What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2023-03-22 compared with 2022-03-17 · 232 added, 176 removed, 652 unchanged (38% of the section changed)

5 unchanged sentences

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, 2022.

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, 2021 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.

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, 2022 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 Accounting Officer, to allow timely decisions regarding any required disclosure.

Management’s Report on Internal Control Over Financial Reporting

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).

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, 2021 based on the framework in Internal Control—Integrated Framework 2013 issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).

Under the supervision and with the participation of our management, including our principal executive officer and principal financial and accounting officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2022 based on the framework in Internal Control—Integrated Framework 2013 issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).

Based on that evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2022.

13 unchanged sentences

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.

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.

Our management, including our Chief Executive Officer and Chief Accounting 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.

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.

11 unchanged sentences

The information required by this item will be set forth in the section headed “Securities Authorized for Issuance Under Equity Compensation Plans” and “Security Ownership of Certain Beneficial Owners and Management” in our Proxy Statement and is incorporated herein by reference.

The information required by Item 201(d) of Regulation S-K will be set forth in the section headed “Executive Compensation "

and "Information Regarding the Board of Directors and Corporate Governance” in our Proxy Statement and is incorporated herein by reference.

The information required by Item 201(d) of Regulation S-K will be set forth in the section headed “Executive Compensation” and “Information Regarding the Board of Directors and Corporate Governance” in our Proxy Statement and is incorporated herein by reference.

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE

11 unchanged sentences

Certificate of Incorporation

Certificate of Amendment to Certificate of Incorporation of Marker Therapeutics, Inc.

Bylaws of Marker Therapeutics, Inc.

6 unchanged sentences

Registration Rights Agreement

License and Assignment Agreement, dated July 21, 2015, with The Mayo Foundation for Medical Education and Research**

License and Assignment Agreement with Mayo Foundation for Medical Education and Research dated May 19, 2016**

Incorporated by Reference

Exhibit description

Exclusive License Agreement between Baylor College of Medicine and Marker Therapeutics, Inc.

3 unchanged sentences

2009 Stock Incentive Plan*

Incorporated by Reference

Exhibit description

2014 Omnibus Stock Ownership Plan, as amended through August 29, 2017*

18 unchanged sentences

Form of Director and Officer Indemnification Agreement*

Incorporated by Reference

Exhibit description

Amendment to Employment Agreement between Marker Therapeutics, Inc.

9 unchanged sentences

Form of Common Stock Purchase Warrant

Incorporated by Reference

Exhibit description

Form of Placement Agent Warrant Common Stock Purchase Warrants-Series A

9 unchanged sentences

Form of Amended Series A-1 Warrant

Incorporated by Reference

Exhibit description

Form of Amended Series D-1 Warrant

9 unchanged sentences

Form of Private Placement Warrant

Incorporated by Reference

Exhibit description

Services Agreement, between Wilson Wolf Manufacturing

Corporation and Marker Therapeutics, Inc., effective April 12,

Purchase Agreement, by and between Marker Therapeutics, Inc.

and Lincoln Park Capital Fund, LLC, dated December 12, 2022

Registration Rights Agreement, by and between Marker

Therapeutics, Inc.

and Lincoln Park Capital Fund, LLC dated

December 12, 2022

List of Subsidiaries

7 unchanged sentences

Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002#

Incorporated by Reference

Exhibit description

XBRL Instance Document

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Chief Executive Officer (Principal Executive Officer)

/s/ Anthony Kim

Chief Financial Officer (Principal Financial and Accounting Officer)

/s/ Michael J.

Chief Accounting Officer (Principal Financial and Accounting Officer)

POWER OF ATTORNEY

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.

Each of the undersigned officers and directors of Marker Therapeutics, Inc., hereby constitutes and appoints Peter Hoang and Michael J.

Loiacono, 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.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on March 22, 2023 on behalf of the registrant and in the capacities indicated.

2 unchanged sentences

March 22, 2023

/s/ Frederick Wasserman

March 22, 2023

Frederick Wasserman

/s/ David Laskow-Pooley

5 unchanged sentences

March 22, 2023

March 17, 2022

/s/ Steve Elms

March 17, 2022

/s/ Katharine Knobil

1 unchanged sentence

Katharine Knobil

/s/ Anthony Kim

Chief Financial Officer (Principal Financial and Accounting Officer)

/s/ Steve Elms

March 22, 2023

/s/ Michael J.

Chief Accounting Officer (Principal Financial and Accounting Officer)

March 22, 2023

MARKER THERAPEUTICS, INC.

16 unchanged sentences

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern.

As more fully described in Note 2, the Company has incurred significant losses and needs to raise additional funds to sustain its operating expenses and capital expenditure requirements.

As more fully described in Note 2, the Company has incurred significant losses and needs to raise additional funds to sustain its operations.

These conditions raise substantial doubt about the Company’s ability to continue as a going concern.

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Our responsibility is to express an opinion on the Company’s financial statements based on our audits.

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.

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.

federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

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Critical Audit Matters

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:

The critical audit matters communicated below 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:

(1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.

We determined that there are no critical audit matters.

The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

Asset Impairment - Determination of Impairment Indicators on Long Lived Assets and Right-of-Use Assets - Refer to Note 3 to the Consolidated Financial Statements.

Critical Audit Matter Description

Property, plant and equipment and right-of-use assets are reviewed for impairment when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable.

As of December 31, 2022, the carrying value of the Company’s property plant and equipment was $12.3 million, and right-of-use assets $5.5 million.

We have identified the determination of impairment indicators for property, plant and equipment and right-of-use assets as a critical audit matter due to the significant judgments management makes when determining whether events or changes in circumstances have occurred indicating that the carrying amounts of an asset group may not be recoverable.

Auditing management’s judgments required a high degree of auditor judgment when performing audit procedures to evaluate whether management appropriately identified impairment indicators.

How the Critical Audit Matter Was Addressed in the Audit

Our audit procedures related to the evaluation of indicators of impairment included the following, among others:

● We evaluated the reasonableness of management’s impairment indicator analysis by performing the following procedures:

● We inquired of management whether there are change of plans and circumstances affecting the use of property, plant and equipment or assets under lease;

● We inspected minutes of the board of directors to understand if there were factors that would represent potential impairment indicators for property, plant and equipment and right-of-use assets;

● We evaluated the assumptions and the mathematical accuracy of the undiscounted cash flows used by management, for the asset recovery test.

/s/ Marcum LLP

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Accounts payable and accrued liabilities

Lease liability

Related party deferred revenue

Deferred revenue

Lease liability

Total current liabilities

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Preferred stock - $ 0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at December 31, 2022 and 2021, respectively

Common stock, $ 0.001 par value, 150 million shares authorized, 83.1 million and 50.7 million shares issued and outstanding as of December 31, 2021 and 2020, respectively

Common stock, $ 0.001 par value, 30 million and 15 million shares authorized , 8.4 million and 8.3 million shares issued and outstanding as of December 31, 2022 and 2021, respectively

Additional paid-in capital

8 unchanged sentences

For the Years Ended

Related party service revenue

Total revenues

6 unchanged sentences

( 39,477,995 )

Other income:

Change in fair value of warrant liabilities

Other income (expenses):

Arbitration settlement

12 unchanged sentences

( 356,239,484 )

Issuance common stock for cash

Warrants exercised for cash

Issuance of common stock as commitment fee for future financing

Issuance of common stock for cash (net of offering costs of $ 3.9 million)

Stock options exercised for cash

Stock-based compensation

3 unchanged sentences

( 398,118,355 )

Issuance of common stock for cash (net of offering costs of $ 3.9 million)

Stock options exercised for cash

Issuance of common shares for cash

Stock-based compensation

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Depreciation and amortization

Changes in fair value of warrant liabilities

Stock-based compensation

Amortization on right-of-use assets

Loss on disposal of fixed assets

Gain on lease termination

Changes in operating assets and liabilities:

1 unchanged sentence

Other receivables

( 2,401,767 )

Accounts payable and accrued expenses

( 4,300,939 )

Related party deferred revenue

Deferred revenue

( 1,146,186 )

Lease liability

14 unchanged sentences

Proceeds from issuance of common stock, net

Proceeds from exercise of warrants

Proceeds from exercise of stock options

Net cash provided by financing activities

Net increase (decrease) in cash, cash equivlants and restricted cash

Net (decrease) increase in cash, cash equivalents and restricted cash

( 31,715,159 )

Cash, cash equivalents and restricted cash at beginning of the year

Cash, cash equivalents and restricted cash at end of the year

Cash, cash equivalents and restricted cash at beginning of the period

Cash, cash equivalents and restricted cash at end of the period

For the Years Ended

2 unchanged sentences

Capital expenditures included in accounts payable

Issuance of common stock as commitment fee for future financing

Recognition of right-of-use assets and lease liability from new operating lease agreement

Changes to right-of-use assets and lease liability due to close out of operating leases

The accompanying notes are an integral part of these consolidated financial statements.

3 unchanged sentences

NATURE OF OPERATIONS

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.

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 for the treatment of hematological malignancies and solid tumor indications.

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.

1 unchanged sentence

The Company was incorporated in Nevada in 1992 and reincorporated in Delaware in October 2018.

Reverse Stock Split

On January 26, 2023, the Company effected a one-for-ten ( 1-for-10 ) reverse stock split of its common stock (the “Reverse Stock Split”) and a corresponding reduction in the total number of authorized shares of its common stock from 300,000,000 to 30,000,000 .

The Reverse Stock Split, which was approved by stockholders at an annual stockholder meeting on May 24, 2022, was consummated pursuant to a Certificate of Amendment filed with the Secretary of State of Delaware on January 26, 2023.

The Reverse Stock Split was effective on January 26, 2023.

All references to common stock, warrants to purchase common stock, options to purchase common stock, share data, per share data and related information contained in the consolidated financial statements have been retrospectively adjusted to reflect the effect of the Reverse Stock Split for all periods presented.

Payment for fractional shares resulting from the reverse stock split amounted to $ 394.80 .

FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS

As of December 31, 2021, the Company had cash, cash equivalents and restricted cash of approximately $ 43.5 million.

As of December 31, 2022, the Company had cash and cash equivalents of approximately $ 11.8 million.

The Company’s activities since inception have consisted principally of acquiring product and technology rights, raising capital, and performing research and development.

9 unchanged sentences

On March 16, 2021, the Company issued an aggregate of 3,228,286 shares of its common stock, for net proceeds of $ 52.6 million.

In August 2021, the Company entered into a Controlled Equity Offering SM Sales Agreement (the "ATM Agreement") with Cantor Fitzgerald & Co.

and RBC Capital Markets, LLC (the "Sales Agents"), pursuant to which the Company can offer and sell, from time to time at its sole discretion through the Sales Agents, shares of its common stock having an aggregate offering price of up to $ 75.0 million.

In August 2021, the Company entered into a Controlled Equity Offering SM Sales Agreement (the “ATM Agreement”) with Cantor Fitzgerald & Co.

and RBC Capital Markets, LLC (the “Sales Agents”), pursuant to which the Company can offer and sell, from time to time at its sole discretion through the Sales Agents, shares of its common stock having an aggregate offering price of up to $ 75.0 million.

Any shares of its common stock sold will be issued pursuant to the Company’s shelf registration statement on Form S-3 (File No.

333-258687), which the SEC declared effective on August 19, 2021;

however, our use of the shelf registration statement on Form S-3 will be limited for so long as we are subject to General Instruction I.B.6 of Form S-3, which limits the amounts that we may sell under the registration statement and in accordance with the ATM agreement.

The Sales Agents will be entitled to compensation under the Sales Agreement at a commission rate equal to 3.0 % of the gross sales price per share sold under the ATM Agreement, and the Company has provided each of the Sales Agents with indemnification and contribution rights.

To date, the Company has not sold any shares of its common stock under the ATM Agreement.

In August 2021, the Company received notice of a Product Development Research award totaling approximately $ 13.1 million from the Cancer Prevention and Research Institute of Texas ("CPRIT") to support the Company's Phase 2 clinical trial of MT-401.

During the year ended December 31, 2022, the Company sold 60,651 shares of its common stock under the ATM Agreement for net proceeds of $ 0.2 million.

In August 2021, the Company received notice of a Product Development Research award totaling approximately $ 13.1 million from the Cancer Prevention and Research Institute of Texas (“CPRIT”) to support the Company’s Phase 2 clinical trial of MT-401.

The CPRIT award is intended to support the adjuvant arm of the Company’s Phase 2 clinical trial evaluating MT-401 when given as an adjuvant therapy to patients with acute myeloid leukemia following a hematopoietic stem cell transplant.

The primary objectives of the adjuvant arm of the trial are to evaluate relapse-free survival after MT-401 treatment when compared with a randomized control group.

To date, the Company has received $ 2.4 million of funds from the CPRIT grant.

the date of this filing, the Company has received $ 4.8 million of funds from the CPRIT grant.

The Company recorded $ 3.4 million of grant income related to the CPRIT grant as revenue for the year ended December 31, 2022.

At December 31, 2021 , $ 1.1 million was recorded as Restricted Cash and Deferred Revenue on the Company’s consolidated financial statements.

On April 21, 2022, the Company entered into a binding services agreement (the “Services Agreement”), dated April 12, 2022 (see Note 9), with Wilson Wolf Manufacturing Corporation (“Wilson Wolf”).

John Wilson is a member of the Company’s board of directors and is serving as the CEO of Wilson Wolf, therefore Wilson Wolf is a related party.

Pursuant to the Services Agreement, Wilson Wolf made a cash payment to the Company in the amount of $ 8.0 million.

For the year ending December 31, 2022, the Company recognized $ 5.5 million of revenue pursuant to this agreement and at December 31, 2022, the Company recorded $ 2.5 million of related party deferred revenue on its consolidated balance sheet.

On September 13, 2022, the Company received notice from the U.S.

Food and Drug Administration (the “FDA”) that it had awarded the Company a $ 2.0 million grant from the FDA’s Orphan Products Grant program to support the Company’s Phase 2 clinical trial of MT-401 for the treatment of post-transplant AML.

The Company recorded $ 0.1 million of grant income related to the FDA grant as revenue for the year ended December 31, 2022 and at December 31, 2022, the Company recorded $ 0.1 million of grant income receivable.

On March 13, 2023, the Company received $ 0.1 million of funds from the FDA grant.

On December 12, 2022, the Company entered into a purchase agreement, or the Purchase Agreement, with Lincoln Park Capital Fund, LLC, or Lincoln Park, which provides that, upon the terms and subject to the conditions of the agreement, the Company has the right, but not the obligation, to sell to Lincoln Park up to $ 25,000,000 of shares of its common stock, or the Purchase Shares, from time to time over a 24-month term.

For the year ended December 31, 2022, the Company did not sell any shares of its common stock under the Purchase Agreement.

In January 2023, Lincoln Park was issued 180,410 shares of stock as a commitment fee at a value of $ 0.5 million.

The Company expects to continue to incur substantial losses over the next several years during its development phase.

4 unchanged sentences

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.

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, cash equivalents and restricted cash as of December 31, 2021 will enable the Company to fund its operating expenses and capital expenditure requirements into the first quarter of 2023, as such these factors raise substantial doubt regarding the Company's ability to continue as a going concern.

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, 2022 will enable the Company to fund its operating expenses and capital expenditure requirements into the third quarter of 2023, as such these factors raise substantial doubt regarding the Company’s ability to continue as a going concern.

In an effort to further preserve the Company’s working capital, the Company’s employees took a portion of their 2022 earned bonus in the form of equity in lieu of cash.

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.

9 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.

These factors raise substantial doubt regarding the Company’s ability to continue as a going concern.

These factors raise substantial doubt regarding the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued.

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.

2 unchanged sentences

However, the Company will continue to assess the effect of the pandemic on its operations, including its clinical programs.

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 emergence of any new variant strains of COVID-19, the duration and effect of business disruptions and the short-term effects and ultimate effectiveness of the travel restrictions, quarantines, social distancing requirements, the timing, distribution, rate of public acceptance and efficacy of vaccines and other treatments, and business closures in the United States and other countries to contain and treat the disease.

While the potential economic impact brought by, and the duration of the COVID-19 pandemic may be difficult to assess or predict it 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.

In addition, a recession or market correction resulting from the spread of COVID-19 and any variant strains thereof could materially affect the Company’s business and the value of its common stock.

Further, the COVID-19 pandemic, decades-high inflation and concerns about an economic recession in the United States or other major markets has resulted in, among other things, volatility in the capital markets that may have the effect of reducing the Company’s ability to access capital, which could in the future negatively affect the Company’s liquidity.

In addition, a recession or market correction due to these factors could materially affect the Company’s business and the value of its common stock.

SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America.

The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America and pursuant to the rules and regulations of the Securities Exchange Commission (“SEC”).

Any reference in these footnotes to applicable guidance is meant to refer to the authoritative U.S.

5 unchanged sentences

All significant intercompany balances and transactions are eliminated upon consolidation.

Prior Period Reclassification

Certain reclassifications have been made to reclass certain non-cash capital expenditures on the consolidated statements of cash flows from a cash outflow from investing activity to a non-cash investing activity.

The Company has evaluated the materiality of this adjustment and concluded it was not material to the previously issued consolidated financial statements and had no impact to the reported consolidated balance sheets, consolidated statements of operations or net loss per share.

For the year ended December 31, 2020, this immaterial adjustment had the effect of increasing net cash used in operating activities and decreasing net cash used in investing activities by $1.2 million from what was previously reported.

Use of Estimates

1 unchanged sentence

Accordingly, actual results could differ materially from those estimates.

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.

Significant areas requiring management’s estimates and assumptions include measurement of fair value and projections used in impairment testing, 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, Restricted Cash and Credit Risk

6 unchanged sentences

The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the balance sheets that sum to the total of the same such amounts shown in the statements of cash flows.

Cash, cash equivalents and restricted cash

Cash and cash equivalents

1 unchanged sentence

Total cash, cash equivalents and restricted cash shown in statements of cash flows

Cash received from grants in advance of incurring qualifying costs are recorded as restricted cash and deferred revenue until they are earned and recorded to grant income.

Cash received from grants in advance of incurring qualifying costs are recorded as restricted cash until they are earned and recorded to grant income.

Property and Equipment

5 unchanged sentences

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.

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.

All costs associated with the buildout were recorded as either manufacturing equipment and/or leasehold improvements and amortized over the estimated useful life of the asset and/or leasehold lease.

During the third and fourth quarters of 2021, and in connection with the Company’s manufacturing facility in Houston, Texas, the Company incurred $ 2.2 million of costs pursuant to an agreement with a vendor to build and eventually install a second modular cleanroom.

Such costs were recorded in fixed assets – construction in progress on the balance sheet as of December 31, 2021.

Upon completion and installation of the modular cleanroom, all costs associated with the buildout will be recorded as manufacturing equipment and amortized over the estimated useful life.

Fair Value Measurements

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.

Level inputs are defined as follows:

● Level 1 - Quoted prices (unadjusted) in active markets for identical assets and liabilities.

● 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.

● 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.

The Company incurred another $ 1.9 million in related costs in 2022.

Upon completion and installation of the second modular cleanroom in 2022, all costs associated with the buildout were recorded as manufacturing equipment and leasehold improvements and are being amortized over the estimated useful life.

Impairment Testing of Long-Lived Assets and Right-Of-Use Assets

Management reviews long-lived assets (including property and equipment) and right-of-use assets for assets under operating leases for impairment whenever events or changes in circumstances indicate that their carrying amount may not be recoverable.

Recoverability of assets is determined by first grouping the long-lived assets at the lowest level for which there are identifiable cash flows, and then comparing the carrying value of each asset group to its forecasted undiscounted cash flows.

If the evaluation of the forecasted cash flows indicates that the carrying value of the assets is not recoverable, an impairment charge is recognized for the amount in excess of the carrying amount over its fair value.

The Company performed a test for recoverability related to its manufacturing facility in Houston, Texas at December 31, 2022 and concluded that the carrying value of its long-lived assets was recoverable.

Patents and Patent Application Costs

6 unchanged sentences

In addition, option valuation models require the input of highly subjective assumptions, including the expected stock price volatility and expected option life:

Expected Term — The expected life of stock options was estimated using the "simplified method,"

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.

Expected Term — The expected life of stock options was estimated using the “simplified method,” 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.

The simplified method is based on the average of the vesting tranches and the contractual life of each grant.

25 unchanged sentences

No interest or penalties were recorded during the years ended December 31, 2022 and 2021.

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 Mayo Foundation for reimbursement of clinical supplies.

These payments are non-refundable and are not dependent on the Company’s ongoing future performance.

The Company has adopted a policy of recognizing these payments when received and as revenue in accordance with Accounting Standards Update No.

2014 09, "Revenue from Contracts with Customers (Topic 606)"

issued by FASB.

In August 2021, we received notice of a Product Development Research award totaling approximately $ 13.1 million from CPRIT to support our Phase 2 clinical trial of MT-401.

In accordance with ASC 730-20-25-8, the extent the financial risk associated with the research and development has been transferred to CPRIT, because repayment of the grant depends solely on the results of research and development having future economic benefit, the Company accounts for this obligation as a contract to perform research and development for others.

The funds received from CPRIT will initially be recorded as a deferred credit in the Company’s balance sheet.

Grant Income represents funding under cost reimbursement programs from government agencies and non-profit foundations for qualified research and development activities performed by the Company.

In applying the provisions of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”), the Company determined that grants and awards are out of the scope of ASC 606 because the funding entities do not meet the definition of a “customer”, as defined by ASC 606, as there is not considered to be a transfer of control of goods or services.

With respect to each grant or award, the Company determines if it has a collaboration in accordance with ASC Topic 808, Collaborative Arrangements (“ASC 808”).

To the extent the grant or award is within the scope of ASC 808, the Company recognizes the award upon achievement of certain milestones as credits to research and development expenses.

For grant and awards outside the scope of ASC 808, the Company applies ASC 606 by analogy, and revenue is recognized when the Company incurs expenses related to the grants for the amount the Company is entitled to under the provisions of the contract.

In August 2021, the Company received notice of a Product Development Research award totaling approximately $ 13.1 million from CPRIT to support its Phase 2 clinical trial of MT-401.

In accordance with ASC 730-20-25-8, to the extent the financial risk associated with the research and development has been transferred to CPRIT, because repayment of the grant depends solely on the results of research and development having future economic benefit, the Company accounts for this obligation as a contract to perform research and development for others.

Restricted cash received from grants in advance of incurring qualifying costs is recorded as deferred revenue and recognized as revenue when qualifying costs are incurred.

Qualifying grant income earned in advance of cash received from grants is recognized as revenue and recorded as other receivable.

During the fourth quarter of 2021, the Company received $ 2.4 million advancement of funds in relation to the CPRIT grant.

The Company recorded $ 3.4 million of grant income related to the CPRIT grant as revenue for the year ended December 31, 2022.

At December 31, 2021, $ 1.1 million was recorded as restricted cash and deferred revenue on the Company's consolidated financial statements.

At December 31, 2022, the Company recorded $ 2.3 million of grant income receivable, which represented grant income earned in advance of the next tranche of funds to be received from CPRIT.

In January 2023, the Company received $ 2.4 million from CPRIT.

On September 13, 2022, the Company received notice from the FDA that it had awarded the Company a $ 2.0 million grant from the FDA’s Orphan Products Grant program to support the Company’s Phase 2 clinical trial of MT-401 for the treatment of post-transplant AML.

On March 13, 2023, the Company received $ 0.1 million of funds from the FDA grant.

Loss per Common Share

4 unchanged sentences

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.

Recent Accounting Standards Adopted in the Year

In December 2019, the FASB issued ASU No.

2019-12, “Income Taxes (Topic 740):

Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes.

ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application.

This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted.

The Company has adopted the new standard effective January 1, 2021 and has concluded that the adoption of this standard did not have a material impact on its consolidated financial statements and related disclosures.

NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS

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OTHER RECEIVABLE

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.

leasehold improvements and manufacturing equipment).

In accordance with the agreement, upon completion of the facility’s construction, the Company was owed up to $ 1.0 million as reimbursement, and as such a landlord receivable was recorded, which provides for a legal right to receive construction reimbursements from the landlord for tenant improvement allowances.

During the fiscal year ended 2020, the Company recorded a $ 1.0 million receivable in its consolidated financial statements.

The Company received the $ 1.0 million reimbursement in April 2021.

Qualifying grant income earned in advance of cash received from grants is recognized as revenue and recorded as other receivable.

The Company recorded $ 3.4 million of grant income related to the CPRIT grant as revenue for the year ended December 31, 2022.

At December 31, 2022, the Company recorded $ 2.3 million of grant income receivable, which represented grant income earned in advance of the next tranche of funds to be received from CPRIT.

The Company received $ 2.4 million of funds from CPRIT in January 2023.

The Company recorded $ 0.1 million of grant income related to the FDA grant as revenue for the year ended December 31, 2022.

Additionally, at December 31, 2022, the Company recorded $ 0.1 million of grant income receivable, which represented grant income earned in advance of funds to be received from the FDA.

The Company received $ 0.1 million of funds from the FDA in January 2023.

PROPERTY AND EQUIPMENT

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( 5,274,000 )

( 2,740,000 )

Construction in progress

1 unchanged sentence

Depreciation expense for the years ended December 31, 2022 and 2021 was approximately $ 2.8 million and $ 2.1 million, respectively.

In June 2020, the Company entered into a lease for a manufacturing facility in Houston, Texas.The Company has incurred costs pursuant to an agreement with a vendor to design, engineer, build and eventually install modular cleanrooms in the manufacturing facility.

$ 6.8 million is recorded in fixed assets – construction in progress on the balance sheet as of December 31, 2020.

In June 2020, the Company entered into a lease for a manufacturing facility in Houston, Texas.

The Company incurred costs pursuant to an agreement with a vendor to design, engineer, build and eventually install modular cleanrooms in the manufacturing facility.

$ 6.8 million was recorded in fixed assets – construction in progress on the balance sheet as of December 31, 2020.

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.

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.

During January 2021, all costs associated with the buildout were recorded as either manufacturing equipment and/or leasehold improvements and amortized over the estimated useful life of the asset and/or leasehold lease.

During the year ended December 31, 2021, and in connection with the opening of the Company’s manufacturing facility in Houston, Texas, the Company incurred $ 2.2 million of costs pursuant to an agreement with a vendor to build and eventually install a second modular cleanroom.

Such costs were recorded in fixed assets – construction in progress on the balance sheet as of December 31, 2021.

The Company incurred another $ 1.9 million in related costs in 2022.

Upon completion and installation of the second modular cleanroom during the year ended December 31, 2022, all costs associated with the buildout were recorded as manufacturing equipment and leasehold improvements and amortized over the estimated useful life.

The Company leases manufacturing, research and administrative facilities under operating leases.

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Costs associated with operating leases are recognized on a straight-line basis within operating expenses over the term of the lease.

As of September 15, 2022, the Company and its landlord agreed to terminate the Company’s office lease at 3200 Southwest Freeway, Suite 2500, Houston, Texas.

As such the Company reduced its operating lease liabilities by $ 3.7 million and reduced its right-of-use

assets by $ 3.5 million.

A gain on lease termination was recorded in general and administrative expenses during the year ended December 31, 2022.

As of December 31, 2022, the Company had total operating lease liabilities of approximately $ 7.6 million and right-of-use assets of approximately $ 5.5 million, which were included in the consolidated balance sheet.

As of December 31, 2021, the Company had total operating lease liabilities of approximately $ 11.9 million and right-of-use assets of approximately $ 9.8 million, which were included in the consolidated balance sheet.

Such leases do not require any contingent rental payments, impose any financial restrictions, or contain any residual value guarantees.

1 unchanged sentence

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.

expenses generally represent the Company’s share of the landlord’s operating expenses.

Variable expenses generally represent the Company’s share of the landlord’s operating expenses.

The Company does not act as a lessor or have any leases classified as financing leases.

9 unchanged sentences

The weighted-average remaining lease term as of December 31, 2022 and December 31, 2021 was approximately 7.5 years and 8.4 years, respectively.

The weighted-average discount rate used to determine the operating lease liability as of December 31, 2021 and December 31, 2020 was approximately 5.7 %.

The weighted-average discount rate used to determine the operating lease liability as of December 31, 2022 and December 31, 2021 was approximately 5.5 % and 5.7 %, respectively.

Maturities of the Company’s operating leases, excluding short-term leases, are as follows:

Year ended December 31, 2022

Year ended December 31, 2023

Year ended December 31, 2024

Year ended December 31, 2025

Year ended December 31, 2026

Year ending December 31, 2023

Year ending December 31, 2024

Year ending December 31, 2025

Year ending December 31, 2026

Year ending December 31, 2027

Less present value discount

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Total accounts payable and accrued liabilities

In August 2022, the Company implemented changes to the Company’s organizational structure as part of an operational cost reduction plan to conserve the Company’s available capital.

In connection with these changes, the Company reduced headcount in its general and administrative function by approximately 23.5 %, including the separation of the Company’s Chief Financial Officer.

For the year ended December 31, 2022, the Company recorded $ 0.3 million of accrued compensation and benefits for severance expenses related to the operational cost reduction plan.

RELATED PARTY DEFERRED REVENUE

On April 21, 2022, the Company entered into the Services Agreement, dated April 12, 2022, with Wilson Wolf.

John Wilson is a member of the Company’s board of directors and is serving as the CEO of Wilson Wolf.

Wilson Wolf is in the business of creating products and services intended to simplify and expedite the transition of cell therapies and gene-modified cell therapies to mainstream society (the “Wilson Wolf Mission”).

Pursuant to the Services Agreement, Wilson Wolf made a cash payment to the Company in the amount of $ 8.0 million, as consideration for certain training and research services allocated as follows:

● $ 2.0 million for non-exclusive training of Wilson Wolf to make, use, and sell the Company’s cell culture non-proprietary media formulation that has been cleared in an FDA investigational new drug application;

● $ 1.0 million for non-exclusive training of Wilson Wolf to replicate the Company’s quality management system inclusive of all underlying documents related thereto, none of which shall include unique information specific to the manufacture of the Company’s multiTAA product candidates such as direct peptide stimulation;

● $ 2.0 million for non-exclusive training of Wilson Wolf to be able to replicate the Company’s cGMP-compliant, linearly scalable, G-Rex based T-cell manufacturing process which Wilson Wolf shall use as it sees fit in pursuit of the Wilson Wolf Mission;

● $ 3.0 million for the Company to train Wilson Wolf on its expertise in the optimization of T-cell therapy manufacturing processes using G-Rex and to conduct CAR T and TCR G-Rex Optimization Work under the direction of Wilson Wolf (the “Work Direction”), whereunder all intellectual property provided by Wilson Wolf or created or derived by the Company will be solely owned by Wilson Wolf, and whereby the Company will make good faith efforts to complete the conduct of such work as soon as practicable within 18 months from the date of the agreement.

Wilson Wolf has agreed to pay the Company an additional $ 1.0 million if the Work Direction is completed within one year from the onset of the Agreement.

Pursuant to the Services Agreement, in the event that the Company becomes insolvent, goes out of business, or an event other than force majeure occurs that cannot allow the Agreement to be fulfilled, Wilson Wolf will have right of first offer and right of first refusal for the Company’s manufacturing facility provided it is able and willing to meet whatever financial obligations are required to do so and provided further that such clause will not apply in the event of a merger, reorganization or consolidation of the Company with a third party that results in the outstanding voting securities of the Company immediately prior thereto ceasing to represent, or being converted into or exchanged for voting securities that do not represent, at least fifty percent ( 50 %) of the combined voting power of the voting securities of the surviving entity or the parent corporation of the surviving entity immediately after such merger, reorganization or

consolidation, or the sale or other transfer of all or substantially all of the Company’s business or assets.

The Company agrees to assist as needed to the extent permitted under any applicable law (including bankruptcy or insolvency statutes).

Further, prior to the Company undertaking any financing that would encumber any of the Company’s assets necessary for the Company’s performance under this Services Agreement, Wilson Wolf shall have the first right to provide such financing on equal terms to what the Company can obtain elsewhere.

The Company recognizes related party revenue over time in accordance with Accounting Standard Codification, or ASC, 606 Revenue from Contracts with Customers, as each of the training or and research services are provided to Wilson Wolf.

Revenue is recognized, using an output method based on progress toward satisfaction of the performance obligations.

Additionally, in accordance the spirit of the standard expressed in ASC 606-50-1, the timing of the revenue recognition is expected to be approximately 12 months.

For the year ending December 31, 2022, the Company recognized $ 5.5 million of revenue pursuant to the Services Agreement and at December 31, 2022, the Company recorded an $ 2.5 million related party deferred revenue on its consolidated balance sheet.

STOCKHOLDERS’ EQUITY

Increase in Authorized Shares

During the three months ended June 30, 2022, the Company’s board of directors and stockholders approved a Certificate of Amendment (the “Amendment”) to the Company’s Certificate of Incorporation to increase the authorized shares of common stock of the Company from 15,000,000 shares to 30,000,000 shares.

The Company filed the Amendment with the Secretary of State of Delaware on May 25, 2022.

Reverse Stock Split

On January 26, 2023, the Company effected the Reverse Stock Split and a corresponding reduction in the total number of authorized shares of its common stock from 300,000,000 to 30,000,000 .

The Reverse Stock Split, which was approved by stockholders at an annual stockholder meeting on May 24, 2023, was consummated pursuant to a Certificate of Amendment filed with the Secretary of State of Delaware on January 26, 2023.

The Reverse Stock Split was effective on January 26, 2023.

All historical share and per share amounts reflected in this report have been adjusted to reflect the Reverse Stock Split.

Preferred Stock

5 unchanged sentences

2022 Common Stock Transactions

Issuance of Restricted Stock Units to Executives

During the year ended December 31, 2022, upon the recommendation of the compensation committee of the Company’s board of directors, and pursuant to the Company’s 2020 Equity Incentive Plan, the Company’s board of directors approved the issuance of a total of 37,252 shares of common stock, valued at a total of approximately $ 180,200 , subject to restricted stock units, which were immediately vested upon grant, to certain executives as performance bonuses for performance during the year ended December 31, 2021.

Issuance of Stock Pursuant to ATM Agreement

During the year ended December 31, 2022, the Company issued and sold 60,651 shares of its common stock under the ATM Agreement for net proceeds of $ 202,100 .

Stock Purchase Agreement

On December 12, 2022, we entered into a purchase agreement, or the Purchase Agreement, with Lincoln Park Capital Fund, LLC, or Lincoln Park, which provides that, upon the terms and subject to the conditions of the agreement, we have the right, but not the obligation, to sell to Lincoln Park up to $ 25,000,000 of shares of our common stock, or the Purchase Shares, from time to time over a 24-month term , at a variable price with certain market-based terms as defined in the agreement.

The purchase agreement does not exhibit any of the characteristics for liability classification under ASC Topic 480, Distinguishing Liabilities from Equity.

Instead, the purchase agreement is indexed to the Company’s own stock under ASC Subtopic 815-40, Contracts in Entity's Own Equity, and classified as equity.

During the year ended December 31, 2022, we did not sell any shares of our stock under the Purchase Agreement.

In January 2023, Lincoln Park was issued 180,410 shares of stock as a commitment fee at a value of $ 0.5 million.

2021 Common Stock Transactions

Exercise of Stock Options

1 unchanged sentence

Board Compensation

During the year ended December 31, 2021, the Company issued an aggregate of 0.1 million shares of common stock to its non-employee directors.

During the year ended December 31, 2021, the Company issued an aggregate of 6,329 shares of common stock to its non-employee directors.

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.

3 unchanged sentences

In addition, the Company granted the underwriters an option to purchase, for a period of 30 days , up to an additional 428,580 shares of common stock, which such option was partially exercised with respect to 371,086 shares.

An aggregate of 32,282,857 shares of the Company’s common stock was issued for net proceeds of $ 52.6 million.

2020 Common Stock Transactions

Exercise of Stock Warrants

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

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.

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.

Aspire Capital

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.

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.

The Company recorded the commitment fee to additional paid in capital.

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.

Aspire Capital did not purchase any shares under the Purchase Agreement during the year ended December 31, 2021.

An aggregate of 3,228,286 shares of the Company’s common stock was issued for net proceeds of $ 52.6 million after offering costs of $ 3.9 million.

Share Purchase Warrants

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Balance - January 1, 2021

Exercised for cash

Expired or cancelled

( 1,376,000 )

Balance - December 31, 2021

Expired or cancelled

( 1,000,000 )

Balance - December 31, 2022

2020 Warrant Transactions

Exercise of Stock Warrants

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.

STOCK OPTION PLANS

Options to Purchase Shares of Common Stock

2021 Equity Incentive Awards

On May 19, 2020, the Board adopted the 2020 Equity Incentive Plan ("2020 Plan") which replaced the 2014 Omnibus Stock Option Plan.

The 2020 Plan was further amended effective May 2022 to increase the number of shares of common stock authorized for issuance under the plan by 850,000 shares.

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.

2 unchanged sentences

Options granted under the 2020 Plan have a maximum term of ten years from the date of grant and generally vest over four years .

On February 10, 2021, pursuant to the Company's 2020 Equity Incentive Plan, the compensation committee of the Company's board of directors approved a total of 740,000 options to purchase the Company's common stock as equity-based incentive awards to the Company's executive officers, other than the Chief Executive Officer.

2022 Equity Incentive Awards

On February 17, 2022, pursuant to the Company’s 2020 Equity Incentive Plan, the compensation committee of the Company’s board of directors approved a total of 125,000 options to purchase the Company’s common stock as equity-based incentive awards to the Company’s executive officers.

Each option award was granted with an exercise price of $ 4.60 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on February 17, 2022, with the option award vesting in 48 equal monthly installments over a four-year period, subject to such executive officer’s continued service on the applicable vesting date.

Additionally, on February 17, 2022, the compensation committee of the Company’s board of directors approved a total of 39,500 options to purchase the Company’s common stock to non-executive employees of the Company as equity-based incentive awards.

Each option award was granted with an exercise price of $ 3.29 per share, the closing price of the Company's common stock on

the Nasdaq Global Market on February 10, 2021, with the option award vesting in 48 equal monthly installments over a four-year period, subject to such employee's continued service on the applicable vesting date.

On February 11, 2021, upon the recommendation of the compensation committee and pursuant to the Company's 2020 Equity Incentive Plan, the Company's board of directors approved a total of 430,000 options to purchase the Company's common stock as (equity-based incentive awards to the Company's Chief Executive Officer.

The option award was granted with an exercise price of $ 3.06 per share, the closing price of the Company's common stock on the Nasdaq Global Market on February 11, 2021, with the option award vesting in 48 equal monthly installments over a four-year period, subject to such Chief Executive Officer's continued service on the applicable vesting date.

Each option award was granted with an exercise price of $ 4.60 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on February 17, 2022, with the option award vesting in 48 equal monthly installments over a four-year period, subject to such employee’s continued service on the applicable vesting date.

The above awards were in addition to 17,500 stock option awards issued during the three months ended March 31, 2022 to new employees upon their commencement of employment with the Company.

4 unchanged sentences

Each option award was granted with an exercise price of $ 3.50 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on July 1, 2022, with 25 % of the option award vesting in one year and the remaining 75 % vesting in 36 equal monthly installments thereafter over a three-year period, subject to such employee’s continued service on the applicable vesting date.

40,000 stock option awards were issued during the three months ended December 31, 2021 to new employees upon their commencement of employment with the Company.

Additionally, 7,000 stock option awards were issued during the three months ended December 31, 2022 to new employees upon their commencement of employment with the Company.

Each option award was granted with an exercise price of $ 3.73 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on October 3, 2022, with 25 % of the option award vesting in one year and the remaining 75 % vesting in 36 equal monthly installments thereafter over a three-year period, subject to such employee’s continued service on the applicable vesting date.

Also, 125,000 stock option awards were issued to a new outside director.

The option award was granted with an exercise price of $ 1.20 per share, the closing price of the Company's common stock on the Nasdaq Global Market on December 8, 2021, vesting in 36 equal monthly installments.

During the year ended December 31, 2021, 1,456 stock options were exercised for net proceeds of $ 3,100 .

As of December 31, 2021, approximately 2.9 million options are available to be issued from the 2020 Plan.

Also, pursuant to the Company’s Non-Employee Director Compensation Policy, which had previously been approved by the Company’s board of directors, 40,000 stock option awards were issued during the year ended December 31, 2022 to independent members of the board of directors of the Company.

Each option award was granted on May 24, 2022 with an exercise price of $ 3.377 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on May 24, 2022.

Each option award will vest in one year subject to the director’s continuance of service through May 24, 2023.

As of December 31, 2022, approximately 989,000 shares of common stock are available to be issued under the 2020 Plan.

Stock Options

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Weighted Average

Total Intrinsic

Number of Shares

Exercise Price

Total Intrinsic Value

Life (in years)

2 unchanged sentences

Outstanding as of December 31, 2021

Canceled/Expired

Outstanding as of December 31, 2022

Options vested and exercisable

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Future option grants will impact the compensation expense recognized.

During the years ended December 31, 2021 and 2020, the Company received $ 0 and $ 0.5 million, respectively, of a grant awarded to Mayo Foundation from the U.S.

Department of Defense for the Phase 2 Clinical Trial of TPIV200.

The grant compensated the Company for clinical supplies manufactured and provided by the Company for the clinical study.

Additionally, in August 2021, the Company received notice of a Product Development Research award totaling approximately $ 13.1 million from CPRIT to support the Company's Phase 2 clinical trial of MT-401.

In August 2021, the Company received notice of a Product Development Research award totaling approximately $ 13.1 million from CPRIT to support the Company’s Phase 2 clinical trial of MT-401.

The primary objectives of the adjuvant arm of the trial are to evaluate relapse-free survival after MT-401 treatment when compared with a randomized control group.

During the fourth quarter of 2021, the Company received $ 2.4 million advancement of funds in relation to the CPRIT grant.

The Company recorded $ 1.2 million of grant income related to the CPRIT grant as revenue for the year ended December 31, 2021.

At December 31, 2021 $ 1.1 million was recorded as Restricted Cash and Deferred Revenue on the Company's consolidated financial statements.

Restricted cash received from grants in advance of incurring qualifying costs is recorded as deferred revenue and recognized as revenue when qualifying costs are incurred.

Qualifying grant income earned in advance of cash received from grants is recognized as revenue and recorded as other receivable.

The Company recorded $3.4 million and $ 1.2 million of grant income related to the CPRIT grant as revenue for the years ended December 31, 2022 and 2021, respectively.

At December 31, 2022, the Company recorded $ 2.3 million of grant income receivable, which represented grant income earned in advance of the next tranche of funds to be received from CPRIT.

In January 2023, the Company received $ 2.4 million from CPRIT.

On March 13, 2023, the Company received $ 0.1 million of funds from the FDA grant.

LEGAL PROCEEDINGS

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The FINRA panel found in favor of the broker and awarded the broker $ 2.4 million for compensation, interest and attorney fees.

As of September 30, 2021, the Company recorded an accrual of $ 2.4 million in accrued liabilities on its consolidated balance sheet and a $ 2.4 million charge to other expenses.

As of December 31, 2021, the Company recorded an accrual of $ 2.4 million in accrued liabilities on its consolidated balance sheet and a $ 2.4 million charge to other expenses.

On September 17, 2021, the broker filed a petition to confirm the FINRA arbitration award in the Supreme Court of New York for the County of New York.

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On March 9, 2022, the Company was notified that its motion to vacate the award was denied and the broker was awarded an additional $ 0.1 million in interest.

Post judgment interest will continue to accrue at 1.02 % until the judgement is paid.

Post judgment interest accrued at 1.02 % until the judgment was paid.

On March 24, 2022, the Company paid the broker $ 2.5 million, which amount included accrued interest.

On January 4, 2023, the Company was notified that the broker was awarded an additional $ 0.1 million in attorneys’ fees, which the Company recorded to other expenses during fiscal year ending December 31, 2022.

The Company paid the $ 0.1 million on January 9, 2023.

RELATED PARTY TRANSACTIONS

5 unchanged sentences

Total Research and development

$ 1.0 million of related party transactions are included in accounts payable and accrued liabilities as of December 31, 2021.

$8,600 of related party transactions are included in accounts payable and accrued liabilities as of December 31, 2022.

Agreements with The Baylor College of Medicine (“BCM”) .

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The Company is currently utilizing Bio-Techne Corporation and two of its brands for the purchases of reagents, primarily cytokines.

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.

Purchases from Wilson Wolf Manufacturing Corporation .

The Company is currently utilizing Wilson Wolf Manufacturing Corporation for the purchases of cell culture devices called G-Rexes.

David Eansor is a member of the Company’s board of directors and was serving as the President of the Protein Sciences Segment of Bio-Techne Corporation.

Eansor resigned from Bio-Techne Corporation on March 1, 2022, and as such, two months of transactions in 2022 are included in the table above.

Purchases from Wilson Wolf .

The Company is currently utilizing Wilson Wolf for the purchases of cell culture devices called G-Rexes.

John Wilson is a member of the Company’s board of directors and is serving as the CEO of Wilson Wolf Manufacturing Corporation.

Wilson Wolf Manufacturing became a related party during fiscal year 2021 and as such, $ 61,000 transactions for the period ended December 31, 2020 were included in the table above.

The Company has no income tax expense due to operating losses incurred for the years ended December 31, 2022 and 2021.

The effects of temporary differences that give rise to significant portions of the deferred tax assets as of December 31, 2022 and 2021 are as follows:

As of December 31,

For the Years Ended

Deferred Tax Assets

(As reported)

Net Operating Loss Carryforward

1 unchanged sentence

Accrued Expenses

License Agreements

License Agreement

Capitalized R&E

Research and Development

4 unchanged sentences

( 36,401,000 )

( 29,689,000 )

Total Deferred Tax Assets

3 unchanged sentences

( 2,083,000 )

( 2,380,000 )

Total Deferred Tax Liabilities

1 unchanged sentence

( 2,177,000 )

( 2,380,000 )

Net Deferred Tax Assets/(Liabilities)

2 unchanged sentences

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, 2022 and 2021.

The Company decreased the prior period deferred tax asset by $ 2.1 million with a corresponding decrease in its valuation allowance.

This immaterial adjustment mostly related to the correction of the cumulative value of cancelled non-qualified stock options.

The Company has research and development tax credit carryforwards of $ 733,000 available to offset future federal income taxes.

3 unchanged sentences

The federal net operating loss carryforwards of $ 93.6 million generated in 2018 and thereafter are subject to an 80 % limitation on taxable income, do not expire and will carry forward indefinitely.

The state net operating loss carryforwards of

$ 21.9 million, if not utilized, will begin to expire in 2035.

The state net operating loss carryforwards of $ 21.9 million, if not utilized, will begin to expire in 2035.

The state net operating loss carryforwards of $ 16.6 million generated in 2018 and thereafter are subject to an 80 % limitation on taxable income, do not expire and will carry forward indefinitely.

1 unchanged sentence

A full Section 382 analysis has not been prepared and NOLs could be subject to limitation under Section 382.

Effective for tax years beginning after December 31, 2021, taxpayers are required to capitalize any expenses incurred that are considered incidental to research and experimentation (R&E) activities under IRC Section 174.

While taxpayers historically had the option of deducting these expenses under IRC Section 174, the December 2017 Tax Cuts and Jobs Act mandates capitalization and amortization of R&E expenses for tax years beginning after December 31, 2021.

Expenses incurred in connection with R&E activities in the US must be amortized over a 5-year period if incurred, and R&E expenses incurred outside the US must be amortized over a 15-year period.

R&E activities are broader in scope than qualified research activities considered under IRC Section 41 (relating to the research tax credit).

For the year ended December 31, 2022, the Company performed an analysis based on available guidance and determined that it will continue to be in a loss position even after the required capitalization and amortization of its R&E expenses.

The Company will

continue to monitor this issue for future developments, but it does not expect R&E capitalization and amortization to require it to pay cash taxes now or in the near future.

The Company’s income tax returns for 2018 to 2021 are still open and subject to audit.

9 unchanged sentences

Permanent Differences

- Change in fair value of derivative liabilities

- Other permanent differences

8 unchanged sentences

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.

On March 27, 2020, the CARES Act was enabled in response to COVID-19 pandemic.

Under ASC 740, the effects of changes in tax rates and laws are recognized in the period which the new legislation is enacted.

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.

Given the Company’s full valuation allowance position, the CARES Act did not have an impact on the financial statements.

SUBSEQUENT EVENTS

On February 16, 2022, the Company received a notice from the Nasdaq Global Market that the Company was not in compliance with Nasdaq's Listing Rule 5450(a)(1), as the minimum bid price of its common stock had been below $ 1.00 per share for 30 consecutive business days.

The Company has 180 calendar days, or until August 15, 2022, to regain compliance with the minimum bid price requirement.

To regain compliance, the minimum bid price of the Company's common stock must meet or exceed $ 1.00 per share for a minimum of ten consecutive business days during this 180 -calendar day grace period.

In the event the Company does not regain compliance with the minimum bid price requirement by August 15, 2022, the Company may be eligible for an additional 180 -calendar day compliance period if it elects to transfer to the Nasdaq Capital Market to take advantage of the additional compliance period offered on that market.

To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the bid price requirement, and would need to provide written notice of its intention to cure the bid price deficiency during the second compliance period.

On March 13, 2023, Mythili Koneru, Chief Medical Officer of Marker Therapeutics, Inc., notified the Company of her intent to resign as Chief Medical Officer of the Company effective as of April 9, 2023.

On March 14, 2023, the Company signed an agreement with AlloVir, Inc.

in which Marker will collaborate with AlloVir to optimize certain aspects of AlloVir’s manufacturing process.

Under the terms of this agreement, Marker will conduct a number of process improvement studies and provide AlloVir with the results of its findings.

For its work with AlloVir, the Company will receive total compensation in the amount of $ 400,000 , estimated to be fully earned by the end of the third quarter in 2023.

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.

What changed 10-K

Item 9A. Controls and Procedures