Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We have established disclosure controls and procedures, as such term is defined in Rule 13a-15(e) under the Securities Exchange Act of 1934. Under the supervision and with the participation of our management, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of December 31, 2024 to ensure that the information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act of 1934 is accumulated and communicated to our management, including our principal executive officer and principal financial officer as appropriate, to allow timely decisions regarding required disclosure. 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, 2024. 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, 2024 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 Principal Financial Officer, to allow timely decisions regarding any required disclosure.
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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 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, 2024 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, 2024.
Cybersecurity
We utilize information technology for internal and external communications with vendors, clinical sites, banks, investors and shareholders. Loss, disruption or compromise of these systems could significantly impact operations and results.
We are not aware of any material cybersecurity violation or occurrence. We believe our efforts toward prevention of such violation or occurrence, including system design and controls, processes and procedures, training and monitoring of system access, limit, but may not prevent unauthorized access to our systems.
Other than temporary disruption to operations that may be caused by a cybersecurity breach, we consider cash transactions to be the primary risk for potential loss. We and our financial institution take steps to minimize the risk by requiring multiple levels of authorization and other controls.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) during the fiscal quarter ended December 31, 2024 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Inherent Limitations on Effectiveness of Internal Controls
In designing and evaluating the disclosure controls and procedures, management does not expect that our internal control over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control systems are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. 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 Principal Financial and 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.
ITEM 9B. 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.
(b)
Rule 10b5–1 trading arrangement. 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.
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ITEM 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this item and not set forth below will be set forth in the sections headed “Election of Directors,” “Executive Officers” and “Delinquent Section 16(a) Reports” in our definitive proxy statement for our 2024 Annual Meeting of Stockholders, or our Proxy Statement, to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2024 and is incorporated herein by reference.
We have adopted a written code of business conduct and ethics that applies to our directors, officers and employees, including our principal executive officer, principal financial and accounting officer or controller, or persons performing similar functions, known as the Code of Ethics and Business Conduct. The Code of Ethics and Business Conduct is available on our website at www.markertherapeutics.com under the Corporate Governance section of our Investors page. 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.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this item will be set forth in the section headed “Executive Compensation” in our Proxy Statement and is incorporated herein by reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
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.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
The information required by this item will be set forth in the section headed “Transactions with Related Persons and Indemnification” and “Information Regarding the Board of Directors and Corporate Governance” in our Proxy Statement and is incorporated herein by reference.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The information required by this item will be set forth in the section headed “Principal Accountant Fees and Services” in our Proxy Statement and is incorporated herein by reference.
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PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
(a)
The documents filed as part of this report are as follows:
1.
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.
2.
All financial statement schedules are omitted because they are inapplicable, not required or the information is included elsewhere in the financial statements or the notes thereto.
3.
The following is a list of exhibits filed as part of this Annual Report on Form 10-K.
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EXHIBIT INDEX
Incorporated by Reference
Exhibit
number
Exhibit description
Form
File no.
Exhibit
Filing
date
Filed
herewith
3.1
Certificate of Incorporation
8-K
001-37939
3.4
10/17/18
3.2
Certificate of Amendment to Certificate of Incorporation of Marker Therapeutics, Inc.
8-K
001-37939
3.1
5/27/22
3.3
Certificate of Amendment to Certificate of Incorporation of Marker Therapeutics, Inc.
8-K
001-37939
3.1
1/26/23
3.4
Bylaws of Marker Therapeutics, Inc.
8-K
001-37939
3.6
10/17/18
4.0
Form of Common Stock Certificate of Marker Therapeutics, Inc.
10-K
001-37939
4.0
3/25/24
4.1
Description of Securities of Marker Therapeutics, Inc.
10-K
001-37939
4.1
3/25/24
4.2
Form of Pre-Funded Warrant
8-K
001-37939
4.1
12/23/24
4.3
Form of Series A Warrant (Private Placement Warrant)
8-K
001-37939
4.2
12/23/24
10.1
Exclusive License Agreement between Baylor College of Medicine and Marker Therapeutics, Inc. dated March 16, 2018***
10-K
001-37939
10.21
3/15/19
10.2
Sponsored Research Contract between Baylor College of Medicine and Marker Therapeutics, Inc. dated November 16, 2018***
10-K
001-37939
10.22
3/15/19
10.4
Form of Director and Officer Indemnification Agreement*
10-K
001-37939
10.39
3/15/19
10.5
Marker Therapeutics, Inc. 2020 Equity Incentive Plan
S-8
333-239136
99.1
6/12/20
10.6
Form of Stock Option Grant Notice and Stock Option Agreement under the Marker Therapeutics, Inc. 2020 Equity Incentive Plan.
10-Q
001-37939
10.1
11/9/20
10.7
Securities Purchase Agreement dated December 19, 2024
8-K
001-37939
10.1
12/19/24
10.8
Registration Rights dated December 19, 2024
8-K
001-37939
10.2
12/23/24
10.9
At The Market Offering Agreement, dated as of November 27, 2024, between the Company and H.C. Wainwright & Co., LLC
S-3
333-283515
1.1
11/27/24
10.10
Master Services Agreement for Product Supply between Marker Therapeutics, Inc. and Cell Ready LLC dated February 22, 2024**
10-K
001-37939
10.8
3/25/24
19.1
Insider Trading Policy
X
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Incorporated by Reference
Exhibit
number
Exhibit description
Form
File no.
Exhibit
Filing
date
Filed
herewith
21.1
List of Subsidiaries
X
23.1
Consent of Marcum LLP, an independent public accounting firm.
X
24.1
Powers of Attorney (included on signature page)
X
31.1
Certification of Chief Executive Officer pursuant to Securities Exchange Act of 1934 Rule 13a-14(a) or 15d-14a
X
31.2
Certification of Chief Financial Officer pursuant to Securities Exchange Act of 1934 Rule 13a-14(a) or 15d-14a
X
32.1
Certification of Chief Executive Officer pursuant to 18 U. S. C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002#
X
32.2
Certification of Chief Financial Officer pursuant to 18 U. S. C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002#
X
97
Incentive Compensation Recoupment Policy
10-K
001-37939
97
3/25/24
101.INS
XBRL Instance Document
X
101.SCH
XBRL Taxonomy Extension Schema Document
X
101.CAL
XBRL Taxonomy Extension Calculation Linkbase Document
X
101.DEF
XBRL Taxonomy Extension Definition Linkbase Document
X
101.LAB
XBRL Taxonomy Extension Label Linkbase Document
X
101.PRE
XBRL Taxonomy Extension Presentation Linkbase Document
X
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101 filed herewith)
*
Executive management contract or compensatory plan or arrangement.
**
Confidential treatment has been granted as to certain portions of this exhibit pursuant to Rule 406 of the Securities Act of 1933, as amended, or Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
***
Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for conditional treatment and this exhibit has been submitted separately with the SEC.
#
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
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reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
ITEM 16. FORM 10-K SUMMARY
None.
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SIGNATURES
Pursuant to the requirements of Section 13 and 15 (d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Dated: March 31, 2025
Marker Therapeutics, Inc.
By:
/s/ Juan Vera
Juan Vera
Chief Executive Officer and Treasurer (Principal Executive Officer and Principal Financial and Accounting Officer)
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POWER OF ATTORNEY
Each of the undersigned officers and directors of Marker Therapeutics, Inc., hereby constitutes and appoints Juan Vera 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 31, 2025 on behalf of the registrant and in the capacities indicated.
Signature
Title
Date
/s/ Juan Vera
President, Chief Executive Officer and Treasurer, Director (Principal Executive Officer and Principal Financial and Accounting Officer)
March 31, 2025
Juan Vera
/s/ N. David Eansor
Chairman
March 31, 2025
N. David Eansor
/s/ Katharine Knobil
Director
March 31, 2025
Katharine Knobil
/s/ Steve Elms
Director
March 31, 2025
Steve Elms
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MARKER THERAPEUTICS, INC.
CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2024 AND DECEMBER 31, 2023
Report of Independent Registered Public Accounting Firm (PCAOB ID Number 688 )
F-2
Consolidated Balance Sheets
F-3
Consolidated Statements of Operations
F-4
Consolidated Statements of Stockholders’ Equity
F-5
Consolidated Statements of Cash Flows
F-6
Notes to the Consolidated Financial Statements
F-7
F-1
Table of Contents
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and Board of Directors of
Marker Therapeutics, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Marker Therapeutics, Inc. (the “Company”) as of December 31, 2024 and 2023, the related consolidated statements of operations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “financial statements”). 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
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audits. 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.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
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. We determined that there are no critical audit matters.
/s/ Marcum LLP
Marcum LLP
We have served as the Company’s auditor since 2014.
Houston, TX
March 31, 2025
F-2
Table of Contents
MARKER THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
December 31,
December 31,
2024
2023
ASSETS
Current assets:
Cash and cash equivalents
$
19,192,440
$
15,111,450
Prepaid expenses and deposits
483,717
988,126
Other receivables
2,346,703
1,027,815
Total current assets
22,022,860
17,127,391
Total assets
$
22,022,860
$
17,127,391
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued liabilities
$
1,753,954
$
1,745,193
Related party payable
1,710,500
1,329,655
Total current liabilities
3,464,454
3,074,848
Total liabilities
3,464,454
3,074,848
Stockholders’ equity:
Preferred stock, $ 0.001 par value, 5 million shares authorized, 0 shares issued and outstanding at December 31, 2024 and 2023, respectively
—
—
Common stock, $ 0.001 par value, 30 million shares authorized, 10.7 million and 8.9 million shares issued and outstanding as of December 31, 2024 and 2023, respectively (see Note 8)
10,708
8,891
Additional paid-in capital
465,564,876
450,329,515
Accumulated deficit
( 447,017,178 )
( 436,285,863 )
Total stockholders’ equity
18,558,406
14,052,543
Total liabilities and stockholders’ equity
$
22,022,860
$
17,127,391
The accompanying notes are an integral part of these consolidated financial statements.
F-3
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MARKER THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
For the Years Ended
December 31,
2024
2023
Revenues:
Grant income
$
6,591,080
$
3,311,133
Total revenues
6,591,080
3,311,133
Operating expenses:
Research and development
13,467,845
10,416,789
General and administrative
4,241,607
7,475,722
Total operating expenses
17,709,452
17,892,511
Loss from operations
( 11,118,372 )
( 14,581,378 )
Other income (expenses):
Interest income
437,010
539,158
Loss from continuing operations before income taxes
( 10,681,362 )
( 14,042,220 )
Income tax expense
49,953
3,675
Net loss from continuing operations
( 10,731,315 )
( 14,045,895 )
Discontinued operations:
Loss from discontinued operations
—
( 2,922,406 )
Gain on disposal of discontinued operations, net of $ 63,000 in tax
—
8,731,487
Income (loss) from discontinued operations
—
5,809,081
Net loss
$
( 10,731,315 )
$
( 8,236,814 )
Net earnings (loss) per share:
Loss from continuing operations, basic and diluted
$
( 1.19 )
$
( 1.59 )
Income from discontinued operations, basic and diluted
$
—
$
0.66
Net loss per share, basic and diluted
$
( 1.19 )
$
( 0.94 )
Weighted average number of common shares outstanding:
Basic
8,980,207
8,809,382
Diluted
8,980,207
8,809,382
The accompanying notes are an integral part of these consolidated financial statements.
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MARKER THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
Additional
Total
Common Stock
Paid-
Accumulated
Stockholders’
Shares
Par value
in Capital
Deficit
Equity
Balance at January 1, 2023
8,405,771
8,406
447,641,680
( 428,049,049 )
19,601,037
Shares issued pursuant to ATM and Lincoln Park agreements
277,834
277
1,014,363
—
1,014,640
Issuance of common stock as commitment fee
180,410
180
( 180 )
—
—
Issuance of common stock from exercise of stock options
27,518
28
90,450
—
90,478
Stock-based compensation
—
—
1,583,202
—
1,583,202
Net loss
—
—
—
( 8,236,814 )
( 8,236,814 )
Fractional shares adjustment due to reverse split
( 113 )
—
—
—
—
Balance at December 31, 2023
8,891,420
8,891
450,329,515
( 436,285,863 )
14,052,543
Shares purchased pursuant to ATM agreement
8,178
8
36,894
—
36,902
Issuance of common stock from exercise of stock options
25,602
25
62,134
—
62,159
Issuance of common stock, prefunded warrants and warrants for cash, net of offering costs of $ 1.2 million
1,783,805
1,784
14,890,469
—
14,892,253
Stock-based compensation
—
—
245,864
—
245,864
Net loss
—
—
—
( 10,731,315 )
( 10,731,315 )
Balance at December 31, 2024
10,709,005
10,708
465,564,876
( 447,017,178 )
18,558,406
The accompanying notes are an integral part of these consolidated financial statements.
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MARKER THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Years Ended
December 31,
2024
2023
Cash Flows from Operating Activities:
Net loss
$
( 10,731,315 )
$
( 8,236,814 )
Less: gain from discontinued operations, net of $ 63,000 in tax
—
5,809,081
Net loss from continuing operations
( 10,731,315 )
( 14,045,895 )
Reconciliation of net loss to net cash used in operating activities:
Stock-based compensation
245,864
858,269
Changes in operating assets and liabilities:
Prepaid expenses and deposits
504,409
861,113
Other receivables
( 1,318,888 )
1,374,189
Related party payable
380,845
1,329,655
Accounts payable and accrued expenses
8,761
( 718,393 )
Net cash used in operating activities - continuing operations
( 10,910,324 )
( 10,341,062 )
Net cash used in operating activities - discontinued operations
—
( 6,098,899 )
Net cash used in operating activities
( 10,910,324 )
( 16,439,961 )
Cash Flows from Investing Activities:
Net cash provided by investing activities - discontinued operations
—
18,664,122
Net cash provided by investing activities
—
18,664,122
Cash Flows from Financing Activities:
Proceeds from issuance of common stock, prefunded warrants and warrants, net
14,929,155
1,014,640
Proceeds from stock options exercise
62,159
90,477
Net cash provided by financing activities
14,991,314
1,105,117
Net increase in cash and cash equivalents
4,080,990
3,329,278
Cash and cash equivalents at beginning of the year
15,111,450
11,782,172
Cash and cash equivalents at end of the year
$
19,192,440
$
15,111,450
For the Years Ended
December 31,
2024
2023
Supplemental schedule of non-cash financing and investing activities:
Issuance of common stock as commitment fee for future financing
$
—
$
180
The accompanying notes are an integral part of these consolidated financial statements.
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Table of Contents
MARKER THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE FISCAL YEARS DECEMBER 31, 2024 AND 2023
NOTE 1: 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 for the treatment of hematological malignancies and solid tumor indications. 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. The Company was incorporated in Nevada in 1992 and reincorporated in Delaware in October 2018.
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. Mr. 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. Mr. 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”). Cell Ready acquired the Purchased Assets for total consideration of $ 19.0 million. In connection with the purchase of the Manufacturing Facilities, Cell Ready also extended offers of employment to approximately 50 of the Company’s former employees in its manufacturing, development, quality, and regulatory affairs functions.
The Purchased Assets constituted a significant disposition. 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. See additional discussion at Note 6.
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.
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Organizational Changes
In 2023, the Company implemented changes to its organizational structure due to the transaction with Cell Ready and to reduce operational costs. In connection with these changes, the Company reduced headcount, including the separation of its former Chief Executive Officer, Peter Hoang, in May 2023 and its former Chief Accounting Officer, Michael Loiacono, in June 2023. During the second quarter of 2023, the Company recorded $ 0.9 million of severance and termination-related costs. The payments of these costs were completed in July of 2023. Effective May 1, 2023, the Company’s board of directors appointed Dr. Juan Vera as the Company’s President and Chief Executive Officer.
Effective June 30, 2023, the board of directors appointed Eliot M. Lurier as the Company’s Interim Chief Financial Officer, whereby Mr. Lurier provided consulting services to the Company pursuant to a consulting between the Company and Danforth Advisors, LLC (“Danforth”) and received no compensation directly from the Company. On November 17, 2023, the Company terminated the consulting agreement between the Company and Danforth, effective January 16, 2024.
On November 17, 2023, Mr. Lurier ceased serving as the Company’s Interim Chief Financial Officer and Dr. Vera was appointed as the Company’s Principal Financial and Accounting Officer.
NOTE 2: FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS
As of December 31, 2024, the Company had cash and cash equivalents of approximately $ 19.2 million. The Company’s activities since inception have consisted principally of acquiring product and technology rights, raising capital, and performing research and development. Successful completion of the Company’s development programs and, ultimately, the attainment of profitable operations are dependent on future events, including, among other things, its ability to access potential markets; secure financing; successfully progress its product candidates through preclinical and clinical development; obtain regulatory approval of one or more of its product candidates; maintain and enforce intellectual property rights; develop a customer base; attract, retain and motivate qualified personnel; and develop strategic alliances and collaborations. From inception, the Company has been funded by a combination of equity, debt financings and grants.
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 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. 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. LLC. 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. H.C. 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
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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.
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, 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.
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 .
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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 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. Because of the numerous risks and uncertainties associated with the development and commercialization of the Company’s product candidates and the extent to which the Company may enter into additional collaborations with third parties to participate in their development and commercialization, the Company is unable to estimate the amounts of increased capital outlays and operating expenditures associated with its current and anticipated clinical trials. The Company’s future funding requirements will depend on many factors, as it:
● 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;
● seeks regulatory approvals for any product candidates that successfully complete clinical trials;
● maintains and enforces intellectual property rights;
● 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;
● evaluates strategic transactions the Company may undertake; and
● 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’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.
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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.
NOTE 3: 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 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. generally accepted accounting principles (“GAAP”) as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).
Principles of Consolidation
These consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Marker Cell Therapy, Inc. and GeneMax Pharmaceuticals Inc. – a dormant subsidiary that wholly owns GeneMax Pharmaceuticals Canada, Inc. All significant intercompany balances and transactions are eliminated upon consolidation.
Use of Estimates
Preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Accordingly, actual results may differ materially from those estimates. Management considers many factors in selecting appropriate financial accounting policies, controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following areas, among others: stock-based compensation expense and income taxes.
Cash, Cash Equivalents and Credit Risk
The Company considers highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents at December 31, 2024 consisted of cash and certificates of deposit in institutions in the United States. Balances at certain institutions have exceeded Federal Deposit Insurance Corporation insured limits and U.S. government agency securities.
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, 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. government agency securities.
In the event cash is received from grants in advance of incurring qualifying costs, it is recorded as restricted cash until it is earned and recorded to grant income.
Discontinued Operations
The Purchased Assets sold to Cell Ready pursuant to the Cell Ready Purchase Agreement constituted a significant disposition and as such, the Company concluded that the disposition of its Purchased Assets represented a strategic shift that had a major effect on its operations and financial results. Therefore, the Purchased Assets, related party revenue, service revenue and related expenses are classified as discontinued operations for all periods presented herein. See Note 6 for further information.
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Patents and Patent Application Costs
Although the Company believes that its patents and underlying technology have continuing value, the amount of future benefits to be derived from the patents is uncertain. Patent costs are, therefore, expensed as incurred.
Stock-Based Compensation
The Company incurs stock-based compensation expense related to the issuance of common stock and stock options. The Company estimates the fair value of stock options granted using the Black-Scholes option pricing model. The Black-Scholes option pricing model was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. 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. The simplified method is based on the average of the vesting tranches and the contractual life of each grant.
Expected Volatility — The Company computes stock price volatility over expected terms based on its historical common stock trading prices.
Risk-Free Interest Rate — The Company bases the risk-free interest rate on the implied yield available on U.S. Treasury zero-coupon issues with an equivalent remaining term.
Expected Dividend — The Company has never declared or paid any cash dividends on its common shares and does not plan to pay cash dividends in the foreseeable future, and, therefore, uses an expected dividend yield of zero in its valuation models.
The Company amortizes the fair value of the awards expected to vest on a straight-line basis over the requisite service period of the awards. The Company recognizes fair value of stock options granted to nonemployees as stock-based compensation expense over the period in which the related services are received as if the Company had paid cash for those services. Forfeitures are accounted for as incurred.
Research and Development Costs
Research and development expenses consist of costs associated with clinical trial programs. Costs incurred by third parties are expensed as the contracted work is performed. The Company accrues for costs incurred as the services are being provided by monitoring the status of the clinical trial or project and the invoices received from its external service providers. The Company estimates depend on the timeliness and accuracy of the data provided by the vendors regarding the status of each project and total project spending. The Company adjusts its accrual as actual costs become known. Where contingent milestone payments are due to third parties under research and development arrangements, the milestone payment obligations are expensed when the milestone events are achieved.
Income Taxes
The Company follows the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of assets and liabilities and their respective tax balances. Potential deferred tax assets and liabilities are measured using enacted tax rates expected to apply to the taxable income in the years in which those differences are expected to be recovered or settled. The effect on potential deferred tax assets and liabilities of a change in tax rates is recognized in the statement of operations in the period that includes the date of allowances against deferred tax assets.
Tax benefits are recognized only for tax positions that are more likely than not to be sustained upon examination by tax authorities. The amount recognized is measured as the largest amount of benefit that is greater than 50 percent likely to be realized upon settlement. 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, 2024 and 2023, no liability for unrecognized tax benefits was required to
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be reported. The guidance also discusses the classification of related interest and penalties on income taxes. The Company’s policy is to record interest and penalties on uncertain tax positions as a component of income tax expense. No interest or penalties were recorded during the years ended December 31, 2024 and 2023.
Grant Income
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”). 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
Basic loss per share includes only the weighted average common shares outstanding, without consideration of potentially dilutive securities. 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
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date. 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.
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Recently Adopted Accounting Standards
Improvements to Reportable Segment Disclosures
In November 2023, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The ASU requires disclosures to include significant segment expenses that are regularly provided to the chief operating decision maker, among other provisions. 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
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which improves the transparency of income tax disclosures by requiring consistent categories and greater disaggregation of information in the effective tax rate reconciliation and income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. This guidance will be effective for the annual periods beginning the year ended December 31, 2025. Early adoption is permitted. Upon adoption, the guidance can be applied prospectively or retrospectively. 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.
NOTE 4: NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS
Basic loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the reporting period. Diluted loss per common share is computed similarly to basic loss per common share except that it reflects the potential dilution that could occur if dilutive securities or other obligations to issue common stock were exercised or converted into common stock.
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The following table sets forth the computation of net loss per share for the years ended December 31, 2024 and 2023, respectively:
For the Years Ended
December 31,
2024
2023
Numerator:
Loss from continuing operations
$
( 10,731,315 )
$
( 14,045,895 )
Income (loss) from discontinued operations
—
5,809,081
Net loss
$
( 10,731,315 )
$
( 8,236,814 )
Denominator:
Weighted average common shares outstanding, basic
8,980,207
8,809,382
Weighted average common shares outstanding, diluted
8,980,207
8,809,382
Net earnings (loss) per share:
Loss from continuing operations, basic and diluted
$
( 1.19 )
$
( 1.59 )
Income (loss) from discontinued operations, basic and diluted
$
—
$
0.66
Net loss per share, basic and diluted
$
( 1.19 )
$
( 0.94 )
The following securities, rounded to the thousand, were not included in the diluted net loss per share calculation because their effect was anti-dilutive for the periods presented:
For the Years Ended
December 31,
2024
2023
Common stock options
588,000
738,000
Common stock purchase warrants
8,279,000
—
Potentially dilutive securities
8,867,000
738,000
NOTE 5: OTHER RECEIVABLE
Qualifying grant income earned in advance of cash received from grants is recognized as revenue and recorded as other receivable. The Company recorded $ 4.4 million of grant income related to the CPRIT grant for the year ended December 31, 2024. At December 31, 2024, the Company recorded $ 2.1 million of grant income receivable related to the CPRIT grant.
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.
NOTE 6: 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.
There were no assets and liabilities classified in discontinued operations as of December 31, 2024 and 2023, respectively.
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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
December 31,
2023
Revenues:
Service revenue
$
816,641
Related party service revenue
3,500,000
Total revenues
4,316,641
Operating expenses:
Research and development
6,561,957
General and administrative
677,090
Total operating expenses
7,239,047
Loss from discontinued operations
$
( 2,922,406 )
The following table summarizes our cash flows related to discontinued operations for the year ended December 31, 2023:
For the Year Ended
December 31,
2023
Discontinued operations:
Net cash used in operating activities
$
( 6,099,000 )
Net cash provided by investing activities
18,664,000
Net increase in cash and cash equivalents from discontinued operations
$
12,565,000
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”). Mr. 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 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.
NOTE 7: ACCOUNTS PAYABLE, ACCRUED LIABILITIES, AND RELATED PARTY PAYABLE
Accounts payable, accrued liabilities, and related party payable consist of the following as of December 31, 2024 and 2023, respectively:
December 31,
December 31,
2024
2023
Accounts payable
$
1,066,000
$
961,000
Compensation and benefits
86,000
57,000
Professional fees
293,000
303,000
Related party payable
1,711,000
1,330,000
Tax fees
104,000
219,000
Other
204,000
205,000
Total accounts payable and accrued liabilities
3,464,000
3,075,000
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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 January 2025. See Note 12 for additional information.
NOTE 8: STOCKHOLDERS’ EQUITY
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, 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 historical share and per share amounts reflected in this report have been adjusted to reflect the Reverse Stock Split.
Preferred Stock
The Company has authorized up to 5,000,000 shares of preferred stock, $ 0.001 par value per share, for issuance. The preferred stock will have such rights, privileges and restrictions, including voting rights, dividend conversion rights, redemption privileges and liquidation preferences, as shall be determined by the Company’s board of directors upon its issuance. To date, the Company has not issued any preferred shares.
Common Stock
The Company has authorized up to 30,000,000 shares of common stock, $ 0.001 par value per share, for issuance. Significant 2024 and 2023 common stock transactions were as follows:
2024 Common Stock Transactions
Private Placement
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 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 .
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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.
Stock Purchase Agreement with Lincoln Park
In December 2022, the Company entered into a purchase agreement (the “Purchase Agreement”) with 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 (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 Purchase 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. In January 2023, Lincoln Park was issued 180,410 shares of stock as a commitment fee at a value of $ 0.5 million. During 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 . The Company terminated the Purchase Agreement with Lincoln Park on February 29, 2024 effective March 1, 2024.
Exercise of Stock Options
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.
Warrant Summary
The following table summarizes the total warrants outstanding at December 31, 2024:
Outstanding
Outstanding
Exercise
as of
as of
Price Per
Expiration
December 31,
New
December 31,
Issue Date
Share
Date
2023
Issuance
Exercised
2024
Private placement warrants
December 2024
$
4.00
5 years from shareholder approval
—
5,031,250
—
5,031,250
Pre-funded warrants
December 2024
$
0.001
5 years from shareholder approval
—
3,247,445
—
3,247,445
—
8,278,695
—
8,278,695
NOTE 9: STOCK BASED COMPENSATION
Stock Options
On May 19, 2020, the Board adopted the 2020 Equity Incentive Plan (“2020 Equity Incentive 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. Awards under the 2020 Plan may be at prices and for terms as determined by the Company’s board of directors and may have vesting requirements as determined by the Board, provided that the exercise price for any stock option must be at least equal to the fair market value (as defined in the 2020 Plan) of a share of the stock on the grant date. Once granted, the exercise price of an option may not be reduced without the approval of the Company’s stockholders, other than under certain limited circumstances such as a stock split or take any other action with respect to a stock option that would be treated as a repricing under the rules and regulations of the Nasdaq Stock Exchange.
Options granted under the 2020 Plan have a maximum term of ten years from the date of grant and generally vest over four years .
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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 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 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 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. 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 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 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.
For the year ended December 31, 2023, the Company recorded incremental stock-based compensation expense of approximately $ 0.3 million pertaining to the modification of stock options in connection with the termination of certain employees that were hired by Cell Ready or transitioned as independent consultants. The modification provided for an acceleration of unvested options, resulting in a change in compensation expense that was immediately recognized. $ 0.2 million is reflected in loss from discontinued operations.
As of December 31, 2024, approximately 1.2 million shares of common stock are available to be issued under the 2020 Plan.
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Stock Options
A summary of the Company’s stock option activity for the years ended December 31, 2024 and December 31, 2023, is as follows:
Weighted Average
Remaining
Weighted Average
Contractual
Number of Shares
Exercise Price
Total Intrinsic Value
Life (in years)
Outstanding as of January 1, 2023
886,173
$
42.90
$
—
7.3
Granted
544,532
1.99
—
5.6
Exercised
( 27,518 )
3.29
Canceled/Expired
( 665,292 )
30.41
—
—
Outstanding as of December 31, 2023
737,895
25.42
$
1,317,000
7.6
Granted
—
—
—
—
Exercised
( 25,602 )
2.43
—
—
Canceled/Expired
( 124,589 )
42.24
—
—
Outstanding as of December 31, 2024
587,704
$
22.85
$
378,000
6.8
Options vested and exercisable
395,492
$
32.86
$
152,000
6.2
The Black-Scholes option pricing model is used to estimate the fair value of stock options granted under the Company’s share-based compensation plans. The weighted average assumptions used in calculating the fair values of stock options that were granted during the years ended December 31, 2024 and 2023, respectively, were as follows:
For the Years Ended
December 31,
2024
2023
Exercise price
$
—
$
1.99
Expected term (years)
—
6.0
Expected stock price volatility
—
%
91
%
Risk-free rate of interest
—
%
4
%
Expected dividend rate
—
%
—
%
The following table sets forth stock-based compensation expenses recorded during the respective periods:
For the Years Ended
December 31,
2024
2023
Stock Compensation expenses:
Research and development
$
15,000
$
338,000
General and administrative
231,000
520,000
Stock compensation in continuing operations
246,000
858,000
Stock compensation in discontinued operations
—
725,000
Total stock compensation expenses
$
246,000
$
1,583,000
At December 31, 2024, the total stock-based compensation cost related to unvested awards not yet recognized was $ 0.2 million. The expected weighted average period compensation costs to be recognized was 1.9 years. Future option grants will impact the compensation expense recognized.
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NOTE 10: GRANT INCOME
CPRIT
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 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.
If restricted cash received from grants in advance of incurring qualifying costs, it is recorded as deferred revenue and recognized as revenue when qualifying costs are incurred. There was no restricted cash recorded as of December 31, 2024 and December 31, 2023. If qualifying grant income is earned in advance of cash received from grants, it is recognized as revenue and recorded as other receivable.
The Company recorded $ 4.4 million and $ 2.7 million of grant income related to the CPRIT grant as revenue for the years ended December 31, 2024 and 2023, respectively. 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).
FDA
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, 2024, the Company had no other receivable recorded with respect to the FDA grant.
SBIR
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 $ 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.
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.
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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.
NOTE 11: 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, 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.
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NOTE 12: RELATED PARTY TRANSACTIONS
The following table sets forth related party transaction expenses recorded for the years ended December 31, 2024 and 2023, respectively.
For the Years Ended
December 31,
2024
2023
Baylor College of Medicine
$
7,000
$
13,000
Cell Ready
5,846,000
1,330,000
Wilson Wolf Manufacturing Corporation
—
277,000
Total Research and development
$
5,853,000
$
1,620,000
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.
Agreements with The Baylor College of Medicine (“BCM”) .
In November 2018, January 2020 and February 2020, the Company entered in Sponsored Research Agreements with BCM, which provided for the conduct of research for the Company by credentialed personnel at BCM’s Center for Cell and Gene Therapy.
In September 2019, May 2020 and July 2021, the Company entered into Clinical Supply Agreements with BCM, which provided for BCM to provide to the Company multi tumor antigen specific products.
In October 2019, the Company entered in a Workforce Grant Agreement with BCM, which provided for BCM to provide to the Company manpower costs of projects for manufacturing, quality control testing and validation run activities.
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.
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.
BCM is also a shareholder of the Company’s common stock.
Purchases from Wilson Wolf .
In 2023, the Company utilized Wilson Wolf for the purchases of cell culture devices. Mr. 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 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).
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. 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.
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NOTE 13: INCOME TAXES
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:
For the Years Ended
December 31,
2024
2023
Deferred Tax Assets
Net Operating Loss Carryforward
$
30,725,000
$
29,352,000
Stock Compensation
1,670,000
2,598,000
Capitalized R&E
7,869,000
7,026,000
Research and Development
733,000
733,000
40,997,000
39,709,000
Less: Valuation Allowance
( 40,997,000 )
( 39,709,000 )
Total Deferred Tax Assets
$
—
$
—
Total Deferred Tax Liabilities
$
—
$
—
Net Deferred Tax Assets/(Liabilities)
$
—
$
—
The Company assesses the likelihood that deferred tax assets will be realized. To the extent that realization is not likely, a valuation allowance is established. 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 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. The federal net operating loss carryforwards of $ 38.4 million, if not utilized, will expire between 2030 and 2037 . The federal net operating loss carryforwards of $ 99.9 million generated in 2018 and thereafter are subject to an 80 % limitation on taxable income, do not expire and will carry forward indefinitely. The 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 $ 16.9 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. 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, 2024, and 2023, 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.
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The Company’s income tax returns for 2021 to 2023 are still open and subject to audit. In addition, net operating losses arising from prior years are also subject to examination at the time they are utilized in future years.
For the years ended December 31, 2024, and 2023, the expected tax expense (benefit) from continuing operations based on the U. S. federal statutory rate is reconciled with the actual tax provision (benefit) as follows:
For the Years Ended December 31,
2024
2023
Percent of
Percent of
Amount
Pretax Loss
Amount
Pretax Loss
U.S. federal statutory rate
$
( 2,243,000 )
21.00
%
$
( 2,948,000 )
21.00
%
State taxes, net of federal benefit
15,000
( 0.14 )
%
( 20,000 )
0.14
%
Tax rate change
( 1,000 )
0.01
%
( 9,000 )
0.06
%
Permanent Differences
- Other permanent differences
27,000
( 0.25 )
%
25,000
( 0.18 )
%
Change in valuation allowance
1,288,000
( 12.06 )
%
( 1,556,000 )
11.08
%
Deferred true-up
953,000
( 8.92 )
%
4,512,000
( 32.14 )
%
Other
11,000
( 0.11 )
%
—
—
Income tax provision/(benefit)
$
50,000
( 0.47 )
%
$
4,000
( 0.04 )
%
The Company recognized approximately $ 50,000 in state tax expense for the year ended December 31, 2024.
ASC 740 prescribes a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. As of December 31, 2024, and 2023, there were no unrecognized tax benefits. The Company recognizes accrued interest and penalties as income tax expense. No amounts were accrued for the payment of interest and penalties at December 31, 2024 and 2023. 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.
NOTE 14: SUBSEQUENT EVENTS
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.
F-25
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.