What changed in this filing

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Item 9A. Controls and Procedures

2025-03-31 compared with 2024-03-26 · 247 added, 262 removed, 611 unchanged (45% of the section changed)

27 unchanged sentences

OTHER INFORMATION

(a) The information set forth below is provided in lieu of a separate Form 8-K filing.

On March 27, 2025, we mutually agreed with Cell Ready to terminate the MSA.

In connection therewith, we entered into a settlement and release agreement with Cell Ready pursuant to which we paid Cell Ready approximately $453,000 and we provided one another with mutual releases of all claims associated with any and all agreements between Marker and Cell Ready.

Rule 10b5–1 trading arrangement.

During the fourth quarter of 2023, no director or Section 16 officer adopted or terminated any Rule 10b5-1 plan or non-Rule 10b5-1 trading arrangements.

During the fourth quarter of 2024, n o director or Section 16 officer adopted or terminated any Rule 10b5-1 plan or non-Rule 10b5-1 trading arrangements.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

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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.

We also have adopted an insider trading policy governing the purchase, sale, and/or other dispositions of our securities by directors, officers and employees that are reasonably designed to promote compliance with insider trading laws, rules and regulations, and any listing standards applicable to the registrant.

A copy of our insider trading policy is filed as an exhibit to this Annual Report on Form 10-K.

In addition, from time to time, we may engage in transactions in our company’s securities.

It is our intent to comply with applicable laws and regulations relating to insider trading.

EXECUTIVE COMPENSATION

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EXHIBITS, FINANCIAL STATEMENT SCHEDULES

(a) The documents filed as part of this report are as follows:

The documents filed as part of this report are as follows:

The financial statements and accompanying report of independent registered public accounting firm are set forth immediately following the signature page of this report beginning on page F-1.

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Description of Securities of Marker Therapeutics, Inc.

Form of Pre-Funded Warrant

Form of Series A Warrant (Private Placement Warrant)

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

2 unchanged sentences

dated November 16, 2018***

Consulting Agreement between Dr.

Juan Vera and Marker Therapeutics, Inc.

dated October 19, 2018*

Form of Director and Officer Indemnification Agreement*

3 unchanged sentences

2020 Equity Incentive Plan.

Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Award Agreement under the Marker Therapeutics, Inc.

2020 Equity Incentive Plan.

Incorporated by Reference

Exhibit description

Securities Purchase Agreement dated December 19, 2024

Registration Rights dated December 19, 2024

At The Market Offering Agreement, dated as of November 27, 2024, between the Company and H.C.

Wainwright & Co., LLC

Master Services Agreement for Product Supply between Marker Therapeutics, Inc.

and Cell Ready LLC dated February 22, 2024**

Work Order #1 between Marker Therapeutics, Inc.

and Cell Ready LLC dated February 22, 2024**

Controlled Equity Offering Sales Agreement, dated as of August 10, 2021, by and among Marker Therapeutics, Inc.

and Cantor Fitzgerald & Co.

and RBC Capital Markets, LLC

Insider Trading Policy

Incorporated by Reference

Exhibit description

List of Subsidiaries

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These certifications are being furnished solely to accompany this annual report pursuant to 18 U.S.C.

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.

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

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March 31, 2025

/s/ John Wilson

March 25, 2024

/s/ Katharine Knobil

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In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.

Explanatory Paragraph – Going Concern

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 meet its obligations and sustain its operations.

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

Management's plans in regard to these matters are also described in Note 2.

The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

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We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matter Description

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:

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:

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

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.

Discontinued Operations – Recognition and deconsolidation of assets sold to a related party.

Critical Audit Matter Description

The Company evaluates the classification of assets and liabilities in connection with any disposition of significant assets to determine the appropriate financial statement recognition.

We identified the sale of a significant portion of the Company’s operations comprising a majority of its net assets in a sale to a related party as a critical audit matter due to the related party nature of the transaction and the significance of the disposition resulting in a strategic shift in the Company’s business activities.

The accounting for the disposition of net assets included in consolidated net assets requires auditor judgment when performing audit procedures to evaluate whether management appropriately recognized the classification of net assets sold and revenues and costs associated with discontinued operations and the calculation of gain or loss on sale to a related party.

How the Critical Audit Matter Was Addressed in the Audit

Our audit procedures related to the evaluation of the sale of certain operations to a related party, Cell Ready, LLC, included the following, among others:

● We evaluated management’s assessment of the transaction:

● As the sale of an asset or business;

● To determine gain or loss recognition;

● To determine classification of items between continuing and discontinued operations;

● To determine accounting for transaction costs;

● Testing of completeness and accuracy of deconsolidation of net assets.

● We inspected Board of Director’s minutes for authorization of the transaction.

● We evaluated management’s assessment of the business purpose of the transaction in connection with our review of related party transactions.

● We examined the transaction documents to ensure the Company recognized and disclosed all significant transaction terms.

● We examined key employee agreements, including modifications to employee stock options, in connection with the sale for recognition and disclosure.

We determined that there are no critical audit matters.

/s/ Marcum LLP

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Other receivables

Current assets of discontinued operations

Total current assets

Non-current assets of discontinued operations

LIABILITIES AND STOCKHOLDERS’ EQUITY

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Related party payable

Current liabilities of discontinued operations

Total current liabilities

Non-current liabilities of discontinued operations

Total liabilities

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Total liabilities and stockholders’ equity

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

All historical share and per share amounts reflected in this report have been adjusted to reflect the reverse stock split.

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

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Other income (expenses):

Arbitration settlement

Interest income

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( 2,922,406 )

( 10,154,779 )

Gain on disposal of discontinued operations, net of $ 63,000 in tax

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( 8,236,814 )

( 29,930,694 )

Net earnings (loss) per share:

Loss from continuing operations, basic and diluted

Income (loss) from discontinued operations, basic and diluted

Income from discontinued operations, basic and diluted

Net loss per share, basic and diluted

Weighted average number of common shares outstanding:

On January 26, 2023, the Company effected a one-for-ten ( 1-for-10 ) reverse stock split of its common stock.

All historical share and per share amounts reflected in this report have been adjusted to reflect the reverse stock split.

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

4 unchanged sentences

( 428,049,049 )

Issuance of common shares for cash, net

Shares issued pursuant to ATM and Lincoln Park agreements

Issuance of common stock as commitment fee

Issuance of common stock from exercise of stock options

Stock-based compensation

1 unchanged sentence

( 8,236,814 )

Fractional shares adjustment due to reverse split

Balance at December 31, 2023

( 436,285,863 )

Shares issued pursuant to ATM and Lincoln Park agreements

Issuance of common stock as commitment fee

Shares purchased pursuant to ATM agreement

Issuance of common stock from exercise of stock options

Issuance of common stock, prefunded warrants and warrants for cash, net of offering costs of $ 1.2 million

Stock-based compensation

1 unchanged sentence

( 10,731,315 )

Fractional shares adjustment due to reverse split

Balance at December 31, 2024

( 447,017,178 )

On January 26, 2023, the Company effected a one-for-ten ( 1-for-10 ) reverse stock split of its common stock.

All historical share and per share amounts reflected in this report have been adjusted to reflect the reverse stock split.

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

5 unchanged sentences

( 8,236,814 )

gain (loss) from discontinued operations, net of $ 63,000 in tax

( 10,154,779 )

gain from discontinued operations, net of $ 63,000 in tax

Net loss from continuing operations

3 unchanged sentences

Stock-based compensation

Gain on lease termination

Changes in operating assets and liabilities:

2 unchanged sentences

( 1,318,888 )

Related party payable

Accounts payable and accrued expenses

( 1,319,710 )

Deferred revenue

( 1,146,186 )

Net cash used in operating activities - continuing operations

3 unchanged sentences

( 6,098,899 )

( 5,458,675 )

Net cash used in operating activities

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Cash Flows from Investing Activities:

Net cash provided by (used in) investing activities - discontinued operations

( 4,945,136 )

Net cash provided by (used in) investing activities

( 4,945,136 )

Net cash provided by investing activities - discontinued operations

Net cash provided by investing activities

Cash Flows from Financing Activities:

Proceeds from issuance of common stock, net

Proceeds from issuance of common stock, prefunded warrants and warrants, net

Proceeds from stock options exercise

Net cash provided by financing activities

Net increase (decrease) in cash and cash equivalents

( 31,715,159 )

Net increase in cash and cash equivalents

Cash and cash equivalents at beginning of the year

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Supplemental schedule of non-cash financing and investing activities:

Capital expenditures in accounts payable

Issuance of common stock as commitment fee for future financing

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

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

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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.

The Company’s multi antigen recognizing (“MAR”)-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.

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Purchase Agreement with Cell Ready;

Manufacturing

On June 26, 2023, the Company completed the previously announced transaction with Cell Ready, LLC (“Cell Ready”) pursuant to a Purchase Agreement (the “Cell Ready Purchase Agreement), dated May 1, 2023, by and between the Company and Cell Ready.

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

John Wilson was a member of the Company’s board of directors at the time of the Cell Ready Purchase Agreement and through December 31, 2024 and is serving as the CEO of Cell Ready, therefore Cell Ready is a related party.

Wilson resigned as a director of the Company on January 24, 2025.

Pursuant to the Cell Ready Purchase Agreement, effective as of the Closing Date, the Company (i) assigned to Cell Ready the leases for the Company’s two manufacturing facilities in Houston, Texas (the “Manufacturing Facilities”), (ii) sold to Cell Ready all of the equipment and leasehold improvements at the Manufacturing Facilities and (iii) assigned to Cell Ready its rights, title and interest in the Company’s Master Services Agreement for Product Supply (the “MSA”), dated April 7, 2023, by and between the Company, Cell Ready and Indapta Therapeutics, Inc., as well as its rights, title and interest in any contracts related to the equipment and Manufacturing Facilities (collectively, the “Purchased Assets”).

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Based upon the magnitude of the disposition and because the Company is exiting certain manufacturing operations, the disposition represents a significant strategic shift that will have a material effect on the Company’s operations and financial results.

Accordingly, the assets sold meet the definition of a discontinued operation, as defined by Accounting Standards Codification (“ASC”) 205-20 - Discontinued Operations, and prior comparative periods have been retroactively adjusted to reflect the current presentation.

Accordingly, the assets sold meet the definition of a discontinued operation, as defined by Accounting Standards Codification (“ASC”) 205-20 - Discontinued Operations.

See additional discussion at Note 6.

On February 22, 2024, we entered into a Master Services Agreement for Product Supply (the “MSA”) with Cell Ready to provide outsourced services previously performed by the Company prior to its asset sale to Cell Ready.

Cell Ready, which is owned by one of our directors and shareholders, Mr.

John Wilson, is a contract development and manufacturing organization (CDMO).

Under the MSA, it is anticipated Cell Ready will perform a wide variety of services for us, including research and development, and manufacturing in support of our clinical trials.

Pursuant to the MSA, the Company may contract with Cell Ready for the provision of various products and services from time to time by entering into work orders with Cell Ready.

If the services involve the supply of product, Cell Ready is required to supply such product in conformance with the product requirements set forth in the applicable work order(s).

Under the MSA, Cell Ready is to use only personnel with sufficient qualifications and experience to supply the services contemplated by the MSA, provide its personnel with adequate training and assume full responsibility for its personnel’s compliance with the MSA.

Further, Cell Ready is required to provide the Company with assistance and cooperation in order for the Company to obtain and maintain all necessary regulatory approvals, at the Company’s expense.

Following the closing of the Cell Ready Purchase Agreement, the Company no longer operates a cGMP manufacturing facility and instead relies on third parties for the clinical and, once approved, commercial manufacture of our product candidates.

As such, on February 22, 2024, the Company entered into a Master Services Agreement for Product Supply (the “MSA”) with Cell Ready for the provision of various products and services by Cell Ready pursuant to work orders that may be entered into from time to time.

Cell Ready is a contract development and manufacturing organization (CDMO).

The MSA contains customary representations, warranties and indemnification provision.

The initial term of the MSA is three years and may be extended upon the mutual written agreement of the parties.

Either party may terminate the MSA (a) for material breach by the other party if such breach has not been cured within 30 days following notice of termination or (b) if the other party is the subject of an insolvency event.

Additionally, the Baylor College of Medicine (“BCM”) continues to supply the Company with products and the Company is working with both of its existing qualified contract manufacturers as it continues its clinical trials.

Furthermore, in anticipation of the commencement of the Company’s larger pivotal trial for Lymphoma in 2026, as well as the eventual need for commercial scale production, the Company intends to evaluate and qualify additional potential third-party manufacturing partners to provide potential multiple sources of clinical and commercial supply.

However, there is no guarantee that the Company will or has properly estimated its required manufacturing capacities or that the third parties on which it relies to manufacture products will be able or willing to perform on proposed timelines or to meet the Company’s manufacturing demands, if at all.

If any third-party vendors experience disruptions or otherwise cease or substantially reduce the amount of products they are willing to supply, the Company’s business and operations could be adversely affected.

Organizational Changes

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Vera was appointed as the Company’s Principal Financial and Accounting Officer.

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.

FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS

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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 we have provided each of the Sales Agents with indemnification and contribution rights.

and RBC Capital Markets, LLC (the “Sales Agents”), pursuant to which the Company could 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 were 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 was limited for so long as we were subject to General Instruction I.B.6 of Form S-3, which limited the amounts that we could sell under the registration statement and in accordance with the ATM agreement.

The Sales Agents were 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 we provided each of the Sales Agents with indemnification and contribution rights.

During the year ended December 31, 2024, the Company sold 8,178 shares of its common stock under the ATM Agreement for proceeds of $ 0.04 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.

the date of this filing, the Company has received $ 6.8 million of funds from the CPRIT grant.

The Company recorded $ 2.7 million of grant income related to the CPRIT grant as revenue for the year ended December 31, 2023.

In September 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 $ 0.4 million and $ 0.1 million of grant income related to the FDA grant as revenue for the year ended December 31, 2023 and December 31, 2022, respectively.

As of December 31, 2023, the Company recorded $ 0.3 million of grant income receivable.

In February 2024, the Company received $ 0.3 million of funds from the FDA grant.

In May 2023, the Company received notice of a $ 2.0 million grant from the National Institutes of Health Small Business Innovation Research program to support the development and investigation of MT-401 for the treatment of AML patients following standard-of-care therapy with hypomethylating agents.

The Company recorded $ 0.2 million of grant income related to the SBIR grant as revenue for the year ended December 31, 2023.

As of December 31, 2023, the Company recorded $ 0.2 million as other receivable, which represented grant income earned in advance of funds to be received from the SBIR.

On June 10, 2024, the Company provided notice of its termination of the ATM Agreement with Cantor Fitzgerald & Co.

and RBC Capital Markets, LLC.

The Company is not subject to any termination penalties related to the termination of the ATM Agreement.

In November 2024, the Company entered into an At The Market Offering Agreement, or the Sales Agreement, with H.C.

Wainwright & Co.

LLC, relating to the sale of shares of its common stock having an agreement offering price of up to $ 11,431,713 from time to time through H.C.

Wainwright & Co.

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

333-283512), which the SEC declared effective on December 6, 2024.

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

Wainwright & Co.

LLC 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 H.C.

Wainwright & Co.

LLC with indemnification and contribution rights.

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

Through the date of this filing, the Company has received $ 9.7

million of funds from the CPRIT grant.

The Company recorded $ 4.4 million of grant income related to the CPRIT grant as revenue during the year ended December 31, 2024 and at December 31, 2024, the Company recorded $ 2.1 million of grant income receivable.

In September 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 clinical investigation of MT-401 for the treatment of post-transplant AML.

Through the date of this filing, the Company has received $ 1.0 million from the FDA grant.

The Company recorded $ 0.5 million of grant income related to the FDA grant as revenue during the year ended December 31, 2024 and at December 31, 2024, the Company had no grant income receivable recorded.

In May 2023, the Company announced that it had received a $ 2.0 million grant from the National Institutes of Health Small Business Innovation Research (“SBIR”) program to support the development and investigation of MT-401 for the treatment of AML patients following standard-of-care therapy with hypomethylating agents.

Through the date of this filing, the Company has received $ 1.2 million from SBIR.

The Company recorded $ 1.0 million of grant income related to the SBIR grant as revenue during the year ended December 31, 2024 and at December 31, 2024, the Company recorded $ 0.2 million of grant income receivable.

In February 2025, the Company received $ 0.2 million of funds from the SBIR grant.

All funding agencies have agreed to continue their financial support and to shift funds to the MT-401-OTS program.

The above funding agencies have agreed to continue their financial support and to shift funds to the MT-401-OTS program.

In June 2024, the Company received notice of a $ 2.0 million grant over a 2 -year period from the National Institutes of Health - National Cancer Institute (“NIH”) to support control over tumor immune escape in pancreatic cancer using a dual T cell product strategy.

Through the date of this filing, the Company has received approximately $ 6,000 from NIH for this grant.

The Company recorded approximately $ 6,000 of grant income related to the NIH grant as revenue during the year ended December 31, 2024 and at December 31, 2024, the Company recorded approximately $ 6,000 of grant income receivable.

In February 2025, the Company received approximately $ 6,000 of funds from the NIH grant.

In August 2024, the Company received notice of a $ 2.0 million grant from the SBIR program to support the clinical investigation of MT-601 in patients with non-Hodgkin’s lymphoma (NHL) who have relapsed following anti-CD19 chimeric antigen receptor (CAR) T cell therapy.

Through the date of this filing, the Company has received $ 0.7 million of funds from this grant.

The Company recorded $ 0.7 million of grant income related to this grant as revenue for the year ended December 31, 2024 and at December 31, 2024, the Company had no grant income receivable recorded.

In August 2024, the Company received another $ 2.0 million grant from the National Institutes of Health SBIR program to support the advancement of MT-601 in patients with pancreatic cancer.

Through the date of this filing, the Company has received approximately $ 7,000 from NIH for this grant.

The Company recorded approximately $ 7,000 of grant income related to the NIH grant as revenue during the year ended December 31, 2024 and at December 31, 2024, the Company recorded approximately $ 7,000 of grant income receivable.

In February 2025, the Company received approximately $ 7,000 of funds from the NIH grant.

In December 2024, the Company received notice of an additional $ 9.5 million grant from CPRIT to support the clinical investigation of MT-601 in patients with metastatic pancreatic cancer.

Through the date of this filing, the Company has not received any funds from this grant.

In December 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, 2023, the Company sold 12,500 shares of its common stock under the Purchase Agreement for proceeds of approximately $ 33,000 .

For the year ended December 31, 2024, 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.

On February 29, 2024, the Company terminated the Purchase Agreement with Lincoln Park effective March 1, 2024.

As described in Note 1, on June 26, 2023, the Company completed the transaction with Cell Ready pursuant to the Cell Ready Purchase Agreement for total consideration of $ 19.0 million.

On February 22, 2024, the Company entered into a Master Services Agreement for Product Supply (the “MSA”) with Cell Ready, a contract development and manufacturing organization (CDMO).

Under the MSA, it is anticipated Cell Ready will perform a wide variety of services for us, including research and development, and manufacturing in support of our clinical trials.

Pursuant to the MSA, the Company may contract with Cell Ready for the provision of various products and services from time to time by entering into work orders with Cell Ready.

On December 19, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”), pursuant to which the Company issued and sold in a private Placement the following securities:

(i) 1,783,805 shares of common stock, (ii) Series B Warrants, or Pre-Funded Warrants, to purchase an aggregate of 3,247,445 shares of common stock in lieu of shares of common stock and (iii) Series A Warrants, or Private Placement Warrants, to purchase an aggregate of 5,031,250 shares of common stock.

The purchase price per share of common stock and accompanying Private Placement Warrant to purchase a share of common stock was $ 3.20 , and the purchase price per Pre-Funded Warrant and accompanying Private Placement Warrant to purchase a share of common stock was $ 3.199 .

Net proceeds from the sale of securities in the Private Placement was approximately $ 14.9 million, which does not include any proceeds that may be received upon exercise of any warrants issued in the Private Placement.

Both the Pre-Funded Warrants and the Private Placement Warrants are not exercisable until the Company obtains shareholder approval.

On March 21, 2025, the Company obtained shareholder approval for the exercise of such warrants.

The transaction closed on December 23, 2024.

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

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, 2023, including drawdowns of available grant funds, will enable the Company to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2025.

Prior to the Cell Ready transaction, there was substantial doubt regarding the Company’s ability to continue as a going concern, which was alleviated by the proceeds from the transaction.

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.

Based on the Company’s lack of recurring revenues, anticipated uses of cash and historical recurring cash losses from operating activities, and cash and cash equivalents as of December 31, 2024, the Company anticipates that it will be able to fund its operating expenses and capital expenditure requirements into the first quarter of 2026, assuming no additional grant funds are received.

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

Management currently plans to raise additional capital through the issuance of common shares and receipt of additional grant funds, which could enable the Company to fund its operating expenses and capital expenditure requirements beyond the first quarter of 2026, although no assurance can be given that such capital or existing awarded grants will be earned or future grants will be awarded.

The Company’s future cash requirements are based on the Company’s clinical and research and development plans, timing expectations related to the progress of its programs, and is subject to the Company’s ability to effectively manage its costs, raise additional capital, and receive additional grant funds.

The Company’s assumptions may prove to be wrong, and the Company could utilize its available capital resources sooner than it currently expects.

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.

1 unchanged sentence

The Company’s future funding requirements will depend on many factors, as it:

● initiates or continues clinical trials of its product candidates;

● Initiates, continues, or accelerates clinical trials of its product candidates;

● continues the research and development of its product candidates and seeks to discover additional product candidates;

1 unchanged sentence

● maintains and enforces intellectual property rights;

● enters into contract manufacturing arrangements with Cell Ready or other contract manufacturing organizations for clinical manufacturing supply;

● enters into contract manufacturing arrangements with contract manufacturing organizations for clinical manufacturing supply;

● establishes sales, marketing and distribution infrastructure and scale-up manufacturing capabilities to commercialize any product candidates that may receive regulatory approval;

1 unchanged sentence

● 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.

The Company does not have sufficient sources of revenue to provide incoming cash flows to sustain its future operations beyond the fourth quarter of 2025.

As outlined above, its ability to pursue its long-term planned business activities is dependent upon its successful efforts to raise additional capital and grant income.

The current macro-economic environment of 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.

The Company’s 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.

The Company’s 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.

In addition to the foregoing, the current macro-economic environment of decades-high inflation and concerns about an economic recession in the United States or other major markets have 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.

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The Company maintains cash in accounts which are in excess of the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $ 250,000 .

As of December 31, 2023 and December 31, 2022, the Company had approximately $ 1.4 .

million and $ 2.3 million, respectively in cash at financial institutions.

As of December 31, 2024 and December 31, 2023, the Company had approximately $ 1.1 million and $ 1.4 million, respectively in cash at financial institutions.

As of December 31, 2024, the Company had approximately $ 18.1 million in U.S.

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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, 2023 and 2022, no liability for unrecognized tax benefits was required to be reported.

As of December 31, 2024 and 2023, no liability for unrecognized tax benefits was required to

The guidance also discusses the classification of related interest and penalties on income taxes.

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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.

For grant and awards outside the scope of ASC 808, the Company applies either ASC 606 or IAS 20 by analogy depending on if the arrangement is considered an exchange or non-exchange transaction, respectively.

Under both accounting frameworks, 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.

During the two years ended December 31, 2024, the Company did not participate in any collaboration agreements.

Loss per Common Share

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Diluted loss per share includes the weighted average common shares outstanding and any potentially dilutive common stock equivalent shares in the calculation.

Segment Reporting

The Company adopted Accounting Standard Update (“ASU”) 2023-07, Segment Reporting (Topic 280) – Improvements to Reportable Segment Disclosures, as of January 1, 2024.

See the section Recently Adopted Accounting Standards below for more information.

Operating segments are defined as components of an entity for which separate discrete financial information is made available and that is regularly evaluated by the chief operating decision maker (“CODM”) in making decisions regarding resource allocation and assessing performance.

The Company 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 operations are organized and reported as a single reportable segment, which includes all activities related to the discovery, development, and commercialization of its products.

The Company’s CODM, its chief executive officer, reviews operating results on an aggregate basis and manages the operations as a single operating segment.

The accounting policies of the Company’s single operating and reportable segment are the same as those described in the summary of significant accounting policies.

The measure of segment assets is reported on the consolidated balance sheets as total assets.

The CODM evaluates performance and allocates resources based on consolidated net income (loss) that also is reported on the consolidated statements of operations as net loss, and consolidated cash used in operations.

The Company’s significant expenses are consistent with the expenses presented on the consolidated statement of operations.

The CODM makes operating decisions based on the availability of cash and the allocation of cash to the required expenditures.

Expenses are not regularly provided to the CODM on a more disaggregated basis for purposes of assessing segment performance and deciding how to allocate resources.

New Accounting Standards

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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.

Recently Issued Accounting Standards Not Yet Adopted

Recently Adopted Accounting Standards

Improvements to Reportable Segment Disclosures

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The ASU requires disclosures to include significant segment expenses that are regularly provided to the chief operating decision maker, among other provisions.

The ASU is effective for fiscal year periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024.

Early adoption is permitted and the ASU requires retrospective application to all prior periods presented in the financial statements.

The Company is currently evaluating the standard to determine the impact of adoption to its consolidated financial statements and disclosures.

Effective January 1, 2024, the Company adopted the new standard on a retrospective basis for annual periods, and interim periods beginning the first quarter of 2025.

The Company does not believe the impact of the new guidance and related codification improvements had a material impact to its financial position, results of operations and cash flows.

Recently Issued Accounting Standards Not Yet Adopted

Improvements to Income Tax Disclosures

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We do not expect the adoption of this guidance to have a material impact on its consolidated financial statements.

Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures

In November 2024, the FASB issued ASU No.

2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures, to improve transparency in financial reporting by requiring entities to present more detailed information about the nature of expenses included within the Income Statement.

The guidance will be effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027.

Early adoption is permitted.

Upon adoption, the guidance can be applied prospectively or retrospectively.

The Company is in the process of assessing the impact of ASU 2024-03 on its disclosures.

NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS

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( 8,236,814 )

( 29,930,694 )

Weighted average common shares outstanding, basic

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At December 31, 2024, the Company recorded $ 2.1 million of grant income receivable related to the CPRIT grant.

Additionally, the Company recorded $ 0.4 million and $ 0.2 million of grant income related to the FDA and SBIR grants, respectively, for the year ended December 31, 2023.

At December 31, 2023, the Company recorded $ 0.3 million and $ 0.2 million of grant income receivable related to the FDA and SBIR grants, respectively.

The Company received $ 0.3 million and $ 0.2 million of funds from FDA and SBIR in February 2024, respectively.

Additionally, the Company recorded $ 0.5 million and $ 1.0 million of grant income related to the FDA and SBIR grants related to MT - 401, respectively, for the year ended December 31, 2024.

At December 31, 2024, the Company recorded nil and $ 0.2 million of grant income receivable related to the FDA and SBIR grants, respectively.

The Company received $ 0.2 million of funds from SBIR in February 2025.

The Company also recorded approximately $ 6,000 and $ 7,000 of grant income related to the National Institutes of Health grants related to the advancement of MT-601 in patients with pancreatic cancer.

The Company received $ 6,000 and $ 7,000 , respectively, from the National Institutes of Health grants related to the advancement of MT-601 in patients with pancreatic cancer.

DISCONTINUED OPERATIONS

As discussed in Note 1, on June 26, 2023, the Company completed the previously announced transaction with Cell Ready for cash consideration of $ 19.0 million, resulting in derecognition of the Purchased Assets and a gain on sale of approximately $ 8.7 million, net of $ 63,000 in tax.

The assets and liabilities classified in discontinued operations as of December 31, 2023 and 2022 are as follows:

Prepaid expenses and other current assets

Total current assets of discontinued operations

Right of use assets

Total non-current assets of discontinued operations

Total assets of discontinued operations

Accounts payable

Related party deferred revenue

Short-term lease liabilities

Total current liabilities of discontinued operations

Long-term lease liabilities

Total non-current liabilities of discontinued operations

Total liabilities of discontinued operations

Net loss from discontinued operations consists of the following for the years ended December 31, 2023 and 2022, respectively, excluding the gain on disposal:

For the Years Ended

There were no assets and liabilities classified in discontinued operations as of December 31, 2024 and 2023, respectively.

The Company had no activity related to discontinued operations for the year ended December 31, 2024.

Net loss from discontinued operations consists of the following for the year ended December 31, 2023, excluding the gain on disposal:

For the Year Ended

Service revenue

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( 2,922,406 )

( 10,154,779 )

The following table summarizes our cash flows for the years ended December 31, 2023 and 2022:

For the Years Ended

Continuing operations:

Net cash used in operating activities

( 10,341,000 )

( 21,513,000 )

Net cash provided by financing activities

The following table summarizes our cash flows related to discontinued operations for the year ended December 31, 2023:

For the Year Ended

Discontinued operations:

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( 6,099,000 )

( 5,459,000 )

Net cash provided by (used in) investing activities

( 4,945,000 )

Net increase (decrease) in cash and cash equivalents

( 31,715,000 )

Net cash provided by investing activities

Net increase in cash and cash equivalents from discontinued operations

Related Party Service Revenue

In April 2022, the Company entered into a binding services agreement (“Wilson Wolf Agreement”) 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.

John Wilson was a member of the Company’s board of directors at the time of the agreement 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 Wilson Wolf 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.

In March 2023, the Company recognized the final $ 2.5 million of revenue pursuant to this $ 8.0 million agreement and an additional $ 1.0 million because the Work Direction was completed within one year from the onset of the Wilson Wolf Agreement, achieving the agreed milestone.

In March 2023, the Company recognized the final $ 2.5 million of revenue pursuant to this $ 8.0 million agreement and an additional $ 1.0 million because the work was completed within one year from the onset of the Wilson Wolf Agreement, achieving the agreed milestone.

The Wilson Wolf Agreement and related service obligations were completed upon achievement of this final milestone, and no obligations remain.

Service Revenue

In April 2023, the Company signed the Indapta Master Services Agreement, pursuant to which the Company provided services to Indapta.

Under an executed work order of that agreement, now complete, the Company recognized $ 0.8 million for the services during the period ended June 30, 2023.

Effective as of the closing date of the Purchase Agreement with Cell Ready, the rights and obligations to the Indapta Agreement were transferred to Cell Ready, and as such the revenues and expenses are reflected in discontinued operations.

PROPERTY AND EQUIPMENT

Substantially all of the previously reported property and equipment was disposed of as a result of the Cell Ready transaction.

Discontinued Operations for details.

Substantially all of the previously reported leases were disposed of as a result of the Cell Ready transaction.

Discontinued Operations for details.

ACCOUNTS PAYABLE, ACCRUED LIABILITIES, AND RELATED PARTY PAYABLE

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Related party payable

Arbitration settlement fees

Total accounts payable and accrued liabilities

The $ 1.7 million related-party payable reflects amounts payable to Cell Ready for outsourced product development and manufacturing services.

This amount was paid during February 2024.

Related Party Transactions.

This amount was paid during January 2025.

See Note 12 for additional information.

STOCKHOLDERS’ EQUITY

Increase in Authorized Shares

During June 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

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2024 Common Stock Transactions

Private Placement

Net proceeds from the sale of securities in the Private Placement was approximately $ 14.9 million, which does not include any proceeds that may be received upon the exercise of any warrants issued in the Private Placement.

Both the Pre-Funded Warrants and the Private Placement Warrants are not exercisable until the Company obtains shareholder approval.

On March 21, 2025, the Company obtained shareholder approval for the exercise of such warrants.

The transaction closed on December 23, 2024.

Issuance of Stock Pursuant to ATM Agreement

During the year ended December 31, 2024, the Company sold 8,178 shares of its common stock under the ATM Agreement for gross proceeds of $ 37,000 .

On June 10, 2024, the Company provided notice of its termination of the ATM Agreement with Cantor Fitzgerald & Co.

and RBC Capital Markets, LLC.

In November 2024, the Company entered into an ATM Agreement with H.C.

Wainwright & Co., LLC.

Exercise of Stock Options

During the year ended December 31, 2024, certain outstanding options were exercised for 25,602 shares of common stock providing aggregate proceeds to the Company of approximately $62,000 .

2023 Common Stock Transactions

Issuance of Stock Pursuant to ATM Agreement

During the year ended December 31, 2023, the Company sold 265,334 shares of its common stock under the ATM Agreement for net proceeds of $ 1.0 million.

8 unchanged sentences

During the year ended December 31, 2023, certain outstanding options were exercised for 27,518 shares of common stock providing aggregate proceeds to the Company of approximately $ 0.1 million.

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 with Lincoln Park

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

Share Purchase Warrants

A summary of the Company’s share purchase warrants as of December 31, 2023 and 2022, respectively, and changes during the period is presented below:

Weighted Average

Remaining Contractual

Total Intrinsic

Exercise Price

Life (in years)

Balance - January 1, 2022

Expired or cancelled

Balance - December 31, 2022

Expired or cancelled

( 1,848,000 )

Balance - December 31, 2023

All warrants outstanding at December 31, 2022 expired according to their terms on October 16, 2023.

As of December 31, 2023, the Company had no outstanding warrants.

Warrant Summary

The following table summarizes the total warrants outstanding at December 31, 2024:

Private placement warrants

December 2024

5 years from shareholder approval

Pre-funded warrants

December 2024

5 years from shareholder approval

STOCK BASED COMPENSATION

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2024 Equity Incentive Awards

On February 12, 2025, pursuant to the Company’s 2020 Equity Incentive Plan, the compensation committee of the Company’s board of directors approved 50,000 options to purchase the Company’s common stock as equity-based incentive awards to the Company’s Chief Executive Officer and President, Dr.

Juan Vera and 30,000 options to purchase the Company’s common stock as equity-based incentive awards to each Non-Employee Director.

Each option award was granted with an exercise price of $ 1.59 per share, the closing price of the Company’s common stock on the Nasdaq Capital Market on February 12, 2025, with the option award vesting in three annual installments, subject to such Optionee’s continued service on the applicable vesting date.

2023 Equity Incentive Awards

On February 27, 2023, pursuant to the Company’s 2020 Equity Incentive Plan, the compensation committee of the Company’s board of directors approved a total of 316,855 options to purchase the Company’s common stock as equity-based incentive awards to the Company’s executive officers and management team.

Each option award was granted with an exercise price of $ 2.14 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on February 27, 2023, 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.

Each option award was granted with an exercise price of $ 2.14 per share, the closing price of the Company’s common stock on the Nasdaq Capital Market on February 27, 2023, 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 27, 2023, the compensation committee of the Company’s board of directors approved a total of 87,677 options to purchase the Company’s common stock to non-executive employees and management team of the Company as equity-based incentive awards.

Each option award was granted with an exercise price of $ 2.14 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on February 27, 2023, 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.

Each option award was granted with an exercise price of $ 2.14 per share, the closing price of the Company’s common stock on the Nasdaq Capital Market on February 27, 2023, 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 7,000 stock option awards issued during the three months ended March 31, 2023 to new employees upon their commencement of employment with the Company.

Each option award was granted with an exercise price of $ 2.769 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on January 3, 2023, 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.

Each option award was granted with an exercise price of $ 2.769 per share, the closing price of the Company’s common stock on the Nasdaq Capital Market on January 3, 2023, 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.

On May 10, 2023, the Company’s board of directors approved a one-time share option grant of 100,000 shares of common stock to Dr.

Vera for his appointment as the Company’s Chief Executive Officer.

The option has a term of ten years and will vest in equal annual

installments on May 10, 2024, May 10, 2025, May 10, 2026, and May 10, 2027, subject to Mr.

The option has a term of ten years and will vest in equal annual installments on May 10, 2024, May 10, 2025, May 10, 2026, and May 10, 2027, subject to Mr.

Vera’s continued service to the Company as of the applicable vesting date.

Each option award was granted with an exercise price of $ 1.42 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on May 10, 2023.

Each option award was granted with an exercise price of $ 1.42 per share, the closing price of the Company’s common stock on the Nasdaq Capital Market on May 10, 2023.

On June 6, 2023, pursuant to the Company’s Non-Employee Director Compensation Policy, which had previously been approved by the Company’s board of directors, a total of 32,000 stock option awards were issued to independent members of the board of directors of the Company.

Each option award was granted with an exercise price of $ 1.72 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on June 6, 2023.

Each option award was granted with an exercise price of $ 1.72 per share, the closing price of the Company’s common stock on the Nasdaq Capital Market on June 6, 2023.

Each Option award will vest in one year subject to the director’s continuance of service through June 6, 2024.

2 unchanged sentences

$ 0.2 million is reflected in loss from discontinued operations.

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 $ 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.

Each option award was granted with an exercise price of $ 10.00 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on January 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.

21,000 stock option awards were issued during the three months ended June 30, 2022 to new employees upon their commencement of employment with the Company.

Each option award was granted with an exercise price of $ 4.30 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on April 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.

10,000 stock option awards were issued during the three months ended September 30, 2022 to new employees upon their commencement of employment with the Company.

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.

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, 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 vested over one year subject to the director’s continuance of service through May 24, 2023.

As of December 31, 2024, approximately 1.2 million shares of common stock are available to be issued under the 2020 Plan.

40 unchanged sentences

At December 31, 2024, the Company had recorded $ 2.1 million as other receivable, which represented grant income earned in advance of the next tranche of funds to be received from CPRIT.

In December 2024, the Company received notice an additional $ 9.5 million grant from CPRIT to support the clinical investigation of MT-601 in patients with metastatic pancreatic cancer.

The Company did no t record any grant income related to this grant for the year ended December 31, 2024.

Both CPRIT grants are subject to certain revenue-sharing arrangements, as per the grant agreements (see Note 11).

In September 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.

The Company recorded $ 0.5 million and $ 0.4 million of grant income related to the FDA grant as revenue for the years ended December 31, 2024 and December 31, 2023, respectively.

As of December 31, 2023, the Company recorded $ 0.3 million as other receivable, which represented grant income earned in advance of funds to be received from the FDA.

In February 2024, the Company received $ 0.3 million of funds from the FDA grant.

As of December 31, 2024, the Company had no other receivable recorded with respect to the FDA grant.

In May 2023, the Company announced it had received a $ 2.0 million grant from the National Institutes of Health Small Business Innovation Research program to support the development and investigation of MT-401 for the treatment of AML patients following standard-of-care therapy with hypomethylating agents.

The Company recorded $ 0.2 million of grant income related to the SBIR grant as revenue for the year ended December 31, 2023.

The Company recorded $ 1.0 million and $ 0.2 million of grant income related to the SBIR grant as revenue for the years ended December 31, 2024 and December 31, 2023, respectively.

As of December 31, 2024, the Company recorded $ 0.2 million as other receivable, which represented grant income earned in advance of funds to be received from the SBIR.

In February 2025, the Company received $ 0.2 million of funds from the SBIR grant.

All funding agencies have agreed to continue their financial support and to shift funds to the MT-401-OTS program.

In August 2024, the Company received notice of a $ 2.0 million grant from the National Institutes of Health Small Business Innovation Research Program to support the clinical investigation of MT-601 in patients with non-Hodgkin’s lymphoma (NHL) who have relapsed following anti-CD19 chimeric antigen receptor (CAR) T cell therapy.

The Company recorded $ 0.7 million of grant income related to this grant as revenue for the year ended December 31, 2024.

As of December 31, 2024, the Company had no other receivable recorded related to this grant.

In August 2024, received notice of another $ 2.0 million grant from the National Institutes of Health Small Business Innovation Research Program to support the clinical investigation of MT-601 in patients with pancreatic cancer.

The Company recorded approximately $ 7,000 of grant income for the year ended December 31, 2024 and recorded the same amount in other receivables as of December 31, 2024.

NIH – National Cancer Institute

In June 2024, the Company received notice of a $ 2.0 million grant over a 2-year period from the National Institutes of Health - National Cancer Institute to support control over tumor immune escape in pancreatic cancer using a dual T cell product strategy.

The Company recorded approximately $ 6,000 of grant income for the year ended December 31, 2024 and recorded the same amount in other receivables as of December 31, 2024.

COMMITMENTS AND CONTINGENCIES

Cancer Prevention and Research Institute of Texas

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 clinical investigation of MT-401.

In December 2024, the Company received notice of an additional $ 9.5 million grant from CPRIT to support the clinical investigation of MT-601 in patients with pancreatic cancer.

Both CPRIT grants contain identical terms surrounding intellectual property and revenue sharing.

Per the CPRIT grant agreements, the Company will retain ownership over any intellectual property developed under the contracts (the “Project Results”).

With respect to non-commercial use of any Project Results, the Company agreed to grant to CPRIT a nonexclusive, irrevocable, royalty-free, perpetual, worldwide license with the right to sublicense any necessary additional intellectual property rights to exploit all Project Results by CPRIT, other governmental entities and agencies of the State of Texas, and private or independent institutions of higher education located in Texas, solely for academic, research, and other non-commercial purposes.

If the Company’s products become commercially saleable, the Company is obligated to make payments to CPRIT, with respect to net sales of any product covered in the contract, equal to a percentage of revenue ranging from the low-to-mid single digits.

These payments will continue up to and until CPRIT receives an aggregate amount of 400 % of the sum of all monies paid to the Company by CPRIT under the grant agreements.

If the Company is required to obtain a license from a third party to sell any such product, the revenue sharing percentages may be reduced.

In addition, once the Company has paid CPRIT 400 % of the monies received under the grant agreements, the Company will continue to pay CPRIT a revenue-sharing percentage of 0.5 % for the remainder of the Revenue Term as specified in the grant agreement.

License Agreement with the Baylor College of Medicine

In March 2018, the Company entered into an exclusive license agreement with BCM under which the Company acquired a worldwide, exclusive license to BCM’s rights in and to certain intellectual property rights, including a European patent to develop and commercialize MAR-T cell product candidates (the “BCM License Agreement”).

In exchange for the license, the Company issued shares of its common stock to BCM valued at approximately $ 5.0 million at the time of issuance, agreed to make royalty payments to BCM upon commercial sales according to the royalty schedule in the BCM License Agreement, under which the royalty percentages increase in proportion to the aggregate net sales, and agreed to pay BCM certain milestone payments up to an aggregate of $ 64.85 million.

The milestone payments are based upon the occurrence of nine particular milestones relating to completion of the first dosing in clinical trials for a first and second distinct product, FDA approval, and achievement of certain net sales goals.

The Company is also responsible for sublicensing fees and for reimbursing BCM for related-party expenses.

In addition, upon a liquidity event (as defined in the BCM License Agreement) of the Company, BCM will receive a one-time liquidity incentive payment of 0.5 % of the liquidity event proceeds (as defined in the BCM License Agreement).

Legal Proceedings

From time to time, the Company may be party to ordinary, routine litigation incidental to their business.

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.

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.

From time to time, we may become involved in legal proceedings, including those arising in the ordinary course of our business.

We are not currently a party to any material legal proceedings that we believe could have an adverse effect on our business, operating results or financial condition.

RELATED PARTY TRANSACTIONS

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Baylor College of Medicine

Bio-Techne Corporation

Wilson Wolf Manufacturing Corporation

Total Research and development

$1.3 million of related party transactions are included in accounts payable and accrued liabilities as of December 31, 2023.

As of December 31, 2024 and 2023, $ 1.7 million and $ 1.3 million, respectively, of related party transactions are included in accounts payable and accrued liabilities.

See Note 7 for additional information.

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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.

BCM is also a shareholder of the Company’s common stock.

The Company has also entered into a Clinical Site Agreement with BCM, which provided for BCM to conduct clinical trials for the Company and is a part of continuing operations.

Purchases from Bio-Techne Corporation .

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 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.

BCM is also a shareholder of the Company’s common stock.

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.

In 2023, the Company utilized Wilson Wolf for the purchases of cell culture devices.

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

Purchases from Cell Ready, LLC.

The Company is currently utilizing Cell Ready, LLC for its clinical manufacturing supply and product development.

John Wilson is a member of the Company’s board of directors and is serving as the CEO of Cell Ready, LLC.

On February 22, 2024, we entered into a Master Services Agreement for Product Supply (the “MSA”) with Cell Ready.

Cell Ready, which is owned by one of our directors and shareholders, Mr.

The Company has utilized Cell Ready, LLC for clinical manufacturing supply and product development.

On February 22, 2024, we entered into a 3-year Master Services Agreement for Product Supply (the “MSA”) with Cell Ready.

Cell Ready, which is owned by a former director and current shareholder, Mr.

John Wilson, is a contract development and manufacturing organization (CDMO).

Under the MSA, it is anticipated Cell Ready will perform a wide variety of services for us, including research and development, and manufacturing in support

of our clinical trials.

Pursuant to the MSA, the Company may contract with Cell Ready for the provision of various products and services from time to time by entering into work orders with Cell Ready.

If the services involve the supply of product, Cell Ready is required to supply such product in conformance with the product requirements set forth in the applicable work order(s).

Further, Cell Ready is required to provide the Company with assistance and cooperation in order for the Company to obtain and maintain all necessary regulatory approvals, at the Company’s expense.

Also on February 22, 2024, the Company entered into Work Order #1 under the MSA, pursuant to which Cell Ready will provide the Company with GMP drug product for Marker MT-401 and/or MT-601.

During the year ended December 31, 2024, the Company entered into Work Order #1 under the MSA, pursuant to which Cell Ready agreed to provide the Company with GMP drug product for Marker MT-401 and/or MT-601.

The services include the delivery of final drug product and quality control testing.

The Company also requested Cell Ready to provide general support services in connection therewith.

The total projected sum (inclusive of taxes) for the services under Work Order #1 are not anticipated to exceed $ 750,000 .

The services will cover the anticipated manufacturing costs for the first quarter of 2024.

Additional Work Orders are expected to be generated for the remainder of 2024.

The Company has no federal income tax expense due to operating losses incurred for the years ended December 31, 2023 and 2022.

The Company recognized $ 4,000 in state tax expense for the year ended December 31, 2023.

During the year ended December 31, 2024, the Company incurred $ 5.8 million in expenses related to the services and manufacturing costs and paid $ 5.5 million for invoices received.

The Company has no federal income tax expense due to operating losses incurred and utilized for the years ended December 31, 2024, and 2023, respectively.

The Company recognized $ 50,000 and $ 4,000 in state tax expense for the years ended December 31, 2024 and 2023, respectively.

The effects of temporary differences that give rise to significant portions of the deferred tax assets as of December 31, 2024 and 2023 are as follows:

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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, 2024 and 2023.

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

The research and development tax credit carryforwards begin to expire in 2030.

The Company has approximately $ 138.3 million of federal and $ 38.8 million of state Net Operating Losses (“NOL”s) that may be available to offset future taxable income, if any.

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The state net operating loss carryforwards of $ 16.9 million generated in 2018 and thereafter are subject to an 80 % limitation on taxable income, do not expire and will carry forward indefinitely.

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

The research and development tax credit carryforwards begin to expire in 2030.

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.

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SUBSEQUENT EVENTS

On February 22, 2024, the Company entered into a Master Services Agreement for Product Supply (the “Agreement”) with Cell Ready, a contract development and manufacturing organization (CDMO).

Cell Ready is owned by one of the Company’s directors and shareholders, Mr.

See Note 1 and Note 14.

On February 29, 2024, Marker Therapeutics, Inc.

(the “Company”) delivered notice to Lincoln Park Capital Fund, LLC, an Illinois limited liability company (“LPC”), terminating the Purchase Agreement, dated December 12, 2022 (the “Purchase Agreement”), with LPC effective March 1, 2024 (the “Termination Date”).

The Company projects a financial runway through the fourth quarter of 2025 and does not anticipate an immediate need for capital acquisition.

On March 21, 2025, the Company held a Special Meeting of Stockholders (the “Special Meeting”) at which the stockholders approved, in accordance with Nasdaq Listing Rule 5635(d), of the issuance of the shares issuable upon exercise of (i) Series A Warrants to acquire 5,031,250 shares of Common Stock and (ii) Series B Warrants to acquire 3,247,445 shares of Common Stock.

On March 27, 2025, the Company mutually agreed with Cell Ready to terminate the MSA.

In connection therewith, the Company entered into a settlement and release agreement with Cell Ready pursuant to which the Company paid Cell Ready approximately $ 453,000 and the parties provided one another with mutual releases of all claims associated with any and all agreements between Marker and Cell Ready.

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