies to our directors, officers and employees, including our principal executive officer, principal
−Removed: financial and accounting officer or controller, or persons performing similar functions, known as the Code of Ethics and Business
−Removed: The Code of Ethics and Business Conduct is available on our website at www.markertherapeutics.com under the Corporate
−Removed: Governance section of our Investors page.
−Removed: If we make any substantive amendments to, or grant any waivers from, the code of business
−Removed: conduct and ethics for any officer or director, we will disclose the nature of such amendment or waiver on our website or in a
−Removed: current report on Form 8-K.
+Added: The information required by this item and not set forth below will be set forth in the sections headed “Election of Directors,” “Management and Named Executive Officers” and “Section 16(a) Beneficial Ownership Reporting Compliance” in our definitive proxy statement for our 2020 Annual Meeting of Stockholders, or our Proxy Statement, to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2020 and is incorporated herein by reference.
+Added: We have adopted a written code of business conduct and ethics that applies to our directors, officers and employees, including our principal executive officer, principal financial and accounting officer or controller, or persons performing similar functions, known as the Code of Ethics and Business Conduct.
+Added: The Code of Ethics and Business Conduct is available on our website at www.markertherapeutics.com under the Corporate Governance section of our Investors page.
+Added: If we make any substantive amendments to, or grant any waivers from, the code of business conduct and ethics for any officer or director, we will disclose the nature of such amendment or waiver on our website or in a current report on Form 8-K.
EXECUTIVE COMPENSATION
−Removed: The information required by this item will
−Removed: be set forth in the section headed “Executive Compensation-Compensation Discussion and Analysis”
−Removed: in our Proxy Statement
−Removed: and is incorporated herein by reference.
+Added: The information required by this item will be set forth in the section headed “Executive Compensation-Compensation Discussion and Analysis” in our Proxy Statement and is incorporated herein by reference.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
−Removed: The information required by this item will
−Removed: be set forth in the section headed “Equity Compensation Plan Information”
−Removed: and “Security Ownership of Management
−Removed: and Certain Beneficial Owners”
−Removed: in our Proxy Statement and is incorporated herein by reference.
−Removed: The information required by Item 201(d) of Regulation S-K will
−Removed: be set forth in the section headed “Executive Compensation-Compensation Discussion and Analysis”
−Removed: and “Board of
−Removed: Directors and Corporate Governance”
−Removed: in our Proxy Statement and is incorporated herein by reference.
+Added: The information required by this item will be set forth in the section headed “Equity Compensation Plan Information” and “Security Ownership of Management and Certain Beneficial Owners” in our Proxy Statement and is incorporated herein by reference.
+Added: The information required by Item 201(d) of Regulation S-K will be set forth in the section headed “Executive Compensation-Compensation Discussion and Analysis” and “Board of Directors and Corporate Governance” in our Proxy Statement and is incorporated herein by reference.
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
−Removed: The information required by this item will
−Removed: be set forth in the section headed “Certain Relationships and Related Transactions”
−Removed: and “Board of Directors and
−Removed: Corporate Governance”
−Removed: in our Proxy Statement and is incorporated herein by reference.
+Added: The information required by this item will be set forth in the section headed “Certain Relationships and Related Transactions” and “Board of Directors and Corporate Governance” in our Proxy Statement and is incorporated herein by reference.
PRINCIPAL ACCOUNTING FEES AND SERVICES
−Removed: The information required by this item will
−Removed: be set forth in the section headed “Independent Auditors’
−Removed: Fees and Services”
−Removed: in our Proxy Statement and is incorporated
−Removed: herein by reference.
+Added: The information required by this item will be set forth in the section headed “Independent Auditors’ Fees and Services” in our Proxy Statement and is incorporated herein by reference.
EXHIBITS, FINANCIAL STATEMENT SCHEDULES
−Removed: (a) The documents filed
−Removed: as part of this report are as follows:
−Removed: financial statements and accompanying report of independent registered public accounting firm are set forth immediately following
−Removed: the signature page of this report on pages F-1 through F-27.
−Removed: All financial statement
−Removed: schedules are omitted because they are inapplicable, not required or the information is included elsewhere in the financial statements
−Removed: or the notes thereto.
−Removed: The following
−Removed: is a list of exhibits filed as part of this Annual Report on Form 10-K.
+Added: (a) The documents filed as part of this report are as follows:
+Added: The financial statements and accompanying report of independent registered public accounting firm are set forth immediately following the signature page of this report on pages F-1 through F-21.
+Added: All financial statement schedules are omitted because they are inapplicable, not required or the information is included elsewhere in the financial statements or the notes thereto.
+Added: The following is a list of exhibits filed as part of this Annual Report on Form 10-K.
EXHIBIT INDEX
15 unchanged sentences
Form of Amended Series E Warrant
+Added: Incorporated by Reference
+Added: Exhibit description
Form of Amended Series A-1 Warrant
23 unchanged sentences
2009 Stock Incentive Plan*
+Added: Incorporated by Reference
+Added: Exhibit description
2014 Omnibus Stock Ownership Plan, as amended through August 29, 2017*
Amendment to 2014 Omnibus Stock Ownership Plan, as amended *
−Removed: Form of Stock Option Award Agreement –Employee*
−Removed: Form of Stock Option Award Agreement –
−Removed: Non-Employee Director*
−Removed: Form of Stock Option Award Agreement –
−Removed: Form of Restricted Stock Award Agreement –
+Added: Form of Stock Option Award Agreement –Employee*
+Added: Form of Stock Option Award Agreement – Non-Employee Director*
+Added: Form of Stock Option Award Agreement – Consultant*
+Added: Form of Restricted Stock Award Agreement – Consultant*
Employment Agreement between TapImmune Inc.
16 unchanged sentences
and Mythili Koneru, dated February 6, 2019.*
+Added: Marker Therapeutics, Inc.
+Added: 2020 Equity Incentive Plan
+Added: Incorporated by Reference
+Added: Exhibit description
+Added: Form of Stock Option Grant Notice and Stock Option Agreement under the Marker Therapeutics, Inc.
+Added: 2020 Equity Incentive Plan.
+Added: Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Award Agreement under the Marker Therapeutics, Inc.
+Added: 2020 Equity Incentive Plan.
List of Subsidiaries
13 unchanged sentences
XBRL Taxonomy Extension Presentation Linkbase Document
−Removed: management contract or compensatory plan or arrangement.
−Removed: ** Confidential
−Removed: treatment has been granted as to certain portions of this exhibit pursuant to Rule 406 of the Securities Act of 1933, as amended,
−Removed: or Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
−Removed: of this exhibit (indicated by asterisks) have been omitted pursuant to a request for conditional treatment and this exhibit has
−Removed: been submitted separately with the SEC.
+Added: * Executive management contract or compensatory plan or arrangement.
+Added: ** Confidential treatment has been granted as to certain portions of this exhibit pursuant to Rule 406 of the Securities Act of 1933, as amended, or Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
+Added: *** Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for conditional treatment and this exhibit has been submitted separately with the SEC.
+Added: # These certifications are being furnished solely to accompany this annual report pursuant to 18 U.S.C.
+Added: Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
FORM 10-K SUMMARY
−Removed: Pursuant to the requirements of Section 13 and 15 (d) of the
−Removed: Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
−Removed: duly authorized.
+Added: Pursuant to the requirements of Section 13 and 15 (d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
March 9, 2021
5 unchanged sentences
POWER OF ATTORNEY
−Removed: Each of the undersigned officers and directors
−Removed: of Marker Therapeutics, Inc., hereby constitutes and appoints Peter Hoang and Anthony Kim, their true and lawful attorney-in-fact
−Removed: and agent, for them and in their name, place and stead, in any and all capacities, to sign their name to any and all amendments
−Removed: to this Report on Form 10-K, and other related documents, and to cause the same to be filed with the Securities and Exchange Commission,
−Removed: granting unto said attorneys, full power and authority to do and perform any act and thing necessary and proper to be done in the
−Removed: premises, as fully to all intents and purposes as the undersigned could do if personally present, and the undersigned for himself
−Removed: hereby ratifies and confirms all that said attorney shall lawfully do or cause to be done by virtue hereof.
−Removed: Pursuant to the requirements of the Securities
−Removed: Exchange Act of 1934, this report has been signed below by the following persons on March 12, 2020 on behalf of the registrant
−Removed: and in the capacities indicated.
+Added: Each of the undersigned officers and directors of Marker Therapeutics, Inc., hereby constitutes and appoints Peter Hoang and Anthony Kim, their true and lawful attorney-in-fact and agent, for them and in their name, place and stead, in any and all capacities, to sign their name to any and all amendments to this Report on Form 10-K, and other related documents, and to cause the same to be filed with the Securities and Exchange Commission, granting unto said attorneys, full power and authority to do and perform any act and thing necessary and proper to be done in the premises, as fully to all intents and purposes as the undersigned could do if personally present, and the undersigned for himself hereby ratifies and confirms all that said attorney shall lawfully do or cause to be done by virtue hereof.
+Added: Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on March 9, 2021 on behalf of the registrant and in the capacities indicated.
/s/ Peter Hoang
17 unchanged sentences
March 9, 2021
−Removed: MARKER THERAPETUICS, INC.
+Added: MARKER THERAPEUTICS, INC.
CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2019
+Added: DECEMBER 31, 2020 AND DECEMBER 31, 2019
Report of Independent Registered Public Accounting Firm
1 unchanged sentence
Consolidated Statements of Operations
−Removed: Consolidated Statements of Stockholders’
−Removed: Equity (Deficit)
+Added: Consolidated Statements of Stockholders’ Equity
Consolidated Statements of Cash Flows
Notes to the Consolidated Financial Statements
−Removed: REPORT OF INDEPENDENT REGISTERED
−Removed: PUBLIC ACCOUNTING FIRM
−Removed: To the Stockholders and Board of Directors
+Added: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
+Added: To the Shareholders and Board of Directors of
Marker Therapeutics, Inc.
Opinion on the Financial Statements
−Removed: We have audited the accompanying consolidated
−Removed: balance sheet s of Marker Therapeutics, Inc.
−Removed: (the “Company”) as of December 31, 2019 and 2018, the related consolidated
−Removed: statements of operations, stockholders’
−Removed: equity (deficit) and cash flows for each of the two years in the period ended December
−Removed: 31, 2019, 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, 2019 and 2018, and
−Removed: the results of its operations and its cash flows for each of the two years in the period ended December 31, 2019, in conformity
−Removed: with accounting principles generally accepted in the United States of America.
−Removed: We also have audited, in accordance with
−Removed: the standards of the Public Company Accounting Oversight Board (United States) ("PCAOB"), the Company's internal control
−Removed: over financial reporting as of December 31, 2019, based on the criteria established in Internal Control - Integrated Framework
−Removed: issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in 2013 and our report dated March 12, 2020 ,
−Removed: expressed an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting.
+Added: We have audited the accompanying consolidated balance sheet of Marker Therapeutics, Inc.
+Added: (the “Company”) as of December 31, 2020 and 2019, the related consolidated statements of operations, stockholders’ equity (deficit) and cash flows for each of the two years in the period ended December 31, 2020, and the related notes (collectively referred to as the “financial statements”).
+Added: In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2020 and 2019, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2020, in conformity with accounting principles generally accepted 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: As more fully described in Note 2, the Company has a significant working capital deficiency, has incurred significant losses and needs to raise additional funds to meet its obligations and sustain its operations.
+Added: These conditions raise substantial doubt about the Company's ability to continue as a going concern.
+Added: Management's plans in regard to these matters are also described in Note 2.
+Added: The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
−Removed: These financial statements are the responsibility
−Removed: of the Company's management.
+Added: These financial statements are the responsibility of the Company's management.
Our responsibility is to express an opinion on the Company's financial statements based on our audits.
−Removed: We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance
−Removed: with the U.S.
−Removed: federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the
−Removed: We conducted our audit s in accordance
−Removed: with the standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audit s to obtain reasonable assurance
−Removed: about whether the financial statements are free of material misstatement, whether due to error or fraud.
−Removed: Our audit s included
−Removed: performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud,
−Removed: and performing procedures that respond to those risks.
−Removed: Such procedures included examining, on a test basis, evidence regarding
−Removed: the amounts and disclosures in the financial statements.
−Removed: Our audit s also included evaluating the accounting principles
−Removed: used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.
−Removed: We believe that our audit s provide a reasonable basis for our opinion.
−Removed: /s/ Marcum llp
−Removed: We have served as the Company’s auditor since 2014.
−Removed: March 12, 2020
−Removed: OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM ON INTERNAL CONTROL OVER FINANCIAL REPORTING
−Removed: To the Stockholders and Board
−Removed: of Directors of
−Removed: Marker Therapeutics, Inc.
−Removed: on Internal Control over Financial Reporting
−Removed: audited Marker Therapeutics, Inc.'s (the “Company”) internal control over financial reporting as of December 31, 2019,
−Removed: based on criteria established in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations
−Removed: of the Treadway Commission.
−Removed: In our opinion, the Company maintained, in all material respects, effective internal control over
−Removed: financial reporting as of December 31, 2019, based on criteria established in Internal Control – Integrated Framework
−Removed: (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
−Removed: also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”),
−Removed: the consolidated balance sheet s as of December 31, 2019 and 2018 and the related consolidated statements of operations,
−Removed: stockholders’ equity (deficit), and cash flows and the related notes for each of the two years in the period ended December
−Removed: 31, 2019 of the Company, and our report dated March 12, 2020 expressed an unqualified opinion on those financial statements.
−Removed: The Company's
−Removed: management is responsible for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness
−Removed: of internal control over financial reporting, included in the accompanying “Management Annual Report on Internal Control
−Removed: over Financial Reporting”.
−Removed: Our responsibility is to express an opinion on the Company's internal control over financial
−Removed: reporting based on our audit.
−Removed: We are a public accounting firm registered with the PCAOB and are required to be independent with
−Removed: respect to the Company in accordance with the U.S.
−Removed: federal securities laws and the applicable rules and regulations of the Securities
−Removed: and Exchange Commission and the PCAOB.
−Removed: our audit in accordance with the standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audit to obtain
−Removed: reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.
−Removed: Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial
−Removed: reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness
−Removed: of internal control based on the assessed risk.
−Removed: Our audit also included performing such other procedures as we considered necessary
−Removed: in the circumstances.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the Company in accordance with the U.S.
+Added: federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
+Added: We conducted our audits in accordance with the standards of the PCAOB.
+Added: Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
+Added: The Company 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 we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting.
+Added: Accordingly, we express no such opinion.
+Added: Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
+Added: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
+Added: Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.
We believe that our audit provides a reasonable basis for our opinion.
−Removed: and Limitations of Internal Control over Financial Reporting
−Removed: internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial
−Removed: reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.
−Removed: A company's internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance
−Removed: of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;
−Removed: (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in
−Removed: accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only
−Removed: in accordance with authorizations of management and directors of the company;
−Removed: and (3) provide reasonable assurance regarding prevention
−Removed: or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material
−Removed: effect on the financial statements.
−Removed: of the inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
−Removed: Also, projections
−Removed: of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes
−Removed: in conditions, or that degree of compliance with the policies or procedures may deteriorate.
+Added: Critical Audit Matters
+Added: Critical Audit Matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that:
+Added: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
+Added: We determined that there are no critical audit matters.
/s/ Marcum LLP
+Added: We have served as the Company’s auditor since 2014.
March 9, 2021
−Removed: therapeutics, INC.
−Removed: BALANCE SHEETS
+Added: MARKER THERAPEUTICS, INC.
+Added: CONSOLIDATED BALANCE SHEETS
Current assets:
2 unchanged sentences
Interest receivable
+Added: Other receivable
Total current assets
1 unchanged sentence
Property, plant and equipment, net
+Added: Construction in progress
Right-of-use assets, net
20 unchanged sentences
Total liabilities and stockholders' equity
−Removed: The accompanying notes are an integral part
−Removed: of these consolidated financial statements.
+Added: The accompanying notes are an integral part of these consolidated financial statements.
MARKER THERAPEUTICS, INC.
3 unchanged sentences
Operating expenses:
−Removed: Research and development - intellectual property acquired
Research and development
11 unchanged sentences
Weighted average number of common shares outstanding
−Removed: The accompanying notes are an integral
−Removed: part of these consolidated financial statements.
+Added: The accompanying notes are an integral part of these consolidated financial statements.
MARKER THERAPEUTICS, INC.
−Removed: CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
−Removed: EQUITY (DEFICIT)
+Added: CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
+Added: Additional Paid-
Stockholders'
1 unchanged sentence
( 306,105,450 )
−Removed: $ (157,420,027 )
−Removed: of common stock for research and development intellectual property
−Removed: Issuance of common stock and warrants in private placement
−Removed: Fees and legal costs relating to private placement
Stock options exercised for cash
−Removed: Stock warrants exercised for cash
+Added: Warrants exercised for cash
Stock warrants cashless exercised
Stock-based compensation
−Removed: Repurchase of common stock to pay for employee withholding taxes
−Removed: Fair value of repriced warrants as inducement
( 21,427,964 )
2 unchanged sentences
( 327,533,414 )
−Removed: Stock options exercised for cash
+Added: Issuance common stock for cash
Warrants exercised for cash
−Removed: Stock warrants cashless exercised
+Added: Issuance of common stock as commitment fee for future financing
Stock-based compensation
3 unchanged sentences
( 356,239,484 )
−Removed: $ (327,533,414 )
−Removed: The accompanying notes are an integral part
−Removed: of these consolidated financial statements.
+Added: The accompanying notes are an integral part of these consolidated financial statements.
MARKER THERAPEUTICS, INC.
9 unchanged sentences
Amortization on right-of-use assets
−Removed: Research and development - intellectual property acquired
Changes in operating assets and liabilities:
Prepaid expenses and deposits
+Added: ( 1,384,725 )
Interest receivable
6 unchanged sentences
Purchase of property and equipment
+Added: ( 3,638,849 )
+Added: Purchase of construction in progress
+Added: ( 6,789,098 )
Net cash used in investing activities
+Added: ( 10,427,947 )
Cash Flows from Financing Activities:
−Removed: Proceeds from issuance of common stock and warrants in private placement, net of offering costs
+Added: Proceeds from issuance of common stock
Proceeds from exercise of stock options
−Removed: Proceeds from exercise of warrants, net of offering costs
−Removed: Repurchase of common stock to pay for employee withholding taxes
+Added: Proceeds from exercise of warrants
Net cash provided by financing activities
−Removed: Net (decrease) increase in cash
+Added: Net decrease in cash
( 22,551,567 )
−Removed: Cash and cash equivalents at beginning of year
−Removed: Cash and cash equivalents at end of year
+Added: ( 17,842,799 )
+Added: Cash and cash equivalents at beginning of the period
+Added: Cash and cash equivalents at end of the period
For the Years Ended
Supplemental schedule of non-cash financing activities:
−Removed: Fair value of repriced warrants as inducement
+Added: Issuance of common stock as commitment fee for future financing
+Added: Recognition of right-of-use assets and lease liability from new operating lease agreements
Stock warrants cashless exercised
−Removed: The accompanying notes are an integral part
−Removed: of these consolidated financial statements.
+Added: The accompanying notes are an integral part of these consolidated financial statements.
MARKER THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FOR THE FISCAL YEARS DECEMBER 31, 2019
+Added: FOR THE FISCAL YEARS DECEMBER 31, 2020 AND 2019
NATURE OF OPERATIONS
−Removed: Marker Therapeutics, Inc., a Delaware corporation
−Removed: (the “Company”
−Removed: or “we”), is a clinical-stage immuno-oncology company specializing in the development and
−Removed: commercialization of novel T cell-based immunotherapies and innovative peptide-based vaccines for the treatment of hematological
−Removed: malignancies and solid tumor indications.
−Removed: The Company’s MultiTAA-specific T cell technology is based on the selective expansion
−Removed: of non-engineered, tumor-specific T cells that recognize tumor associated antigens, which are tumor targets, and kill tumor cells
−Removed: expressing those targets.
+Added: Marker Therapeutics, Inc., a Delaware corporation (the “Company” or “we”), is a clinical-stage immuno-oncology company specializing in the development and commercialization of novel T cell-based immunotherapies and innovative peptide-based vaccines for the treatment of hematological malignancies and solid tumor indications.
+Added: The Company’s MultiTAA-specific T cell technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens, which are tumor targets, and kill tumor cells expressing those targets.
These T cells are designed to recognize multiple tumor targets to produce broad spectrum anti-tumor activity.
The Company was incorporated in Nevada in 1992 and reincorporated in Delaware in October 2018.
−Removed: BASIS OF PRESENTATION AND MANAGEMENT PLANS
−Removed: The accompanying consolidated financial
−Removed: statements have been prepared in conformity with accounting principles generally accepted in the United States of America.
−Removed: reference in these footnotes to applicable guidance is meant to refer to the authoritative U.S.
−Removed: generally accepted accounting principles
−Removed: (“GAAP”) as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”)
−Removed: of the Financial Accounting Standards Board (“FASB”).
−Removed: The Company has not generated any revenue
−Removed: from product sales to date and, if the Company does not successfully obtain regulatory approval and commercialize any of its product
−Removed: candidates, the Company will not be able to generate product revenue or achieve profitability.
−Removed: The Company is subject to risks common
−Removed: to companies in the biotechnology industry and the future success of the Company is dependent on its ability to successfully complete
−Removed: the development of, and obtain regulatory approval for its product candidates, manage the growth of the organization, obtain additional
−Removed: financing necessary in order to develop, launch and commercialize its product candidates, and compete successfully with other companies
−Removed: in its industry.
−Removed: These financial statements are presented in United States dollars and have been prepared in accordance with accounting
−Removed: principles generally accepted in the United States of America (“GAAP”).
−Removed: In the opinion of management, the accompanying
−Removed: consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for
−Removed: a fair presentation of such annual results.
−Removed: SIGNIFICANT ACCOUNTING POLICIES
−Removed: Principles of Consolidation
−Removed: These consolidated financial statements
−Removed: include the accounts of the Company and its wholly-owned subsidiaries, Marker Cell Therapy, Inc.
−Removed: and GeneMax Pharmaceuticals Inc.
−Removed: a dormant subsidiary that wholly owns GeneMax Pharmaceuticals Canada, Inc.
−Removed: All significant intercompany balances and transactions
−Removed: are eliminated upon consolidation.
−Removed: Use of Estimates
−Removed: Preparation of the Company’s consolidated
−Removed: financial statements in conformity with GAAP requires management to make estimates and assumptions that affect certain reported
−Removed: amounts and disclosures.
−Removed: Accordingly, actual results could differ materially from those estimates.
−Removed: Significant areas requiring
−Removed: management’s estimates and assumptions include valuation allowance on deferred tax assets, determining the fair value of
−Removed: stock-based compensation and stock-based transactions, the fair value of the components of the warrant liabilities and accrued
−Removed: Liquidity, Financial Condition and
−Removed: Management’s Plans
−Removed: As of December 31, 2019, the Company had
−Removed: cash and cash equivalents of approximately $43.9 million.
−Removed: The Company’s activities since inception have consisted principally
−Removed: of acquiring product and technology rights, raising capital, and performing research and development.
−Removed: Successful completion of
−Removed: the Company’s development programs and, ultimately, the attainment of profitable operations are dependent on future events,
−Removed: including, among other things, its ability to access potential markets;
+Added: FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS
+Added: As of December 31, 2020, the Company had cash and cash equivalents of approximately $ 21.4 million.
+Added: The Company’s activities since inception have consisted principally of acquiring product and technology rights, raising capital, and performing research and development.
+Added: Successful completion of the Company’s development programs and, ultimately, the attainment of profitable operations are dependent on future events, including, among other things, its ability to access potential markets;
secure financing;
−Removed: successfully progress its product candidates
−Removed: through preclinical and clinical development;
+Added: successfully progress its product candidates through preclinical and clinical development;
obtain regulatory approval of one or more of its product candidates;
−Removed: enforce intellectual property rights;
+Added: maintain and enforce intellectual property rights;
develop a customer base;
attract, retain and motivate qualified personnel;
−Removed: and develop strategic
−Removed: alliances and collaborations.
+Added: and develop strategic alliances and collaborations.
From inception, the Company has been funded by a combination of equity and debt financings.
−Removed: The Company expects to continue to incur
−Removed: substantial losses over the next several years during its development phase.
−Removed: To fully execute its business plan, the Company will
−Removed: need to complete certain research and development activities and clinical trials.
−Removed: Further, the Company’s product candidates
−Removed: will require regulatory approval prior to commercialization.
−Removed: These activities will span many years and require substantial expenditures
−Removed: to complete and may ultimately be unsuccessful.
+Added: The Company expects to continue to incur substantial losses over the next several years during its development phase.
+Added: To fully execute its business plan, the Company will need to complete certain research and development activities and clinical trials.
+Added: Further, the Company’s product candidates will require regulatory approval prior to commercialization.
+Added: These activities will span many years and require substantial expenditures to complete and may ultimately be unsuccessful.
Any delays in completing these activities could adversely impact the Company.
−Removed: Company plans to meet its capital requirements primarily through issuances of debt and equity securities and, in the longer term,
−Removed: revenue from sales of its product candidates, if approved.
−Removed: Based on the Company’s revised clinical
−Removed: and research and development plans and its revised timing expectations related to the progress of its programs, the Company expects
−Removed: that its cash and cash equivalents as of December 31, 2019 will enable the Company to fund its operating expenses and capital expenditure
−Removed: requirements into the second quarter of 2021.
−Removed: The Company has based this estimate on assumptions that may prove to be wrong, and
−Removed: the Company could utilize its available capital resources sooner than it currently expects.
−Removed: Furthermore, the Company’s operating
−Removed: plan may change, and it may need additional funds sooner than planned in order to meet operational needs and capital requirements
−Removed: for product development and commercialization.
−Removed: Because of the numerous risks and uncertainties associated with the development
−Removed: and commercialization of the Company’s product candidates and the extent to which the Company may enter into additional collaborations
−Removed: with third parties to participate in their development and commercialization, the Company is unable to estimate the amounts of
−Removed: increased capital outlays and operating expenditures associated with its current and anticipated clinical trials.
−Removed: The Company’s
−Removed: future funding requirements will depend on many factors, as it:
+Added: The Company plans to meet its capital requirements primarily through issuances of debt and equity securities and, in the longer term, revenue from sales of its product candidates, if approved.
+Added: Based on the Company’s clinical and research and development plans and its timing expectations related to the progress of its programs, the Company expects that its cash and cash equivalents as of December 31, 2020 will enable the Company to fund its operating expenses and capital expenditure requirements into the third quarter of 2021, as such these factors raise substantial doubt regarding the Company's ability to continue as a going concern.
+Added: The Company has based this estimate on assumptions that may prove to be wrong, and the Company could utilize its available capital resources sooner than it currently expects.
+Added: Furthermore, the Company’s operating plan may change, and it may need additional funds sooner than planned in order to meet operational needs and capital requirements for product development and commercialization.
+Added: Because of the numerous risks and uncertainties associated with the development and commercialization of the Company’s product candidates and the extent to which the Company may enter into additional collaborations with third parties to participate in their development and commercialization, the Company is unable to estimate the amounts of increased capital outlays and operating expenditures associated with its current and anticipated clinical trials.
+Added: The Company’s future funding requirements will depend on many factors, as it:
● initiates or continues clinical trials of its product candidates;
5 unchanged sentences
● enhances operational, financial and information management systems and hires additional personnel, including personnel to support development of product candidates and, if a product candidate is approved, commercialization efforts.
−Removed: Research and Development –
−Removed: Intellectual Property Acquired
−Removed: The Company evaluates whether acquired
−Removed: intangible assets are a business under applicable accounting standards.
−Removed: Additionally, the Company evaluates whether the acquired
−Removed: assets have an alternative future use.
−Removed: Intangible assets that do not have alternative future use are considered acquired in-process
−Removed: research and development.
−Removed: When the acquired in-process research and development assets are not part of a business combination,
−Removed: the value of the consideration paid is expensed on the acquisition date.
−Removed: Future costs to develop these assets are recorded to research
−Removed: and development expense as they are incurred.
+Added: These factors raise substantial doubt regarding the Company’s ability to continue as a going concern.
+Added: The accompanying consolidated financial statements have been prepared on a going concern basis, which implies that the Company will continue to realize its assets and discharge its liabilities in the normal course of business.
+Added: The consolidated financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
+Added: In addition to the foregoing, based on the Company’s current assessment, the Company does not expect any material impact on its long-term liquidity due to the COVID-19 pandemic.
+Added: However, the Company will continue to assess the effect of the pandemic on its operations, including its clinical programs.
+Added: The extent to which the COVID-19 pandemic will impact the Company’s business and operations will depend on future developments that are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, the duration and effect of business disruptions and the short-term effects and ultimate effectiveness of the travel restrictions, quarantines, social distancing requirements and business closures in the United States and other countries to contain and treat the disease.
+Added: While the potential economic impact brought by, and the duration of, COVID-19 may be difficult to assess or predict, a widespread pandemic could result in significant disruption of global financial markets, reducing the Company’s ability to access capital, which could in the future negatively affect the Company’s liquidity.
+Added: In addition, a recession or market correction resulting from the spread of COVID-19 could materially affect the Company’s business and the value of its common stock.
+Added: SIGNIFICANT ACCOUNTING POLICIES
+Added: Basis of Presentation
+Added: The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America.
+Added: Any reference in these footnotes to applicable guidance is meant to refer to the authoritative U.S.
+Added: generally accepted accounting principles (“GAAP”) as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).
+Added: Principles of Consolidation
+Added: These consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Marker Cell Therapy, Inc.
+Added: and GeneMax Pharmaceuticals Inc.
+Added: – a dormant subsidiary that wholly owns GeneMax Pharmaceuticals Canada, Inc.
+Added: All significant intercompany balances and transactions are eliminated upon consolidation.
+Added: Use of Estimates
+Added: Preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect certain reported amounts and disclosures.
+Added: Accordingly, actual results could differ materially from those estimates.
+Added: Significant areas requiring management’s estimates and assumptions include valuation allowance on deferred tax assets, determining the fair value of stock-based compensation and stock-based transactions, the fair value of the components of the warrant liabilities and accrued liabilities.
Cash, Cash Equivalents and Credit Risk
−Removed: The Company considers highly liquid investments
−Removed: with a maturity of three months or less when purchased to be cash equivalents.
−Removed: Cash and cash equivalents at December 31, 2019 consisted
−Removed: of cash and certificates of deposit in institutions in the United States.
−Removed: Balances at certain institutions have exceeded Federal
−Removed: Deposit Insurance Corporation insured limits and U.S.
+Added: The Company considers highly liquid investments with a maturity of three months or less when purchased to be cash equivalents.
+Added: Cash and cash equivalents at December 31, 2020 consisted of cash and certificates of deposit in institutions in the United States.
+Added: Balances at certain institutions have exceeded Federal Deposit Insurance Corporation insured limits and U.S.
government agency securities.
−Removed: The Company maintains cash in accounts
−Removed: which are in excess of the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $250,000.
−Removed: As of December
−Removed: 31, 2019, approximately $0.1 million in cash was uninsured based upon the FDIC insurance coverage limits.
+Added: The Company maintains cash in accounts which are in excess of the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $ 250,000 .
+Added: As of December 31, 2020, approximately $ 2.7 million in cash was uninsured based upon the FDIC insurance coverage limits.
Property and Equipment
−Removed: Leasehold improvements, furniture, equipment
−Removed: and software are recorded at cost and are depreciated using the straight-line method over the estimated useful lives of the related
−Removed: assets, which range from three to five years.
−Removed: Leasehold improvements are amortized over the shorter of the
−Removed: estimated useful life or the remaining lease term.
+Added: Leasehold improvements, furniture, equipment and software are recorded at cost and are depreciated using the straight-line method over the estimated useful lives of the related assets, which range from three to five years .
+Added: Leasehold improvements are amortized over the shorter of the estimated useful life or the remaining lease term.
+Added: Property and equipment - Construction in Progress
+Added: In June 2020, the Company entered into a lease for a manufacturing facility in Houston, Texas.
+Added: In connection with the manufacturing facility, the Company has incurred costs pursuant to an agreement with a vendor to design, engineer, build and install modular cleanrooms in a manufacturing facility.
+Added: The facility's construction was completed during December 2020, and a certificate of occupancy was delivered to the Company in January 2021, and as such was placed into service in January 2021.
+Added: All costs associated with the buildout will be recorded as either manufacturing equipment and/or leasehold improvements and amortized over the estimated useful life of the asset and/or leasehold lease.
Fair Value Measurements
−Removed: The Company follows Accounting Standards
−Removed: Codification (“ASC”) 820, “Fair Value Measurements and Disclosures,”
−Removed: (“ASC 820”) for the Company’s
−Removed: financial assets and liabilities that are re-measured and reported at fair value at each reporting period and are re-measured and
−Removed: reported at fair value at least annually using a fair value hierarchy that is broken down into three levels.
−Removed: Level inputs are defined
+Added: The Company follows Accounting Standards Codification (“ASC”) 820, “Fair Value Measurements and Disclosures,” (“ASC 820”) for the Company’s financial assets and liabilities that are re-measured and reported at fair value at each reporting period and are re-measured and reported at fair value at least annually using a fair value hierarchy that is broken down into three levels.
+Added: Level inputs are defined as follows:
● Level 1 - Quoted prices (unadjusted) in active markets for identical assets and liabilities.
−Removed: Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as unadjusted quoted prices for similar
−Removed: assets and liabilities, unadjusted quoted prices in the markets that are not active, or other inputs that are observable or can
−Removed: be corroborated by observable market data for substantially the full term of the assets or liabilities.
−Removed: Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of
−Removed: the assets or liabilities, financial instruments and concentration of credit risk.
+Added: ● Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as unadjusted quoted prices for similar assets and liabilities, unadjusted quoted prices in the markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
+Added: ● Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities, financial instruments and concentration of credit risk.
Patents and Patent Application Costs
−Removed: Although the Company believes that its
−Removed: patents and underlying technology have continuing value, the amount of future benefits to be derived from the patents is uncertain.
+Added: Although the Company believes that its patents and underlying technology have continuing value, the amount of future benefits to be derived from the patents is uncertain.
Patent costs are, therefore, expensed as incurred.
Stock-Based Compensation
−Removed: The Company incurs stock-based compensation
−Removed: expense related to the issuance of common stock and stock options.
−Removed: The Company estimates the fair value of stock options granted
−Removed: using the Black-Scholes option pricing model.
−Removed: The Black-Scholes option pricing model was developed for use in estimating the fair
−Removed: value of traded options, which have no vesting restrictions and are fully transferable.
−Removed: In addition, option valuation models require
−Removed: the input of highly subjective assumptions, including the expected stock price volatility and expected option life.
−Removed: amortizes the fair value of the awards expected to vest on a straight-line basis over the requisite service period of the awards.
−Removed: Expected volatility is based on historical volatility.
−Removed: The expected life of options granted is based on historical expected life.
−Removed: The risk-free interest rate is based on the U.S.
−Removed: Treasury yield in effect at the time of grant.
−Removed: The forfeiture rate is based on
−Removed: historical data.
−Removed: The dividend yield is based on the fact that no dividends have been paid historically and none are currently expected
−Removed: to be paid in the foreseeable future:
−Removed: Expected Term —
−Removed: The expected term of options represents the period that the Company’s stock-based awards are expected to be outstanding based
−Removed: on the simplified method, which is the half-life from vesting to the end of its contractual term.
−Removed: Expected Volatility —
−Removed: The Company computes stock price volatility over expected terms based on its historical common stock trading prices.
−Removed: Risk-Free Interest Rate —
−Removed: The Company bases the risk-free interest rate on the implied yield available on U.
−Removed: Treasury zero-coupon issues with an equivalent
−Removed: remaining term.
−Removed: Expected Dividend —
−Removed: The Company has never declared or paid any cash dividends on its common shares and does not plan to pay cash dividends in the foreseeable
−Removed: future, and, therefore, uses an expected dividend yield of zero in its valuation models.
−Removed: The Company recognizes fair value of stock
−Removed: options granted to nonemployees as stock-based compensation expense over the period in which the related services are received.
+Added: The Company incurs stock-based compensation expense related to the issuance of common stock and stock options.
+Added: The Company estimates the fair value of stock options granted using the Black-Scholes option pricing model.
+Added: The Black-Scholes option pricing model was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable.
+Added: In addition, option valuation models require the input of highly subjective assumptions, including the expected stock price volatility and expected option life:
+Added: Expected Term — The expected life of stock options was estimated using the "simplified method,"
+Added: as the Company has limited historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock options grants.
+Added: The simplified method is based on the average of the vesting tranches and the contractual life of each grant.
+Added: Expected Volatility — The Company computes stock price volatility over expected terms based on its historical common stock trading prices.
+Added: Risk-Free Interest Rate — The Company bases the risk-free interest rate on the implied yield available on U.
+Added: Treasury zero-coupon issues with an equivalent remaining term.
+Added: Expected Dividend — The Company has never declared or paid any cash dividends on its common shares and does not plan to pay cash dividends in the foreseeable future, and, therefore, uses an expected dividend yield of zero in its valuation models.
+Added: The Company amortizes the fair value of the awards expected to vest on a straight-line basis over the requisite service period of the awards.
+Added: The Company recognizes fair value of stock options granted to nonemployees as stock-based compensation expense over the period in which the related services are received as if the Company had paid cash for those services.
+Added: Forfeitures are accounted for as incurred.
Research and Development Costs
−Removed: Research and development expenses consist
−Removed: of expenses incurred in performing research and development activities, including compensation and benefits for research and development
−Removed: employees and consultants, facilities expenses, overhead expenses, cost of laboratory supplies, manufacturing expenses, fees paid
−Removed: to third parties and other outside expenses.
−Removed: Research and development costs are expensed
+Added: Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for research and development employees and consultants, facilities expenses, overhead expenses, cost of laboratory supplies, manufacturing expenses, fees paid to third parties and other outside expenses.
+Added: Research and development costs are expensed as incurred.
Clinical trial and other development costs incurred by third parties are expensed as the contracted work is performed.
−Removed: The Company accrues for costs incurred as the services are being provided by monitoring the status of the clinical trial or project
−Removed: and the invoices received from its external service providers.
−Removed: The Company estimates depend on the timeliness and accuracy of the
−Removed: data provided by the vendors regarding the status of each project and total project spending.
−Removed: The Company adjusts its accrual as
−Removed: actual costs become known.
−Removed: Where contingent milestone payments are due to third parties under research and development arrangements,
−Removed: the milestone payment obligations are expensed when the milestone events are achieved.
−Removed: The Company follows the asset and liability
−Removed: method of accounting for income taxes.
−Removed: Under this method, deferred tax assets and liabilities are recognized for the future tax
−Removed: consequences attributable to differences between the financial statement carrying amounts of assets and liabilities and their respective
−Removed: tax balances.
−Removed: Potential deferred tax assets and liabilities are measured using enacted tax rates expected to apply to the taxable
−Removed: income in the years in which those differences are expected to be recovered or settled.
−Removed: The effect on potential deferred tax assets
−Removed: and liabilities of a change in tax rates is recognized in the statement of operations in the period that includes the date of allowances
−Removed: against deferred tax assets.
−Removed: Tax benefits are recognized only for tax
−Removed: positions that are more likely than not to be sustained upon examination by tax authorities.
−Removed: The amount recognized is measured
−Removed: as the largest amount of benefit that is greater than 50 percent likely to be realized upon settlement.
−Removed: A liability for “unrecognized
−Removed: tax benefits”
−Removed: is recorded for any tax benefits claimed in the Company’s tax returns that do not meet these recognition
−Removed: and measurement standards.
+Added: The Company accrues for costs incurred as the services are being provided by monitoring the status of the clinical trial or project and the invoices received from its external service providers.
+Added: The Company estimates depend on the timeliness and accuracy of the data provided by the vendors regarding the status of each project and total project spending.
+Added: The Company adjusts its accrual as actual costs become known.
+Added: Where contingent milestone payments are due to third parties under research and development arrangements, the milestone payment obligations are expensed when the milestone events are achieved.
+Added: The Company follows the asset and liability method of accounting for income taxes.
+Added: Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of assets and liabilities and their respective tax balances.
+Added: Potential deferred tax assets and liabilities are measured using enacted tax rates expected to apply to the taxable income in the years in which those differences are expected to be recovered or settled.
+Added: The effect on potential deferred tax assets and liabilities of a change in tax rates is recognized in the statement of operations in the period that includes the date of allowances against deferred tax assets.
+Added: Tax benefits are recognized only for tax positions that are more likely than not to be sustained upon examination by tax authorities.
+Added: The amount recognized is measured as the largest amount of benefit that is greater than 50 percent likely to be realized upon settlement.
+Added: A liability for “unrecognized tax benefits” is recorded for any tax benefits claimed in the Company’s tax returns that do not meet these recognition and measurement standards.
As of December 31, 2020 and 2019, no liability for unrecognized tax benefits was required to be reported.
The guidance also discusses the classification of related interest and penalties on income taxes.
−Removed: The Company’s policy is
−Removed: to record interest and penalties on uncertain tax positions as a component of income tax expense.
−Removed: No interest or penalties were
−Removed: recorded during the years ended December 31, 2019 and 2018.
+Added: The Company’s policy is to record interest and penalties on uncertain tax positions as a component of income tax expense.
+Added: No interest or penalties were recorded during the years ended December 31, 2020 and 2019.
Warrant Liability
−Removed: The Company evaluates options, warrants
−Removed: or other contracts to determine if those contracts or embedded components of those contracts qualify as derivatives to be separately
−Removed: accounted for.
−Removed: This accounting treatment requires that the carrying amounts of embedded derivatives be marked-to-market at each
−Removed: balance sheet date and carried at fair value.
−Removed: If the fair value is recorded as a liability, the change in fair value during the
−Removed: period is recorded in the Statement of Operations as either income or expense.
−Removed: Upon conversion, exercise or modification to the
−Removed: terms of a derivative instrument, the instrument is marked to fair value at the conversion date and then the related fair value
−Removed: is reclassified to equity.
−Removed: In circumstances where the embedded conversion
−Removed: option in a convertible instrument is required to be bifurcated and there are also other embedded derivative instruments in the
−Removed: convertible instrument that are required to be bifurcated, the bifurcated derivative instruments are accounted for as a single,
−Removed: compound derivative instrument.
−Removed: The classification of financial instruments,
−Removed: including whether such instruments should be recorded as liabilities or as equity, is re-assessed at the end of each reporting
−Removed: Equity instruments that are initially classified as equity that become subject to reclassification are reclassified to
−Removed: liability at the fair value of the instrument on the reclassification date.
−Removed: Derivative instrument liabilities will be classified
−Removed: in the balance sheet as current or non-current based on whether or not net-cash settlement of the derivative instrument is expected
−Removed: within 12 months of the balance sheet date.
−Removed: Management must determine whether an instrument
−Removed: (or an embedded feature) is indexed to the Company’s own stock.
−Removed: An entity should use a two-step approach to evaluate whether
−Removed: an equity-linked financial instrument (or embedded feature) is indexed to its own stock, including evaluating the instrument’s
−Removed: contingent exercise and settlement provisions.
−Removed: This exercise affects the accounting for (i) certain freestanding warrants that
−Removed: contain exercise price adjustment features and (ii) convertible notes containing full-ratchet and anti-dilution protections (iii)
−Removed: certain free-standing warrants that contain contingently putable cash settlement.
−Removed: The Company recognizes grant income in
−Removed: accordance with the terms stipulated under the grant awarded to the Company’s collaborators at the Mayo Foundation from the
+Added: The Company evaluates options, warrants or other contracts to determine if those contracts or embedded components of those contracts qualify as derivatives to be separately accounted for.
+Added: This accounting treatment requires that the carrying amounts of embedded derivatives be marked-to-market at each balance sheet date and carried at fair value.
+Added: If the fair value is recorded as a liability, the change in fair value during the period is recorded in the Statement of Operations as either income or expense.
+Added: Upon conversion, exercise or modification to the terms of a derivative instrument, the instrument is marked to fair value at the conversion date and then the related fair value is reclassified to equity.
+Added: In circumstances where the embedded conversion option in a convertible instrument is required to be bifurcated and there are also other embedded derivative instruments in the convertible instrument that are required to be bifurcated, the bifurcated derivative instruments are accounted for as a single, compound derivative instrument.
+Added: The classification of financial instruments, including whether such instruments should be recorded as liabilities or as equity, is re-assessed at the end of each reporting period.
+Added: Equity instruments that are initially classified as equity that become subject to reclassification are reclassified to liability at the fair value of the instrument on the reclassification date.
+Added: Derivative instrument liabilities will be classified in the balance sheet as current or non-current based on whether or not net-cash settlement of the derivative instrument is expected within 12 months of the balance sheet date.
+Added: Management must determine whether an instrument (or an embedded feature) is indexed to the Company’s own stock.
+Added: An entity should use a two-step approach to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock, including evaluating the instrument’s contingent exercise and settlement provisions.
+Added: This exercise affects the accounting for (i) certain freestanding warrants that contain exercise price adjustment features and (ii) convertible notes containing full-ratchet and anti-dilution protections (iii) certain free-standing warrants that contain contingently putable cash settlement.
+Added: The Company recognizes grant income in accordance with the terms stipulated under the grant awarded to the Company’s collaborators at the Mayo Foundation from the U.
Department of Defense.
In various situations, the Company receives certain payments from the U.S.
−Removed: Department of Defense for
−Removed: reimbursement of clinical supplies.
−Removed: These payments are non-refundable and are not dependent on the Company’s ongoing future
−Removed: The Company has adopted a policy of recognizing these payments when received and as revenue in accordance with Accounting
−Removed: Standards Update No.
−Removed: 2014-09, “Revenue from Contracts with Customers (Topic 606)”
−Removed: issued by the Financial Accounting
−Removed: Standards Board.
+Added: Department of Defense for reimbursement of clinical supplies.
+Added: These payments are non-refundable and are not dependent on the Company’s ongoing future performance.
+Added: The Company has adopted a policy of recognizing these payments when received and as revenue in accordance with Accounting Standards Update No.
+Added: 2014-09, “Revenue from Contracts with Customers (Topic 606)” issued by the Financial Accounting Standards Board.
Loss per Common Share
−Removed: Basic loss per share includes only the
−Removed: weighted average common shares outstanding, without consideration of potentially dilutive securities.
−Removed: Diluted loss per share includes
−Removed: the weighted average common shares outstanding and any potentially dilutive common stock equivalent shares in the calculation.
+Added: Basic loss per share includes only the weighted average common shares outstanding, without consideration of potentially dilutive securities.
+Added: Diluted loss per share includes the weighted average common shares outstanding and any potentially dilutive common stock equivalent shares in the calculation.
New Accounting Standards
−Removed: From time to time, new accounting pronouncements
−Removed: are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that we adopt as of
−Removed: the specified effective date.
−Removed: Unless otherwise discussed, the Company does not believe that the impact of recently issued standards
−Removed: that are not yet effective will have a material impact on its financial position or results of operations upon adoption.
−Removed: Recent Accounting Standards Adopted
−Removed: In February 2016, the FASB issued ASU 2016-02,
−Removed: Leases (Topic 842) in order to increase transparency and comparability among organizations by, among other provisions, recognizing
−Removed: lease assets and lease liabilities on the balance sheet for those leases classified as operating leases under previous GAAP.
−Removed: public companies, ASU 2016-02 is effective for fiscal years beginning after December 15, 2018 (including interim periods within
−Removed: those periods) using a modified retrospective approach and early adoption is permitted.
−Removed: In transition, entities may also elect
−Removed: a package of practical expedients that must be applied in its entirety to all leases commencing before the adoption date, unless
−Removed: the lease is modified, and permits entities to not reassess (a) the existence of a lease, (b) lease classification or (c) determination
−Removed: of initial direct costs, as of the adoption date, which effectively allows entities to carryforward accounting conclusions under
−Removed: previous U.S.
−Removed: In July 2018, the FASB issued ASU 2018-11, Leases (Topic 842):
−Removed: Targeted Improvements, which provides entities
−Removed: an optional transition method to apply the guidance under Topic 842 as of the adoption date, rather than as of the earliest period
−Removed: The Company adopted Topic 842 on January 1, 2019, using the optional transition method to apply the new guidance as
−Removed: of January 1, 2019, rather than as of the earliest period presented, and elected the package of practical expedients described
−Removed: Based on the analysis, on January 1, 2019, the Company recorded right of use assets of approximately $637,000, lease liability
−Removed: of approximately $670,000 and eliminated deferred rent of approximately $33,000.
−Removed: Improvements to Non-Employee Share-Based
−Removed: Payment Accounting
−Removed: In June 2018, the FASB issued ASU 2018-07
−Removed: “Improvements to Non-employee Share-Based Payment Accounting”, which simplifies the accounting for share-based payments
−Removed: granted to non-employees for goods and services.
−Removed: Under the ASU, most of the guidance on such payments to non-employees would be
−Removed: aligned with the requirements for share-based payments granted to employees.
−Removed: The amendments are effective for fiscal years beginning
−Removed: after December 15, 2019, and interim periods within fiscal years beginning after December 15, 2020.
−Removed: The Company has early adopted
−Removed: the new standard effective January 1, 2019 and the adoption of this standard did not have a material impact on the Company’s
−Removed: consolidated financial statements.
−Removed: Recent Accounting Standards Not Yet
+Added: From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that we adopt as of the specified effective date.
+Added: Unless otherwise discussed, the Company does not believe that the impact of recently issued standards that are not yet effective will have a material impact on its financial position or results of operations upon adoption.
+Added: Recent Accounting Standards Not Yet Adopted
In December 2019, the FASB issued ASU No.
−Removed: 2019-12, “Income Taxes (Topic 740):
−Removed: Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended
−Removed: to simplify various aspects related to accounting for income taxes.
−Removed: ASU 2019-12 removes certain exceptions to the general principles
−Removed: in Topic 740 and also clarifies and amends existing guidance to improve consistent application.
−Removed: This guidance is effective for
−Removed: fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted.
−Removed: The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures.
−Removed: ASSET ACQUISITION
−Removed: The Asset Acquisition
−Removed: On October 17,
−Removed: 2018, the Company completed its acquisition with Marker Cell Therapy, Inc., formerly known as Marker Therapeutics, Inc., a privately-held
−Removed: Delaware corporation (“Marker Cell”), in accordance with the terms of an Agreement and Plan of Merger and Reorganization
−Removed: dated as of May 15, 2018 (the “Merger Agreement”) by and among the Company, Timberwolf Merger Sub, Inc., a Delaware
−Removed: corporation and wholly-owned subsidiary of the Company (“Merger Sub”), and Marker.
−Removed: On October 17, 2018, pursuant to
−Removed: the Merger Agreement, Merger Sub was merged with and into Marker Cell (the “Merger”), with Marker Cell being the surviving
−Removed: corporation and becoming a wholly-owned subsidiary of the Company.
−Removed: In connection with the Merger, the Company changed its name
−Removed: to Marker Therapeutics, Inc.
−Removed: and Marker Cell changed its name to Marker Cell Therapy, Inc.
−Removed: At the effective time of the Merger,
−Removed: the former Marker Cell stockholders received (i) an aggregate of 13,914,255 shares of the Company’s common stock which equaled
−Removed: the number of shares of the Company’s common stock issued and outstanding immediately prior to the effective time of the
−Removed: Merger, and (ii) an aggregate of 5,046,003 warrants which equaled the number of the Company’s warrants and stock options
−Removed: issued and outstanding immediately prior to the effective time of the Merger.
−Removed: Securities Purchase Agreements
−Removed: On October 17, 2018, concurrent with the
−Removed: completion of the Merger, the Company issued to certain accredited investors in a private placement transaction (the “Financing”),
−Removed: an aggregate of 17,500,000 shares of its common stock, and warrants to purchase 13,437,500 shares of common stock at an exercise
−Removed: price of $5.00 per share with a five-year term, for gross proceeds of $70 million pursuant to the terms of the Securities Purchase
−Removed: Agreements, dated June 8, 2018, by and among the Company and certain accredited investors (the “Securities Purchase Agreements”).
−Removed: Accounting Treatment
−Removed: Because Marker’s intellectual property
−Removed: had not yet received regulatory approval, the $116.0 million purchase price paid for these assets was expensed in the Company’s
−Removed: statement of operations for the fiscal year ended December 31, 2018.
−Removed: The Common Stock issued for the asset acquisition was valued
−Removed: at $116.0 million which is equal to the 13,914,255 common shares issued to Marker multiplied by $8.34, the closing price of the
−Removed: Company’s Common Stock as of October 17, 2018.
+Added: 2019-12, “Income Taxes (Topic 740):
+Added: Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes.
+Added: ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application.
+Added: This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted.
+Added: The Company has adopted the new standard effective January 1, 2021 and is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures.
NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS
Net Loss per Share Applicable to Common Stockholders
−Removed: Basic loss per common share is computed
−Removed: by dividing net loss by the weighted average number of common shares outstanding during the reporting period.
−Removed: Diluted loss per
−Removed: common share is computed similarly to basic loss per common share except that it reflects the potential dilution that could occur
−Removed: if dilutive securities or other obligations to issue common stock were exercised or converted into common stock.
−Removed: The following table sets forth the computation
−Removed: of loss per share for the years ended December 31, 2019 and 2018, respectively:
+Added: Basic loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the reporting period.
+Added: Diluted loss per common share is computed similarly to basic loss per common share except that it reflects the potential dilution that could occur if dilutive securities or other obligations to issue common stock were exercised or converted into common stock.
+Added: The following table sets forth the computation of loss per share for the years ended December 31, 2020 and 2019, respectively:
For the Years Ended
4 unchanged sentences
Basic and diluted
−Removed: The following securities, rounded to the thousand, were not
−Removed: included in the diluted net loss per share calculation because their effect was anti-dilutive for the periods presented:
+Added: The following securities, rounded to the thousand, were not included in the diluted net loss per share calculation because their effect was anti-dilutive for the periods presented:
For the Years Ended
3 unchanged sentences
Potentially dilutive securities
+Added: OTHER RECEIVABLE
+Added: Pursuant to the Company’s lease agreement for its manufacturing facility, the Company incurred and paid for the construction invoices directly for both the structural improvements of the facility and the building of the manufacturing modular cleanroom (i.e.
+Added: leasehold improvements and manufacturing equipment).
+Added: At the time the construction invoices are received by the Company, a fixed asset is recorded in construction-in-progress.
+Added: In accordance with the agreement, upon completion of the facility’s construction, the Company is owed up to $ 1.0 million as reimbursement, and as such a landlord receivable is recorded, which provides for a legal right to receive construction reimbursements from the landlord for tenant improvement allowances.
+Added: The construction of the facility was completed during December 2020, and a certificate was occupancy was delivered to the Company in January 2021.
+Added: During the fiscal year ended 2020, the Company recorded a $ 1.0 million receivable in its consolidated financial statements.
+Added: The Company expects to receive the $ 1.0 million in the first half of 2021.
PROPERTY AND EQUIPMENT
−Removed: Property and equipment consist of the following
−Removed: as of December 31, 2019 and 2018, respectively:
+Added: Property and equipment consist of the following as of December 31, 2020 and 2019, respectively:
Estimated Useful Lives
3 unchanged sentences
Leasehold improvements
−Removed: Lesser of lease term or estimated
+Added: Lesser of lease term or estimated useful life
accumulated depreciation
−Removed: Property and equipment, net
−Removed: Depreciation expense for the year ended December 31, 2019 was
−Removed: Furniture and computer equipment were placed in use on January 1, 2019 therefore no depreciation expense was recorded
−Removed: during the year ended December 31, 2018.
−Removed: The Company leases office space under agreements
−Removed: classified as operating leases that expire on various dates through 2022.
−Removed: All of the Company’s lease liabilities result from
−Removed: the lease of its corporate headquarters in Houston, Texas, which expires in 2021, and its Jacksonville, Florida office space, which
−Removed: expires in 2022.
−Removed: Such leases do not require any contingent rental payments, impose any financial restrictions, or contain any residual
−Removed: value guarantees.
−Removed: Certain of the Company’s leases include renewal options and escalation clauses;
−Removed: renewal options have not
−Removed: been included in the calculation of the lease liabilities and right of use assets as the Company is not reasonably certain to exercise
−Removed: Variable expenses generally represent the Company’s share of the landlord’s operating expenses.
−Removed: does not act as a lessor or have any leases classified as financing leases.
−Removed: The Company excludes short-term leases
−Removed: having initial terms of 12 months or less from the new accounting guidance as an accounting policy election and recognizes rent
−Removed: expense on a straight-line basis over the lease term.
−Removed: During the fiscal year ended December 31, 2019, the Company had two lease
−Removed: agreements, an office at the Florida Atlantic Research and Development Authority and laboratory space located at the Texas Medical
−Removed: Center in Houston, which are included in short-term lease expense below.
−Removed: At December 31, 2019, the Company had operating
−Removed: lease liabilities of approximately $484,000 and right of use assets of approximately $455,000, which were included in the consolidated
−Removed: balance sheet.
−Removed: The following summarizes quantitative information about the
−Removed: Company’s operating leases:
−Removed: For the Year Ended
−Removed: December 31, 2019
+Added: Construction in progress
+Added: Total fixed assets, net
+Added: Depreciation expense for the years ended December 31, 2020 and 2019 was approximately $ 0.5 million and $ 0.1 million, respectively.
+Added: In June 2020, the Company entered into a lease for a manufacturing facility in Houston, Texas.
+Added: In connection with the manufacturing facility, the Company has incurred costs pursuant to an agreement with a vendor to design, engineer, build and eventually install modular cleanrooms in a manufacturing facility.
+Added: $ 6.8 million is recorded in fixed assets – construction in progress on the balance sheet as of December 31, 2020.
+Added: The completion of the facility’s construction occurred during December 2020 and the Company received its certificate of occupancy in January 2021, and as such was placed into service in January 2021.
+Added: During January 2021, all costs associated with the buildout will be recorded as either manufacturing equipment and/or leasehold improvements and amortized over the estimated useful life of the asset and/or leasehold lease.
+Added: In connection with the research facility that the Company opened during the second quarter of 2020, the Company incurred approximately $ 2.2 million of costs acquiring necessary lab equipment to carry out its experiments.
+Added: The $ 2.2 million is included in Lab equipment within fixed assets and is being depreciated over five years .
+Added: Additionally, the Company incurred $ 0.3 million in leasehold improvements relating to the research facility.
+Added: The Company entered into a new agreement for its corporate headquarters in Houston, Texas, which commenced in August of 2020.
+Added: The initial lease term is ten years with two five-year renewal options.
+Added: Fixed rent payments under the initial term are approximately $ 5.6 million.
+Added: Additionally, the Company is also responsible for its share of operating expenses.
+Added: As of December 31, 2020, the Company had remaining $ 4.1 million from the lease liability and $ 4.0 million of the related right-of-use asset resulting from the lease of its corporate headquarters.
+Added: In April 2020, the Company entered into a lease for a research facility in Houston, Texas.
+Added: The lease term is 71 months .
+Added: Fixed rent payments under the initial term are approximately $ 1.1 million.
+Added: As of December 31, 2020, the Company had remaining $ 0.8 million from the lease liability and $ 0.8 million of the related right-of-use asset resulting from the lease of its research facility.
+Added: In June 2020, the Company entered into a lease for a manufacturing facility in Houston, Texas.
+Added: The initial lease term is ten years from the rent commencement date in the fourth quarter of 2020 with two five-year renewal options.
+Added: Fixed rent payments under the initial term are approximately $ 9.8 million.
+Added: Additionally, the Company is also responsible for its share of operating expenses.
+Added: In accordance with the agreement, upon completion of the facility’s construction, the Company is owed up to $ 1.0 million as reimbursement, and as such a landlord receivable is recorded, which provides for a legal right to receive construction reimbursements from the landlord for tenant improvement allowances.
+Added: As of December 31, 2020, the Company had remaining $ 7.2 million from the lease liability and $ 5.8 million of the related right-of-use asset resulting from the lease of its manufacturing facility.
+Added: The Company also leases office space under agreements classified as operating leases that expire in 2022.
+Added: As of December 31, 2020, the Company had remaining $ 0.2 million from the lease liability and $ 0.2 million of the related right-of-use asset resulting from the lease of its Jacksonville, Florida office space, which expires in 2022.
+Added: Such leases do not require any contingent rental payments, impose any financial restrictions, or contain any residual value guarantees.
+Added: Certain of the Company’s leases include renewal options and escalation clauses;
+Added: renewal options have not been included in the calculation of the lease liabilities and right-of-use assets as the Company is not reasonably certain to exercise the options.
+Added: Variable expenses generally represent the Company’s share of the landlord’s operating expenses.
+Added: The Company does not act as a lessor or have any leases classified as financing leases.
+Added: At December 31, 2020, the Company had operating lease liabilities of approximately $ 12.3 million and right-of-use assets of approximately $ 10.8 million, which were included in the consolidated balance sheet.
+Added: The following summarizes quantitative information about the Company’s operating leases:
+Added: For the Years Ended
Operating lease expense summary:
3 unchanged sentences
Other information:
−Removed: Operating cash flows from operating leases for the twelve months ended December 31, 2019
−Removed: Right of use assets exchanged for new operating lease liabilities as of adoption date
−Removed: Weighted-average remaining lease term as of December 31, 2019 –
−Removed: operating leases
−Removed: Weighted-average discount rate as of adoption date –
−Removed: operating leases
−Removed: Maturities of the Company’s operating leases, excluding
−Removed: short-term leases, are as follows:
+Added: Operating cash flows - operating leases
+Added: Weighted-average remaining lease term – operating leases
+Added: Weighted-average discount rate as of adoption date – operating leases
+Added: Maturities of the Company’s operating leases, excluding short-term leases, are as follows:
Year ended December 31, 2021
1 unchanged sentence
Year ended December 31, 2023
+Added: Year ended December 31, 2024
+Added: Year ended December 31, 2025
Less present value discount
−Removed: Operating lease liabilities included in the Consolidated Balance Sheet at December 31, 2019
−Removed: Total rental expense under the Company’s operating leases
−Removed: was $220,000 and $175,600 for the years ended December 31, 2019 and 2018, respectively.
−Removed: accounts payable and accrued liabilities
+Added: ( 4,112,000 )
+Added: Operating lease liabilities included in the Condensed Consolidated Balance Sheet at December 31, 2020
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES
−Removed: consist of the following as of December 31, 2019 and 2018, respectively:
+Added: Accounts payable and accrued liabilities consist of the following as of December 31, 2020 and 2019, respectively:
Accounts payable
2 unchanged sentences
Technology license fees
−Removed: Investor relations fees
Total accounts payable and accrued liabilities
WARRANT LIABILITY
−Removed: A weighted average summary of quantitative
−Removed: information with respect to valuation methodology and significant unobservable inputs used for the Company’s common stock
−Removed: purchase warrants that are categorized within Level 3 of the fair value hierarchy for the years ended 2019 and 2018, respectively:
+Added: A weighted average summary of quantitative information with respect to valuation methodology and significant unobservable inputs used for the Company’s common stock purchase warrants that are categorized within Level 3 of the fair value hierarchy for the years ended 2020 and 2019, respectively:
Weighted Average Inputs
5 unchanged sentences
Dividend yield (per share)
−Removed: The foregoing assumptions are recalculated
−Removed: every reporting period and are subject to change based primarily on management’s assessment of the probability of the events
−Removed: described occurring.
+Added: The foregoing assumptions are recalculated every reporting period and are subject to change based primarily on management’s assessment of the probability of the events described occurring.
Accordingly, changes to these assessments could materially affect the valuations.
−Removed: The following table presents changes in Level 3 warrant liabilities,
−Removed: reflected in accrued expenses measured at fair value for the years ended December 31, 2019 and 2018, respectively:
−Removed: Balance –
−Removed: January 1, 2018
+Added: The following table presents changes in Level 3 warrant liabilities, reflected in accrued expenses measured at fair value for the years ended December 31, 2020 and 2019, respectively:
+Added: Balance - January 1, 2019
Change in fair value of warrant liability
−Removed: Balance –
−Removed: December 31, 2018
+Added: Balance – December 31, 2019
Change in fair value of warrant liability
−Removed: Balance –
−Removed: December 31, 2019
−Removed: VALUE MEASUREMENTS
−Removed: Financial assets and liabilities measured
−Removed: at fair value on a recurring basis are summarized below and disclosed on the balance sheet under warrant liability:
+Added: Balance – December 31, 2020
+Added: FAIR VALUE MEASUREMENTS
+Added: Financial assets and liabilities measured at fair value on a recurring basis are summarized below and disclosed on the balance sheet under Warrant liability:
Fair value measured at December 31, 2020
14 unchanged sentences
Warrant liability
−Removed: There were no transfers between Level 1,
−Removed: 2 or 3 during the years ended December 31, 2019 and 2018, respectively.
−Removed: The valuation of warrants is subjective
−Removed: and is affected by changes in inputs to the valuation model including the price per share of common stock, the historical volatility
−Removed: of the stock price, risk-free rates based on U.
+Added: There were no transfers between Level 1, 2 or 3 during the years ended December 31, 2020 and 2019, respectively.
+Added: The valuation of warrants is subjective and is affected by changes in inputs to the valuation model including the price per share of common stock, the historical volatility of the stock price, risk-free rates based on U.
Treasury security yields, the expected term of the warrants and dividend yield.
Changes in these assumptions can materially affect the fair value estimate.
−Removed: The Company could ultimately incur amounts to settle
−Removed: the warrant at a cash settlement value that is significantly different than the carrying value of the liability on the financial
−Removed: The Company will continue to classify the fair value of the warrants as a liability until the warrants are exercised,
−Removed: expire, or are amended in a way that would no longer require these warrants to be classified as a liability.
−Removed: Changes in the fair
−Removed: value of the common stock warrants liability are recognized as a component of other income (expense) in the Statements of Operations.
−Removed: The net cash settlement value at the time
−Removed: of any future transactions, where the Company consolidates or merges with another entity, will depend upon the value of the following
−Removed: inputs at that time:
−Removed: the consideration value per share of the Company’s common stock, the volatility of the Company’s
−Removed: common stock, the remaining term of the warrant from announcement date, the risk-free interest rate based on U.
−Removed: Treasury security
−Removed: yields, and the Company’s dividend yield.
−Removed: The warrant requires use of a volatility assumption equal to the greater of 100%
−Removed: and the 100-day volatility function determined as of the trading day immediately following announcement of a Fundamental Transaction.
−Removed: stockholders’
+Added: The Company could ultimately incur amounts to settle the warrant at a cash settlement value that is significantly different than the carrying value of the liability on the financial statements.
+Added: The Company will continue to classify the fair value of the warrants as a liability until the warrants are exercised, expire, or are amended in a way that would no longer require these warrants to be classified as a liability.
+Added: Changes in the fair value of the common stock warrants liability are recognized as a component of other income (expense) in the Statements of Operations.
+Added: The net cash settlement value at the time of any future transactions, where the Company consolidates or merges with another entity, will depend upon the value of the following inputs at that time:
+Added: the consideration value per share of the Company’s common stock, the volatility of the Company’s common stock, the remaining term of the warrant from announcement date, the risk-free interest rate based on U.
+Added: Treasury security yields, and the Company’s dividend yield.
+Added: The warrant requires use of a volatility assumption equal to the greater of 100% and the 100-day volatility function determined as of the trading day immediately following announcement of a Fundamental Transaction.
+Added: STOCKHOLDERS’ EQUITY
Preferred Stock
−Removed: The Company has authorized up to 5,000,000
−Removed: shares of preferred stock, $0.001 par value per share, for issuance.
−Removed: The preferred stock will have such rights, privileges and
−Removed: restrictions, including voting rights, dividend conversion rights, redemption privileges and liquidation preferences, as shall
−Removed: be determined by the Company’s board of directors upon its issuance.
+Added: The Company has authorized up to 5,000,000 shares of preferred stock, $ 0.001 par value per share, for issuance.
+Added: The preferred stock will have such rights, privileges and restrictions, including voting rights, dividend conversion rights, redemption privileges and liquidation preferences, as shall be determined by the Company’s board of directors upon its issuance.
To date, the Company has not issued any preferred shares.
−Removed: The Company has authorized up to 150,000,000
−Removed: shares of common stock, $0.001 par value per share, for issuance.
+Added: The Company has authorized up to 150,000,000 shares of common stock, $ 0.001 par value per share, for issuance.
Significant 2020 and 2019 common stock transactions were as follows:
2020 Common Stock Transactions
−Removed: Consulting Arrangements
−Removed: During the twelve months ended December
−Removed: 31, 2019, the Company issued 47,400 shares of common stock in connection with consulting agreements.
−Removed: The fair value of the common
−Removed: stock of approximately $265,000 was recognized as stock-based compensation expense in general and administrative expenses.
+Added: Exercise of Stock Warrants
+Added: During the year ended December 31, 2020, certain outstanding warrants were exercised for 0.5 million shares of common stock providing aggregate proceeds to the Company of approximately $ 0.6 million.
Board Compensation
−Removed: During the twelve months ended December
−Removed: 31, 2019, the Company issued an aggregate of 29,040 shares of common stock to its non-employee directors.
−Removed: The fair value of the
−Removed: common stock of approximately $174,000 was recognized as stock-based compensation expense in general and administrative expenses.
+Added: During the year ended December 31, 2020, the Company issued an aggregate of 0.1 million shares of common stock to its non-employee directors.
+Added: The fair value of the common stock of approximately $ 0.2 million was recognized as a component of stock-based compensation expense in general and administrative expenses.
+Added: Aspire Capital
+Added: On February 28, 2020, the Company entered into a common stock purchase agreement (the “Purchase Agreement”) with Aspire Capital Fund, LLC (“Aspire Capital”) which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $ 30.0 million of shares of the Company’s common stock over the 30-month term of the purchase agreement.
+Added: In consideration for entering into the purchase agreement, the Company issued to Aspire Capital 0.3 million shares of the Company’s common stock as a commitment fee.
+Added: The Company recorded the commitment fee to additional paid in capital.
+Added: As of December 31, 2020, Aspire Capital had purchased 4.1 million shares under the Purchase Agreement, providing aggregate proceeds to the Company of approximately $ 6.2 million.
2019 Common Stock Transactions
−Removed: Pursuant to the Merger discussed in Note
−Removed: 4 above, the Company issued 13,914,255 shares of common stock to shareholders of Marker Cell Therapy, Inc.
−Removed: The fair market value
−Removed: of the shares issued pursuant to the merger was $116.0 million.
−Removed: Securities Purchase Agreements
−Removed: Pursuant to the financing discussed in
−Removed: Note 4 above, the Company issued 17,500,000 shares of its common stock to the participating accredited investors.
−Removed: Net proceeds,
−Removed: after transaction offering costs of $6.2 million, were $63.8 million.
−Removed: Common Stock Purchase Agreement
−Removed: On May 14, 2018, the Company’s largest
−Removed: stockholder Eastern Capital Limited entered into a Common Stock Purchase Agreement with the Company pursuant to which it purchased
−Removed: 1,300,000 shares of common stock at a price per share of $2.40 providing gross proceeds to the Company of $3.12 million.
−Removed: Exercise and Repricing of Warrants
−Removed: Held by Existing Institutional Investors
−Removed: On May 14, 2018, certain institutional
−Removed: holders of outstanding warrants entered into Warrant Exercise Agreements with the Company that provide for an amendment to the
−Removed: exercise price of the warrants being exercised at $2.50 per share.
−Removed: Upon closing of the Warrant Exercise Agreements, such institutional
−Removed: holders immediately exercised warrants for 782,505 shares of common stock providing aggregate proceeds to the Company of approximately
−Removed: $2.0 million.
−Removed: The fair value relating to the modification
−Removed: of exercise prices on the repriced and exercised warrants was treated as deemed dividend on the statement of stockholders’
−Removed: equity of $728,000.
−Removed: A weighted average summary of quantitative
−Removed: information with respect to valuation methodology and significant unobservable inputs used for the Company’s common stock
−Removed: purchase warrants that are included in the modification is as follows:
−Removed: Weighted Average Inputs
−Removed: Before Modification
−Removed: After Modification
−Removed: Exercise price
−Removed: Contractual term (years)
−Removed: Volatility (annual)
−Removed: Risk-free rate
−Removed: Dividend yield (per share)
−Removed: Exercise of Stock Warrants
−Removed: In addition to the exercise and repricing
−Removed: of warrants discussed above, during the twelve months ended December 31, 2018, certain outstanding warrants were exercised by warrant
−Removed: holders providing aggregate proceeds to the Company of approximately $2.4 million and resulted in the issuance of 716,819 shares
−Removed: of common stock.
−Removed: Additionally, 280,760 of the stock warrants
−Removed: exercised were exercised on a cashless basis, which resulted in approximately 204,000 of warrant shares being cancelled due to
−Removed: use of cashless exercise provisions.
−Removed: Exercise of Stock Options
−Removed: In January 2018, 10,416 shares of common
−Removed: stock were issued pursuant to stock option exercises at an exercise price equal to $1.74 per share.
Consulting Arrangements
−Removed: During the twelve months ended December
−Removed: 31, 2018, the Company issued 274,012 shares of common stock in connection with consulting agreements.
−Removed: The fair value of the common
−Removed: stock of approximately $1.8 million was recognized as stock-based compensation expense, $1.7 million in general and administrative
−Removed: expenses and $0.1 million in research and development expenses.
−Removed: 2018 Management and Board Compensation
−Removed: During the twelve months ended December
−Removed: 31, 2018, the Company issued 53,774 shares of common stock in connection with board of director and management agreements.
−Removed: fair value of the common stock of approximately $0.5 million was recognized as stock-based compensation expense in general and
−Removed: administrative expenses.
−Removed: 7,561 shares of common stock, with a fair value of $0.1 million, were withheld to satisfy certain payroll
−Removed: liabilities, as applicable to an award to a former director.
+Added: During the year ended December 31, 2019, the Company issued 0.05 million shares of common stock in connection with consulting agreements.
+Added: The fair value of the common stock of approximately $ 0.3 million was recognized as stock-based compensation expense in general and administrative expenses.
+Added: Board Compensation
+Added: During the year ended December 31, 2019, the Company issued an aggregate of 0.03 million shares of common stock to its non-employee directors.
+Added: The fair value of the common stock of approximately $ 0.2 million was recognized as stock-based compensation expense in general and administrative expenses.
Share Purchase Warrants
−Removed: A summary of the Company’s share purchase warrants as
−Removed: of December 31, 2019 and 2018, respectively, and changes during the period is presented below:
+Added: A summary of the Company’s share purchase warrants as of December 31, 2020 and 2019, respectively, and changes during the period is presented below:
Weighted Average
7 unchanged sentences
Exercised for cash
−Removed: Cashless exercised
+Added: Cashless exercise
Expired or cancelled
Balance - December 31, 2019
−Removed: Warrants granted
Exercised for cash
−Removed: Cashless exercise
Expired or cancelled
+Added: ( 1,376,000 )
Balance - December 31, 2020
1 unchanged sentence
Exercise of Stock Warrants
−Removed: During the twelve months ended December
−Removed: 31, 2019, certain outstanding warrants were exercised for 190,258 shares of common stock providing aggregate proceeds to the Company
−Removed: of approximately $759,000.
−Removed: Additionally, during the twelve months
−Removed: ended December 31, 2019, the Company issued 9,449 shares of common stock upon cashless exercises of stock warrants, which resulted
−Removed: in cancellation of 7,211 shares of common stock subject to such warrants.
+Added: During the year ended December 31, 2020, certain outstanding warrants were exercised for 0.5 million shares of common stock providing aggregate proceeds to the Company of approximately $ 0.6 million.
2019 Warrant Transactions
−Removed: Pursuant to the Merger discussed in Note
−Removed: 4 above, the Company issued 5,046,003 stock warrants to shareholders of Marker Cell Therapy, Inc.
−Removed: at an exercise price of $2.99
−Removed: per share with a five-year term.
−Removed: Securities Purchase Agreements
−Removed: Pursuant to the financing discussed in
−Removed: Note 4 above, the Company issued 13,437,500 stock warrants to certain accredited investors at an exercise price of $5.00 per share
−Removed: with a five-year term.
−Removed: Exercise and Repricing of Warrants
−Removed: Held by Existing Institutional Investors
−Removed: On May 14, 2018, certain institutional
−Removed: holders of outstanding warrants entered into Warrant Exercise Agreements with the Company that provide for an amendment to the
−Removed: exercise price of the warrants being exercised at $2.50 per share.
−Removed: Upon closing of the Warrant Exercise Agreements, such institutional
−Removed: holders immediately exercised warrants for 782,505 shares of common stock providing aggregate proceeds to the Company of approximately
−Removed: $2.0 million.
−Removed: The fair value relating to the modification
−Removed: of exercise prices on the repriced and exercised warrants was treated as deemed dividend on the statement of stockholders’
−Removed: equity of $728,000.
−Removed: A weighted average summary of quantitative
−Removed: information with respect to valuation methodology and significant unobservable inputs used for the Company’s common stock
−Removed: purchase warrants that are included in the modification is as follows:
−Removed: Weighted Average Inputs
−Removed: Before Modification
−Removed: After Modification
−Removed: Exercise price
−Removed: Contractual term (years)
−Removed: Volatility (annual)
−Removed: Risk-free rate
−Removed: Dividend yield (per share)
Exercise of Stock Warrants
−Removed: In addition to the exercise and repricing
−Removed: of warrants discussed above, during the twelve months ended December 31, 2018, certain outstanding warrants were exercised by warrant
−Removed: holders providing aggregate proceeds to the Company of approximately $2.4 million and resulted in the issuance of 716,819 shares
−Removed: of common stock.
−Removed: Additionally, 280,760 of the stock warrants exercised were exercised
−Removed: on a cashless basis, which resulted in approximately 204,000 of warrant shares being cancelled due to use of cashless exercise
+Added: During the year ended December 31, 2019, certain outstanding warrants were exercised for 0.2 million shares of common stock providing aggregate proceeds to the Company of approximately $ 0.8 million.
STOCK OPTION PLANS
−Removed: Options to Purchase Shares of Common
−Removed: 2014 Stock Omnibus Plan
−Removed: On March 19, 2014, the Board adopted
−Removed: the 2014 Omnibus Stock Option Plan (“2014 Plan”), which replaced the 2009 Stock Incentive Plan.
−Removed: The 2014 Plan allowed
−Removed: for grants of stock options, restricted shares, stock bonuses and other equity-based awards to employees and non-employee directors
−Removed: of the Company.
−Removed: Awards under the 2014 Plan may be at prices and for terms as determined by the Board of Directors and may have
−Removed: vesting requirements as determined by the Board, provided that the exercise price for any stock option must be at least equal to
−Removed: the fair market value (as defined in the 2014 Plan) of a share of the stock on the grant date.
−Removed: Once granted, the exercise price
−Removed: of an option may not be reduced without the approval of the Company’s stockholders, other than under certain limited circumstances
−Removed: such as a stock split or take any other action with respect to a stock option that would be treated as a repricing under the rules
−Removed: and regulations of the New York Stock Exchange.
−Removed: The 2014 Plan was amended in February 2015
−Removed: to provide for grants to consultants, and again in November 2015 to (i) increase the number of shares reserved for issuance
−Removed: under the Plan to 0.6 million shares;
−Removed: (ii) provide the Board and Committee administering the Plan with full discretion on
−Removed: the vesting period for Service-Vesting Awards under the Plan, including the grant of Awards with less than the Minimum Vesting
−Removed: Requirement (as such terms are defined in the Plan), and (iii) provide the Board and Committee administering the Plan with
−Removed: the ability to grant stock bonuses to executive officers.
−Removed: On August 29, 2017, the 2014 Plan was amended
−Removed: to increase the shares reserved under the Plan to 1.4 million shares, and on October 16, 2018 the 2014 Plan was amended to increase
−Removed: the shares reserved under the Plan to 8.0 million shares.
−Removed: As of December 31, 2019, approximately 2.5 million options are available
−Removed: to be issued from the 2014 Plan.
+Added: Options to Purchase Shares of Common Stock
+Added: 2020 Equity Incentive Plan
+Added: On May 19, 2020, the Board adopted the 2020 Equity Incentive Plan ("2020 Plan") which replaced the 2014 Omnibus Stock Option Plan (“2014 Plan”).
+Added: The 2020 Plan allows for grants of stock options, restricted shares, stock bonuses and other equity-based awards to employees and non-employee directors of the Company.
+Added: Awards under the 2020 Plan may be at prices and for terms as determined by the Board of Directors and may have vesting requirements as determined by the Board, provided that the exercise price for any stock option must be at least equal to the fair market value (as defined in the 2020 Plan) of a share of the stock on the grant date.
+Added: Once granted, the exercise price of an option may not be reduced without the approval of the Company’s stockholders, other than under certain limited circumstances such as a stock split or take any other action with respect to a stock option that would be treated as a repricing under the rules and regulations of the New York Stock Exchange.
+Added: Options granted under the 2020 Plan have a maximum term of ten years from the date of grant.
+Added: Options granted in 2020 and 2019 generally vest over four years .
+Added: As of December 31, 2020, approximately 4.7 million options are available to be issued from the 2020 Plan.
+Added: 2014 Omnibus Stock Ownership Plan
+Added: The 2014 Plan, which the Board adopted on May 19, 2020 and subsequently amended from time to time, allowed for grants of stock options, restricted shares, stock bonuses and other equity-based awards to employees and non-employee directors of the Company.
+Added: The terms of the 2014 plan are substantially identical to the terms of the 2020 Plan described above.
Stock Options
−Removed: A summary of the Company’s stock option activity is as
−Removed: follows for stock options:
+Added: A summary of the Company’s stock option activity is as follows for stock options:
+Added: Weighted Average
+Added: Weighted Average
+Added: Total Intrinsic
Number of Shares
−Removed: Weighted Average Exercise Price
−Removed: Total Intrinsic Value
−Removed: Weighted Average Remaining Contractual Life (in years)
+Added: Exercise Price
+Added: Life (in years)
Outstanding as of January 1, 2020
Outstanding as of December 31, 2020
−Removed: Outstanding as of December 31, 2019
Options vested and exercisable
−Removed: The Black-Scholes option pricing model
−Removed: is used to estimate the fair value of stock options granted under the Company’s share-based compensation plans.
−Removed: average assumptions used in calculating the fair values of stock options that were granted during the years ended December 31,
−Removed: 2019 and 2018, respectively, were as follows:
+Added: The Black-Scholes option pricing model is used to estimate the fair value of stock options granted under the Company’s share-based compensation plans.
+Added: The weighted average assumptions used in calculating the fair values of stock options that were granted during the years ended December 31, 2020 and 2019, respectively, were as follows:
For the Years Ended
4 unchanged sentences
Expected dividend rate
−Removed: The following table sets forth stock-based
−Removed: compensation expenses recorded during the respective periods:
+Added: The following table sets forth stock-based compensation expenses recorded during the respective periods:
For the Years Ended
3 unchanged sentences
Total stock compensation expenses
−Removed: At December 31, 2019, the total stock-based
−Removed: compensation cost related to unvested awards not yet recognized was $14.9 million.
−Removed: The expected weighted average period compensation
−Removed: costs to be recognized was 3.0 years.
+Added: At December 31, 2020, the total stock-based compensation cost related to unvested awards not yet recognized was $ 10.6 million.
+Added: The expected weighted average period compensation costs to be recognized was 2.2 years.
Future option grants will impact the compensation expense recognized.
−Removed: During the years ended December 31, 2019
−Removed: and 2018, the Company received $0.2 million of a grant awarded to Mayo Foundation from the U.S.
−Removed: Department of Defense for the Phase
−Removed: II Clinical Trial of TPIV200.
−Removed: The grant compensated the Company for clinical supplies manufactured and provided by the Company
−Removed: for the clinical study.
+Added: During the years ended December 31, 2020 and 2019, the Company received $ 0.5 million and $ 0.2 million, respectively, of a grant awarded to Mayo Foundation from the U.S.
+Added: Department of Defense for the Phase II Clinical Trial of TPIV200.
+Added: The grant compensated the Company for clinical supplies manufactured and provided by the Company for the clinical study.
In accordance with Accounting Standards Update No.
−Removed: 2014-09, “Revenue from Contracts with Customers
−Removed: (Topic 606)”
−Removed: issued by the Financial Accounting Standards Board, the Company recorded the $0.2 million of grant income as
+Added: 2014-09, “Revenue from Contracts with Customers (Topic 606)” issued by the Financial Accounting Standards Board, the Company recorded the $ 0.5 million and $ 0.2 million, respectively, of grant income as revenue.
COMMITMENTS AND CONTINGENCIES
−Removed: An arbitration proceeding was brought against the Company before
−Removed: the Financial Industry Regulatory Authority, Inc.
−Removed: by a broker seeking to be paid approximately $1 million as compensation for two
−Removed: 2018 transactions, a warrant conversion and a private placement brokered by another broker.
−Removed: The broker’s claims are based
−Removed: on a placement agent agreement for a private placement it brokered in 2017, under which it alleges it is entitled to compensation
−Removed: for the 2018 transactions.
−Removed: The Company believes it has defenses to all of the allegations and intends to vigorously defend itself
−Removed: in this matter.
+Added: An arbitration proceeding was brought against the Company before the Financial Industry Regulatory Authority, Inc.
+Added: by a broker seeking to be paid approximately $ 1.0 million as compensation for two financing transactions that occurred in 2018, a warrant conversion and a private placement brokered by another broker.
+Added: The broker’s claims are based on a placement agent agreement for a private placement it brokered in 2017, under which it alleges it is entitled to compensation for the 2018 transactions.
+Added: The Company believes it has defenses to all of the allegations and intends to vigorously defend itself in this matter.
LEGAL PROCEEDINGS
−Removed: From time to time, the Company may be party
−Removed: to ordinary, routine litigation incidental to their business.
−Removed: The Company knows of no material, active or pending legal proceedings
−Removed: against the Company, nor is the Company involved as a plaintiff in any material proceeding or pending litigation.
−Removed: proceedings in which any of the Company’s directors, officers or affiliates, or any registered or beneficial shareholder,
−Removed: is an adverse party or has a material interest adverse to the Company’s interest.
+Added: From time to time, the Company may be party to ordinary, routine litigation incidental to their business.
+Added: The Company knows of no material, active or pending legal proceedings against the Company, nor is the Company involved as a plaintiff in any material proceeding or pending litigation.
+Added: There are no proceedings in which any of the Company’s directors, officers or affiliates, or any registered or beneficial shareholder, is an adverse party or has a material interest adverse to the Company’s interest.
RELATED PARTY TRANSACTIONS
−Removed: The following table sets forth related
−Removed: party transaction expenses recorded during the respective periods:
+Added: The following table sets forth related party transaction expenses recorded for the years ended December 31, 2020 and 2019, respectively.
For the Years Ended
−Removed: Research and development
−Removed: General and administrative
−Removed: Sponsored Research Agreement with
−Removed: The Baylor College of Medicine (“BCM”) .
−Removed: On November 16, 2018, in furtherance of the BCM License Agreement and
−Removed: as contemplated by the terms thereof, the Company entered in a Sponsored Research Agreement (“SRA”) with BCM, which
−Removed: provided for the conduct of research for the Company by credentialed personnel at BCM’s Center for Cell and Gene Therapy.
−Removed: During the years ended December 31, 2019
−Removed: and 2018, the Company incurred approximately $69,000 and $77,000, respectively, to BCM under the SRA.
−Removed: Clinical Supply Agreement with BCM .
−Removed: On September 9, 2019, in furtherance of the BCM License Agreement and as contemplated by the terms thereof, the Company entered
−Removed: in a Clinical Supply Agreement (“CSA”) with BCM, which provided for BCM to provide to the Company multi tumor antigen
−Removed: specific products.
−Removed: During the year ended December 31, 2019,
−Removed: the Company did not incur any expenses under the CSA.
+Added: Baylor College of Medicine
+Added: Bio-Techne Corporation
+Added: Total Research and development
+Added: Agreements with The Baylor College of Medicine (“BCM”) .
+Added: In November 2018 and February 2020, the Company entered in Sponsored Research Agreements with BCM, which provided for the conduct of research for the Company by credentialed personnel at BCM’s Center for Cell and Gene Therapy.
+Added: In September 2019, the Company entered in a Clinical Supply Agreement with BCM, which provided for BCM to provide to the Company multi tumor antigen specific products.
+Added: In October 2019, the Company entered in a Workforce Grant Agreement with BCM, which provided for BCM to provide to the Company manpower costs of projects for manufacturing, quality control testing and validation run activities.
+Added: In August 2020, the Company entered in a Clinical Trial Agreement with BCM, which provided for BCM to provide to the Company investigator-initiated research studies.
+Added: Purchases from Bio-Techne Corporation .
+Added: The Company is currently utilizing Bio-Techne Corporation and two of its brands for the purchases of reagents, primarily cytokines.
+Added: David Eansor is a member of the Company's board of directors and is serving as the President of the Protein Sciences Segment of Bio-Techne Corporation.
Consulting Agreement with Dr.
−Removed: On October 19, 2018, after the closing of the Company’s merger, the Company entered into a consulting agreement
−Removed: Juan Vera, a member of the Company’s board of directors, to serve as the Company’s Chief Development Officer.
+Added: On October 19, 2018, after the closing of the Company’s merger, the Company entered into a consulting agreement with Dr.
+Added: Juan Vera, a member of the Company’s board of directors, to serve as the Company’s Chief Development Officer.
On September 1, 2019, Dr.
Vera became an employee of the Company and his consulting agreement was terminated.
−Removed: During the years ended December 31, 2019
−Removed: and 2018, the Company incurred approximately $233,000 and $61,000, respectively, of expenses under Dr.
−Removed: Vera’s consulting
−Removed: The Company has no income tax expense due
−Removed: to operating losses incurred for the years ended December 31, 2019 and 2018.
−Removed: The effects of temporary differences that give rise to significant
−Removed: portions of the deferred tax assets as of December 31, 2019 and 2018 are as follows:
+Added: The Company has no income tax expense due to operating losses incurred for the years ended December 31, 2020 and 2019.
+Added: The effects of temporary differences that give rise to significant portions of the deferred tax assets as of December 31, 2020 and 2019 are as follows:
For the Years Ended
1 unchanged sentence
Net Operating Loss Carryforward
−Removed: Stock-Based Compensation
+Added: Stock Compensation
License Agreements
7 unchanged sentences
Deferred Tax Liabilities
+Added: Right-of-Use Assets
+Added: ( 2,380,000 )
Total Deferred Tax Liabilities
+Added: ( 2,380,000 )
Net Deferred Tax Assets/(Liabilities)
−Removed: The Company assesses the likelihood that
−Removed: deferred tax assets will be realized.
+Added: The Company assesses the likelihood that deferred tax assets will be realized.
To the extent that realization is not likely, a valuation allowance is established.
−Removed: upon the history of losses, management believes that it is more likely than not that future benefits of deferred tax assets will
−Removed: not be realized and has established a full valuation allowance for the years ended December 31, 2019 and 2018.
−Removed: The valuation allowance
−Removed: increased by $4.7 million as of December 31, 2019.
−Removed: The Company has research and development tax credit carryforwards of $730,000
−Removed: available to offset future federal income taxes.
+Added: Based upon the history of losses, management believes that it is more likely than not that future benefits of deferred tax assets will not be realized and has established a full valuation allowance for the years ended December 31, 2020 and 2019.
+Added: The valuation allowance increased by $ 5.1 million as of December 31, 2020.
+Added: The Company has research and development tax credit carryforwards of $ 0.7 million available to offset future federal income taxes.
The research and development tax credit carryforwards begin to expire in 2030.
−Removed: The Company has approximately $73.8 million
−Removed: of federal and $47.4 million of state Net Operating Losses (“NOL”s) that may be available to offset future taxable
−Removed: income, if any.
+Added: The Company has approximately $ 97.2 million of federal and $ 39.0 million of state Net Operating Losses (“NOL”s) that may be available to offset future taxable income, if any.
The federal net operating loss carryforwards of $ 41.6 million, if not utilized, will expire between 2029 and 2037 .
−Removed: The federal net operating loss carryforwards of $31.9 million generated in 2018 and thereafter are subject to an 80% limitation
−Removed: on taxable income, do not expire and will carry forward indefinitely.
−Removed: The state net operating loss carryforwards of $21.9 million,
−Removed: if not utilized, will begin to expire in 2035.
−Removed: The state net operating loss carryforwards of $25.5 million generated in 2018 and
−Removed: thereafter are subject to an 80% limitation on taxable income, do not expire and will carry forward indefinitely.
−Removed: In accordance with Section 382 of the Internal
−Removed: Revenue code, the usage of the Company’s net operating loss carryforwards may be limited in the event of a change in ownership.
+Added: The federal net operating loss carryforwards of $ 55.6 million generated in 2018 and thereafter are subject to an 80 % limitation on taxable income, do not expire and will carry forward indefinitely.
+Added: The state net operating loss carryforwards of $ 21.9 million, if not utilized, will begin to expire in 2035.
+Added: The state net operating loss carryforwards of $ 17.1 million generated in 2018 and thereafter are subject to an 80 % limitation on taxable income, do not expire and will carry forward indefinitely.
+Added: In accordance with Section 382 of the Internal Revenue code, the usage of the Company’s net operating loss carryforwards may be limited in the event of a change in ownership.
A full Section 382 analysis has not been prepared and NOLs could be subject to limitation under Section 382.
−Removed: The Company’s income tax returns
−Removed: for 2015 to 2018 are still open and subject to audit.
−Removed: In addition, net operating losses arising from prior years are also subject
−Removed: to examination at the time they are utilized in future years.
−Removed: For the years ended December 31, 2019 and
−Removed: 2018, the expected tax expense (benefit) based on the U.
−Removed: federal statutory rate is reconciled with the actual tax provision
−Removed: (benefit) as follows:
−Removed: For the Years Ended
−Removed: Pretax Income/(Loss)
−Removed: Pretax Income/(Loss)
+Added: The Company’s income tax returns for 2016 to 2019 are still open and subject to audit.
+Added: In addition, net operating losses arising from prior years are also subject to examination at the time they are utilized in future years.
+Added: For the years ended December 31, 2020 and 2019, the expected tax expense (benefit) based on the U.
+Added: federal statutory rate is reconciled with the actual tax provision (benefit) as follows:
+Added: For the Years Ended December 31,
federal statutory rate
4 unchanged sentences
Permanent Differences
−Removed: - Non-deductible write-off of acquired R&D expenses
- Change in fair value of derivative liabilities
3 unchanged sentences
Income tax provision/(benefit)
−Removed: ASC 740 prescribes a recognition threshold
−Removed: and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken
−Removed: in a tax return.
−Removed: For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination
−Removed: by taxing authorities.
+Added: ASC 740 prescribes a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return.
+Added: For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities.
As of December 31, 2020, and 2019, there were no unrecognized tax benefits.
−Removed: The Company recognizes accrued
−Removed: interest and penalties as income tax expense.
−Removed: No amounts were accrued for the payment of interest and penalties at December 31,
−Removed: 2019 and 2018.
−Removed: The Company is currently not aware of any issues under review that could result in significant payments, accruals
−Removed: or material deviation from its position in the next year.
−Removed: Aspire Common Stock Purchase Agreement
−Removed: On February 28, 2020, the Company entered
−Removed: into a common stock purchase agreement (the “Purchase Agreement”) with Aspire Capital Fund, LLC (“Aspire Capital”)
−Removed: which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed
−Removed: to purchase up to an aggregate of $30.0 million of shares of the Company’s common stock over the 30-month term of the Purchase
−Removed: In consideration for entering into the Purchase Agreement, concurrently with the execution of the Purchase Agreement,
−Removed: the Company issued to Aspire Capital 345,357 shares of the Company’s common stock (the “Commitment Shares”).
−Removed: Under the Purchase Agreement, on any trading day selected by the Company, the Company has the right, in its sole discretion, to
−Removed: present Aspire Capital with a purchase notice (each, a “Purchase Notice”), directing Aspire Capital (as principal)
−Removed: to purchase up to 100,000 shares of the Company’s common stock per business day, up to $30.0 million of the Company’s
−Removed: common stock in the aggregate at a per share price (the “Purchase Price”) equal to the lesser of:
−Removed: the lowest sale price of the Company’s common stock
−Removed: on the purchase date;
−Removed: the arithmetic average of the three (3) lowest closing
−Removed: sale prices for the Company’s common stock during the ten (10) consecutive trading days ending on the trading day immediately
−Removed: preceding the purchase date.
−Removed: The Company and Aspire Capital also may
−Removed: mutually agree to increase the number of shares that may be sold to as much as an additional 2,000,000 shares per business day.
−Removed: In addition, on any date on which the Company
−Removed: submits a Purchase Notice to Aspire Capital in an amount equal to at least 100,000 shares, the Company also has the right, in its
−Removed: sole discretion, to present Aspire Capital with a volume-weighted average price purchase notice (each, a “VWAP Purchase Notice”)
−Removed: directing Aspire Capital to purchase an amount of stock equal to up to 30% of the aggregate shares of the Company’s common
−Removed: stock traded on its principal market on the next trading day (the “VWAP Purchase Date”), subject to a maximum number
−Removed: of shares the Company may determine.
−Removed: The purchase price per share pursuant to such VWAP Purchase Notice is generally 97% of the
−Removed: volume-weighted average price for the Company’s common stock traded on its principal market on the VWAP Purchase Date.
−Removed: The Purchase Price will be adjusted for
−Removed: any reorganization, recapitalization, non-cash dividend, stock split, or other similar transaction occurring during the period(s)
−Removed: used to compute the Purchase Price.
−Removed: The Company may deliver multiple Purchase Notices and VWAP Purchase Notices to Aspire Capital
−Removed: from time to time during the term of the Purchase Agreement, so long as the most recent purchase has been completed.
−Removed: The Purchase Agreement provides that the
−Removed: Company and Aspire Capital shall not effect any sales under the Purchase Agreement on any purchase date where the closing sale
−Removed: price of the Company’s common stock is less than $0.25.
−Removed: There are no trading volume requirements or restrictions under the
−Removed: Purchase Agreement, and the Company will control the timing and amount of sales of the Company’s common stock to Aspire Capital.
−Removed: Aspire Capital has no right to require any sales by the Company, but is obligated to make purchases from the Company as directed
−Removed: by the Company in accordance with the Purchase Agreement.
−Removed: There are no limitations on use of proceeds, financial or business covenants,
−Removed: restrictions on future fundings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase
−Removed: The Purchase Agreement may be terminated by the Company at any time, at its discretion, without any cost to the Company.
−Removed: Aspire Capital has agreed that neither it nor any of its agents, representatives and affiliates shall engage in any direct or indirect
−Removed: short-selling or hedging of the Company’s common stock during any time prior to the termination of the Purchase Agreement.
−Removed: Any proceeds from the Company receives under the Purchase Agreement are expected to be used for working capital and general corporate
−Removed: The Purchase Agreement provides that the
−Removed: number of shares that may be sold pursuant to the Purchase Agreement will be limited to 9,232,814 shares, including the Commitment
−Removed: Shares, or the Exchange Cap, which represents 19.99% of the Company’s outstanding shares of Common Stock as of February 28,
−Removed: 2020, unless stockholder approval is obtained to issue more than 19.99%.
−Removed: This limitation will not apply if, at any time the Exchange
−Removed: Cap is reached and at all times thereafter, the average price paid for all shares issued under the Purchase Agreement is equal
−Removed: to or greater than $2.41, which was the Closing Sale Price immediately preceding the execution of the Purchase Agreement.
−Removed: is not required or permitted to issue any shares of Common Stock under the Purchase Agreement if such issuance would breach its
−Removed: obligations under the rules or regulations of The Nasdaq Global Market.
−Removed: Concurrently with entering into the Purchase
−Removed: Agreement, the Company also entered into a registration rights agreement with Aspire Capital, pursuant to which the Company filed
−Removed: with the SEC a prospectus supplement to the Company’s effective shelf registration statement on Form S-3 (File No.
−Removed: registering all of the shares of common stock that may be offered to Aspire Capital from time to time, including the Commitment
+Added: The Company recognizes accrued interest and penalties as income tax expense.
+Added: No amounts were accrued for the payment of interest and penalties at December 31, 2020 and 2019.
+Added: The Company is currently not aware of any issues under review that could result in significant payments, accruals or material deviation from its position in the next year.
+Added: On March 27, 2020, the CARES Act was enabled in response to COVID-19 pandemic.
+Added: Under ASC 740, the effects of changes in tax rates and laws are recognized in the period which the new legislation is enacted.
+Added: The CARES Act made various tax law changes including among other things (i) increasing the limitation under Section 163(j) of the Internal Revenue Code of 1986, as amended (the “IRC”) for 2019 and 2020 to permit additional expensing of interest, (ii) enacting a technical correction so that qualified improvement property can be immediately expensed under IRC Section 168(k),(iii) making modifications to the federal net operating loss rules including permitting federal net operating losses incurred in 2018, 2019 and 2020 to be carried back to the five preceding taxable years in order to generate a refund of previously paid income taxes and (iv) enhancing the recoverability of alternative minimum tax credits.
+Added: Given the Company’s full valuation allowance position, the CARES Act did not have an impact on the financial statements.
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.