MRKR 10-Q
Marker Therapeutics, Inc. (MRKR)
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
Commission File Number:
(Name of registrant in its charter)
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(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
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(Address of principal executive offices) | (Zip Code) |
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(Issuer’s telephone number) |
2450 Holcombe Blvd, Suite BCM-A, MS: BCM251 (Former Address) |
(Former name, former address and former fiscal year, if changed since last report) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
| Trading Symbol(s) |
| Name of each exchange on which registered |
The |
Indicate by check mark whether the registrant (1) filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by checkmark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” accelerated filer”, “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ | |
☒ | Smaller reporting company | |||
Emerging growth company | ||||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
The registrant had
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
MARKER THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
| September 30, |
| December 31, | |||
| 2025 | 2024 | ||||
ASSETS | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | | $ | | ||
Restricted cash | | — | ||||
Prepaid expenses and deposits | | | ||||
Other receivables | | | ||||
Total current assets |
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Total assets | $ | | $ | | ||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable and accrued liabilities | $ | | $ | | ||
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Deferred revenue | | — | ||||
Total current liabilities | | | ||||
Total liabilities |
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Stockholders’ equity: |
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Preferred stock, $ | ||||||
Common stock, $ | | | ||||
Additional paid-in capital |
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Accumulated deficit |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity | $ | | $ | | ||
See accompanying notes to these unaudited condensed consolidated financial statements.
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MARKER THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
| For the Three Months Ended |
| For the Nine Months Ended | |||||||||
September 30, |
| September 30, | ||||||||||
| 2025 |
| 2024 |
| 2025 |
| 2024 | |||||
Revenues: | ||||||||||||
Grant income | $ | | $ | | $ | | $ | | ||||
Total revenues |
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Operating expenses: | ||||||||||||
Research and development |
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General and administrative | | | | | ||||||||
Loss on early termination of vendor agreement |
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Total operating expenses |
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Loss from operations |
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Other income: |
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Interest income |
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Other income | — | — | | — | ||||||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
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Net loss per share: |
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Net loss per share | $ | ( | $ | ( | $ | ( | $ | ( | ||||
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Weighted average number of common shares outstanding: | ||||||||||||
Basic | | | | | ||||||||
Diluted | | | | | ||||||||
See accompanying notes to these unaudited condensed consolidated financial statements.
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MARKER THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(UNAUDITED)
For the Three Months Ended September 30, 2025 | ||||||||||||||
Total | ||||||||||||||
Common Stock | Additional Paid- | Accumulated | Stockholders’ | |||||||||||
| Shares |
| Par value |
| in Capital |
| Deficit |
| Equity | |||||
Balance at July 1, 2025 | | $ | | $ | | $ | ( | $ | | |||||
Shares purchased pursuant to ATM agreement | | | | — | | |||||||||
Stock-based compensation | — | — | | — | | |||||||||
Net loss | — | — | — | ( | ( | |||||||||
Balance at September 30, 2025 | | $ | | $ | | $ | ( | $ | | |||||
For the Nine Months Ended September 30, 2025 | ||||||||||||||
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| Total | ||||||||||
Common Stock | Additional Paid- | Accumulated | Stockholders’ | |||||||||||
Shares |
| Par value | in Capital | Deficit | Equity | |||||||||
Balance at January 1, 2025 |
| | $ | | $ | | $ | ( | $ | | ||||
Shares purchased pursuant to ATM agreement | | | | — | | |||||||||
Issuance of common stock from exercise of prefunded warrants | | | — | — | | |||||||||
Stock-based compensation |
| — |
| — |
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| — |
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Net loss | — | — | — | ( | ( | |||||||||
Balance at September 30, 2025 |
| | $ | | $ | | $ | ( | $ | | ||||
For the Three Months Ended September 30, 2024 | ||||||||||||||
Total | ||||||||||||||
Common Stock | Additional Paid- | Accumulated | Stockholders’ | |||||||||||
| Shares |
| Par value |
| in Capital |
| Deficit |
| Equity | |||||
Balance at July 1, 2024 | | $ | | $ | | $ | ( | $ | | |||||
Issuance of common stock from exercise of stock options | | | | — | | |||||||||
Stock-based compensation | — | — | | — | | |||||||||
Net loss | — | — | — | ( | ( | |||||||||
Balance at September 30, 2024 | | $ | | $ | | $ | ( | $ | | |||||
For the Nine Months Ended September 30, 2024 | ||||||||||||||
| Total | |||||||||||||
Common Stock | Additional Paid- | Accumulated | Stockholders’ | |||||||||||
| Shares |
| Par value |
| in Capital |
| Deficit |
| Equity | |||||
Balance at January 1, 2024 |
| | $ | | $ | | $ | ( | $ | | ||||
Shares purchased pursuant to ATM agreement | | | | — | | |||||||||
Issuance of common stock from exercise of stock options | | | | — | | |||||||||
Stock-based compensation | — |
| — |
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| — |
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Net loss |
| — |
| — |
| — |
| ( |
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Balance at September 30, 2024 |
| | $ | | $ | | $ | ( | $ | | ||||
See accompanying notes to these unaudited condensed consolidated financial statements.
3
MARKER THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
For the Nine Months Ended | ||||||
September 30, | ||||||
| 2025 |
| 2024 | |||
Cash Flows from Operating Activities: | ||||||
Net loss | $ | ( | $ | ( | ||
Reconciliation of net loss to net cash used in operating activities: |
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Stock-based compensation | | | ||||
Changes in operating assets and liabilities: |
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Prepaid expenses and deposits |
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Other receivables | | | ||||
Related party payable |
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Accounts payable and accrued expenses | ( | | ||||
Deferred revenue | | — | ||||
Net cash used in operating activities |
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Cash Flows from Financing Activities: |
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Proceeds from issuance of common stock, net |
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Proceeds from exercise of warrants and stock options |
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Net cash provided by financing activities |
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Net decrease in cash, cash equivalents, and restricted cash |
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Cash, cash equivalents, and restricted cash at beginning of the period |
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Cash, cash equivalents, and restricted cash at end of the period | $ | | $ | | ||
See accompanying notes to these unaudited condensed consolidated financial statements.
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MARKER THERAPEUTICS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2025
(Unaudited)
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 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, or tumor targets. MAR-T cells are designed to detect and kill tumor cells expressing those targets to produce a broad spectrum anti-tumor activity. The Company was incorporated in Nevada in 1992 and reincorporated in Delaware in October 2018.
Currently, the Baylor College of Medicine (“BCM”) supplies the Company with MT-601, the Company’s lead Multi-Antigen Recognizing (MAR)-T cell therapy in anticipation of the commencement of the Company’s larger pivotal trial for Lymphoma.
On June 16, 2025, the Company entered into a Statement of Work (the “SOW”) with Cellipont Bioservices (“Cellipont”), a leading cell therapy Contract Development and Manufacturing Organization (“CDMO”), for the manufacturing of MT-601. Pursuant to the SOW, Cellipont will provide technology transfer and cGMP manufacturing services to support the scale-up and production of MT-601 for the Company’s APOLLO study.
NOTE 2: BASIS OF PRESENTATION
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of such interim results.
The results for the unaudited condensed consolidated statement of operations are not necessarily indicative of results to be expected for the year ending December 31, 2025, or for any future interim period. The condensed consolidated balance sheet at December 31, 2024 has been derived from audited financial statements, however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 2024 and notes thereto included in the Company’s annual report on Form 10-K filed on March 31, 2025.
NOTE 3: LIQUIDITY AND FINANCIAL CONDITION
As of September 30, 2025, the Company had cash, cash equivalents, and restricted cash of approximately $
In November 2024, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co. LLC, relating to the sale of shares of its common stock , from time to time, through H.C. Wainwright & Co. LLC 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. 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
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Agreement. H.C. Wainwright & Co. LLC is entitled to compensation under the ATM Agreement at a commission rate equal to
In August 2021, the Company received notice of a Product Development Research award totaling approximately $
In September 2022, the Company received notice from the U.S. Food and Drug Administration (the “FDA”) that it had awarded the Company a $
In May 2023, the Company received notice of a $
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 $
In August 2024, the Company received notice of a $
In August 2024, the Company received another $
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In December 2024, the Company received notice of an additional $
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)
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, cash equivalents, and restricted cash as of September 30, 2025, and taking into consideration the net proceeds received in July and August of 2025 through the sale of Common Stock pursuant to its ATM Agreement with H.C. Wainwright & Co., LLC (see Note 13), the Company anticipates that it will be able to fund its operating expenses and capital expenditure requirements through the third quarter of 2026, assuming no additional grant funds are received, either from new grants or from existing awarded grants. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern.
Management is considering raising additional capital through the issuance of securities and intends to apply for additional grant funds, which could enable the Company to fund its operating expenses and capital expenditure requirements beyond the third 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, of which there can be no assurances.
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; |
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| ● | 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 unaudited condensed 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, high inflation and concerns about an economic recession in the United States or other major markets have resulted in, among other things, volatility in the capital markets that may have the effect of reducing the Company’s ability to access capital, which could in the future negatively affect the Company’s liquidity. In addition, a recession or market correction due to these factors could materially affect the Company’s business and the value of its common stock.
NOTE 4: SIGNIFICANT ACCOUNTING POLICIES
There have been no material changes in the Company’s significant accounting policies to those previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 31, 2025.
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, Restricted Cash, and Credit Risk
The Company considers highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Cash, cash equivalents, and restricted cash at September 30, 2025 consisted of cash and certificates of deposit in institutions in the United States. The Company maintains cash in accounts which are in excess of the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $250,000. As of September 30, 2025, the Company had approximately $
In the event cash is received from grants in advance of incurring qualifying costs, it is recorded as restricted cash and deferred revenue until it is earned and recorded to grant income. As of September 30, 2025, $
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Modification of Stock Options
During the nine months ended September 30, 2025, the Company recorded incremental stock-based compensation expense of $
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 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 product candidates. 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 Company’s summary of significant accounting policies as previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 31, 2025. 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.
Recently Issued Accounting Standards Not Yet Adopted
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“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 consolidated financial position or results of operations upon adoption.
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. The Company does 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.
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Intangibles – Goodwill and Other (Topic 350): Internal-use Software
In September 2025, the FASB issued ASU 2025-06, Intangibles-Goodwill and Other (Topic 350): Internal-use Software, which removes all references to prescriptive and sequential software development stages (referred to as “project stages”) throughout Subtopic 350-40 and requires the capitalization of software costs to begin when 1) management has authorized and committed to funding the software project and 2) it is probable that the project will be completed and the software will be used to perform the function intended. This guidance will be effective for annual reporting periods 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 does not expect the adoption of this guidance to have a material impact on its consolidated financial statements.
Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract
In September 2025, the FASB issued ASU 2025-07, Derivatives and Hedging (Topic 815) and Revenue from Contracts with Customers (Topic 606): Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract. This ASU excludes from derivative accounting non-exchange-traded contracts with underlyings based on operations or activities specific to one of the parties to the contract. This guidance will be effective for annual reporting periods and interim reporting periods beginning after December 15, 2026. Early adoption is permitted. Upon adoption, the guidance can be applied prospectively or retrospectively. The Company does not expect the adoption of this guidance to have a material impact on its consolidated financial statements.
U.S Tax Law Changes
On July 4, 2025, the One Big Beautiful Bill Act (OBBBA) was enacted, introducing significant changes to U.S. tax law, including provisions related to bonus depreciation, interest expense limitations, and the treatment of domestic research and development expenditures.
The Company is currently assessing the potential impact of these changes on its financial statements, including income tax provisions, deferred tax assets and liabilities, and related disclosures under ASC 740. Due to the complexity and scope of the legislation, management has not yet completed its evaluation and is unable to reasonably estimate the financial effects as of the reporting date. The Company will update its disclosures in future reporting periods as the analysis progresses and additional guidance becomes available.
NOTE 5: NET LOSS PER SHARE
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.
The following table sets forth the computation of net loss per share for the three and nine months ended September 30, 2025 and 2024, respectively:
| For the Three Months Ended |
| For the Nine Months Ended | |||||||||
September 30, |
| September 30, | ||||||||||
| 2025 |
| 2024 |
| 2025 |
| 2024 | |||||
Numerator: | ||||||||||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
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Denominator: |
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Weighted average common shares outstanding, basic |
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Weighted average common shares outstanding, diluted |
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Net loss per share: |
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Loss from per share, basic and diluted | $ | ( | $ | ( | $ | ( | $ | ( | ||||
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The following securities, rounded to the nearest thousand, were not included in the diluted net loss per share calculation because their effect was anti-dilutive for the periods presented:
For the Nine Months Ended | ||||
September 30, | ||||
| 2025 |
| 2024 | |
Common stock options | |
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Common stock purchase warrants | |
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Potentially dilutive securities | |
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NOTE 6: 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 $
The Company recorded $
The Company recorded approximately $
The Company recorded approximately $
The Company recorded $
The Company recorded approximately $
NOTE 7: ACCOUNTS PAYABLE, ACCRUED LIABILITIES AND RELATED PARTY PAYABLE
Accounts payable, accrued liabilities, and related party payable consist of the following as of September 30, 2025 and December 31, 2024, respectively:
| September 30, |
| December 31, | |||
2025 | 2024 | |||||
Accounts payable | $ | | $ | | ||
Compensation and benefits |
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Professional fees | | | ||||
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Tax fees |
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Other |
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Total accounts payable, accrued liabilities and related party payable | $ | | $ | | ||
The $
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NOTE 8: STOCKHOLDERS’ EQUITY
Common Stock Transactions
Issuance of Common Stock Pursuant to ATM Agreement
During the nine months ended September 30, 2025, the Company sold
During the nine months ended September 30, 2024, the Company sold
Exercise of Stock Options
During the nine months ended September 30, 2024, certain outstanding options were exercised for
Warrant Summary
The following table summarizes the total warrants outstanding at September 30, 2025:
Outstanding | Outstanding | ||||||||||||||
Exercise | as of | as of | |||||||||||||
Price Per | Expiration | December 31, | New | September 30, | |||||||||||
| Issue Date |
| Share |
| Date |
| 2024 |
| Issuance |
| Exercised |
| 2025 | ||
Private placement warrants |
| December 2024 | $ | |
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Pre-funded warrants |
| December 2024 | $ | |
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NOTE 9: STOCK-BASED COMPENSATION
Stock Options
2025 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
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A summary of the Company’s stock option activity for the nine months ended September 30, 2025 is as follows:
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| Weighted Average | |||||||
Remaining | ||||||||||
Weighted Average | Contractual | |||||||||
| Number of Shares |
| Exercise Price |
| Total Intrinsic Value |
| Life (in years) | |||
Outstanding as of December 31, 2024 |
| | $ | | $ | | ||||
Granted | | | — | — | ||||||
Canceled/Expired |
| ( | | — | — | |||||
Outstanding as of September 30, 2025 |
| | $ | | $ | — | ||||
Options vested and exercisable |
| | $ | | $ | — | ||||
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 nine months ended September 30, 2025 were as follows:
| For the Nine Months |
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Ended September 30, 2025 |
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Exercise price | $ | | ||
Expected term (years) |
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Expected stock price volatility |
| | % | |
Risk-free rate of interest |
| | % | |
Expected dividend rate |
| | % | |
The following table sets forth stock-based compensation expenses recorded during the respective periods:
| For the Three Months Ended |
| For the Nine Months Ended | |||||||||
September 30, |
| September 30, | ||||||||||
| 2025 |
| 2024 |
| 2025 |
| 2024 | |||||
Stock Compensation expenses: |
|
|
|
|
|
|
| |||||
Research and development | $ | — | $ | | $ | | $ | | ||||
General and administrative |
| |
| |
| |
| | ||||
Total stock compensation expenses | $ | | $ | | $ | | $ | | ||||
During the nine months ended September 30, 2025, the Company recorded incremental stock-based compensation expense of $
As of September 30, 2025, the total stock-based compensation cost related to unvested awards not yet recognized was $
NOTE 10: GRANT INCOME
There was $
CPRIT
In August 2021, the Company received notice of a Product Development Research award totaling approximately $
13
The Company recorded $
In December 2024, the Company received notice of an additional $
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 $
NIH SBIR
In May 2023, the Company announced it had received a $
In August 2024, the Company received notice of a $
In August 2024, the Company received notice of another $
In June 2024, the Company received notice of a $
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 $
14
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
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 $
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 legal proceedings that we believe could have a material adverse effect on our business, operating results or financial condition.
NOTE 12: RELATED PARTY EXPENSES
The following table sets forth related party transaction expenses recorded for the three and nine months ended September 30, 2025 and 2024, respectively.
For the Three Months Ended |
| For the Nine Months Ended | ||||||||||
September 30, |
| September 30, | ||||||||||
| 2025 |
| 2024 |
| 2025 |
| 2024 | |||||
Baylor College of Medicine | $ | | $ | — | $ | | $ | | ||||
Cell Ready | | | | | ||||||||
Wilson Wolf Manufacturing Corporation | | — | | — | ||||||||
Total Research and development | $ | |
| $ | | $ | |
| $ | | ||
$
15
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. On April 1, 2025, the Company sighed Amendment #1 to the Sponsored Research and Product Development Agreement with BCM to perform research on “Controlling Tumor Immune Escape in Pancreatic Cancer using a Dual T-Cell Product Strategy.”
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 into 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 and Laboratory Service Agreement with BCM, pursuant to which BCM conducts clinical trials for the Company and testing of Marker’s product candidates to develop an optimized potency assay.
BCM is also a shareholder of the Company’s common stock.
During the three and nine months ended September 30, 2025, the Company incurred $
Purchases from Wilson Wolf
In 2024, the Company utilized Wilson Wolf for the purchases of cell culture devices. Mr. John Wilson is a former director of the Company and is serving as the CEO of Wilson Wolf Manufacturing Corporation.
During the three and nine months ended September 30, 2025, the Company incurred approximately $
Purchases from Cell Ready, LLC
The Company has utilized Cell Ready, LLC for clinical manufacturing supply and product development. On February 22, 2024, the Company entered into a
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 $
16
NOTE 13: SUBSEQUENT EVENTS
Appointment of New Director
On October 31, 2025, the board of directors of the Company (the “Board”) appointed Ms. Kathryn Penkus Corzo to the Company’s Board, effective November 1, 2025. In connection with the appointment of Ms. Corzo to the Company’s Board and pursuant to the Company’s current non-employee directors compensation program, and pursuant to the Company’s 2020 Equity Incentive Plan, as amended (the “2020 Plan”) as applied to new, non-employee directors, the Company also granted Ms. Corzo
Chief Executive Officer Stock Option Award.
On October 31, 2025, the Compensation Committee and Board approved a discretionary award of
17
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, that involve risks and uncertainties. All statements other than statements relating to historical matters including statements to the effect that we “believe”, “expect”, “anticipate”, “plan”, “target”, “intend” and similar expressions should be considered forward-looking statements. Our actual results could differ materially from those discussed in the forward-looking statements as a result of a number of important factors, including factors discussed in this section and elsewhere in this Quarterly Report on Form 10-Q, and the risks discussed in our other filings with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis, judgment, belief, or expectation only as the date hereof. We assume no obligation to update these forward-looking statements to reflect events or circumstance that arise after the date hereof.
As used in this quarterly report: (i) the terms “we”, “us”, “our”, “Marker” and the “Company” mean Marker Therapeutics, Inc. and its wholly owned subsidiaries, Marker Cell Therapy, Inc. and GeneMax Pharmaceuticals Inc. which wholly owns GeneMax Pharmaceuticals Canada Inc., unless the context otherwise requires; (ii) “SEC” refers to the Securities and Exchange Commission; (iii) “Securities Act” refers to the Securities Act of 1933, as amended; (iv) “Exchange Act” refers to the Securities Exchange Act of 1934, as amended; and (v) all dollar amounts refer to United States dollars unless otherwise indicated.
The following should be read in conjunction with our unaudited condensed consolidated interim financial statements and related notes included in this Quarterly Report on Form 10-Q.
Company Overview
We are a clinical-stage immuno-oncology company specializing in the development of novel T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Harnessing millions of years of immunologic evolution, Marker’s Multi-Antigen Recognizing (“MAR”)-T cell technology is designed to recognize and kill highly heterogeneous tumors without the need for genetic modifications. This approach selectively expands natural tumor-specific T cells from a patient’s/donor’s blood that are capable of recognizing a broad range of tumor associated antigens, or TAAs. Unlike other T cell therapies, MAR-T cells are able to recognize hundreds of different epitopes within up to six tumor-specific antigens to produce broad spectrum anti-tumor activity. Targeting multiple antigens simultaneously exploits the natural capacity of T cells to recognize and kill tumor targets via native T cell receptors (“TCR”), while limiting tumor adaptation/escape by antigen-negative selection or antigen down-regulation. When infused into a patient with cancer, MAR-T cells are designed to recognize and kill cancer cells expressing the TAA.
We licensed the underlying technology for MAR-T cell therapy from Baylor College of Medicine, or BCM, in March 2018. BCM had utilized the therapy in seven exploratory clinical trials. In these studies, BCM treated over 150 patients suffering from a variety of cancers including lymphoma, multiple myeloma, acute myeloid leukemia, or AML, acute lymphoblastic leukemia, or ALL, pancreatic cancer, breast cancer and various sarcomas. In those studies, BCM saw evidence of clinical benefit, expansion of infused cells, and decreased toxicity compared to other cellular therapies.
We are advancing two product candidates for 3 clinical indications as part of our MAR-T cell program for:
| ● | Autologous MAR-T cell product candidate for the treatment of lymphoma and pancreatic cancer (MT-601) |
| ● | Off-the-Shelf (OTS) product candidate in various indications (e.g., MT-401-OTS) |
18
We do not genetically engineer our MAR-T cells and we believe that our product candidates are superior to T cells engineered with chimeric antigen receptors, or CAR-T, for several reasons including:
| ● | Multiple targets → enhanced tumoricidal effect→ minimized tumor immune escape |
| ● | Clinical safety → no treatment-related side effects, including immune effector cell-associated neurotoxicity syndrome (“ICANS”) or other severe adverse effects (“SAEs”), were attributed to the use of MAR-T cells to date |
| ● | Non-genetically engineered T cell → selective expansion of tumor-specific T cells from a patient’s or donor’s blood capable of recognizing a broad range of tumor antigens→ no risk of mutagenesis and reduced manufacturing complexity → lower cost |
For these reasons, we believe our endogenous T cell receptor-based product candidates may provide meaningful clinical benefit and safety to patients with both hematological and solid tumors.
We believe that the simplicity of our manufacturing process allows additional modifications to expand MAR-T cell recognition of cancer targets. For example, we are assessing the potential of combining MAR-T cell product candidates with other products.
On August 26, 2025, we issued a press release providing an update on the progress and clinical observations from the Phase 1 APOLLO study, with a data cutoff date of June 2025. The Phase 1 APOLLO study is investigating MT-601, a MAR-T cell product candidate, in patients with lymphoma who have relapsed after anti-CD19 CAR-T cell therapy or for whom anti-CD19 CAR-T cells are not an option. In this update, clinical data was available for a total of 24 B-cell lymphoma patients from 7 clinical sites across the United States, including 15 patients with Non-Hodgkin Lymphoma (“NHL”) and 9 patients with Hodgkin Lymphoma (“HL”). At the time of the data cutoff, 12 NHL and 9 HL patients have been assessed. Study participants showed objective responses and a favorable safety profile with and without lymphodepletion.
Key findings from the APOLLO study include:
| ● | Safety – The dose escalation portion of the study tested doses ranging from 100x106-400x106 cells. Infusion of MT-601 was well tolerated in all study participants, with no observation of immune-effector cell associated neurotoxicity syndrome (“ICANS”) and two reported Grade 1 cytokine release syndrome (“CRS”) events (fever; no treatment was required). No dose limiting toxicities (“DLTs”) have been reported to date. No change in DLTs or ICANS was observed between patients treated with and without lymphodepletion. |
| ● | Efficacy and Duration of Response – Eight out of 12 NHL patients achieved objective responses (66%), with 6 patients demonstrating complete response (“CR”) as best response (50%). Durable responses were observed (range 3-24 months) with 5 NHL patients showing continued response over 6 months, including 3 patients with over 12 months durability. Seven out of 9 HL patients had objective responses (78%), with 1 patient demonstrating CR (11%) highlighting the versatility of MT-601 across multiple histologies. |
19
Pipeline
Our clinical-stage pipeline is set forth below:
Manufacturing
Our manufacturing process was originally developed at Baylor College of Medicine, where we initially conducted our clinical trials. We continue to contract and collaborate with BCM and others to perform a wide variety of services to ensure the continuation of our research and development efforts, with the goal of optimizing our manufacturing process, product quality and commercial scalability.
On February 22, 2024, we 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. Cell Ready, which is owned by one of our former directors, Mr. John Wilson, is a contract development and manufacturing organization (“CDMO”). On March 27, 2025, we mutually agreed with Cell Ready to terminate the MSA. In connection therewith, we and Cell Ready entered into a settlement and release agreement pursuant to which we paid Cell Ready approximately $453,000 and we and Cell Ready provided one another mutual releases of all claims associated with any and all agreements between Marker and Cell Ready.
While BCM continues to supply us with products, as we continue our clinical trials, in anticipation of the commencement of our larger pivotal trial for Lymphoma in 2026, as well as the eventual need for commercial scale production, on June 16, 2025, Company entered into a Statement of Work (the “SOW”) with Cellipont Bioservices (“Cellipont”), a leading cell therapy Contract Development and Manufacturing Organization (CDMO), for the manufacturing of MT-601, the Company’s lead Multi-Antigen Recognizing (MAR)-T cell therapy. Pursuant to the SOW, Cellipont will provide technology transfer and cGMP manufacturing services to support the scale-up and production of MT-601 for the Company’s APOLLO study.
However, there is no guarantee that we will or have properly estimated our required manufacturing capacities or that the third parties on which we rely to manufacture our products will be able or willing to perform on our proposed timelines or to meet our manufacturing demands, if at all. If any of our third-party vendors experience disruptions, or otherwise cease or substantially reduce the amount of products they are willing to supply us, our business and operations could be adversely affected.
During the three and nine months ended September 30, 2025, we incurred $0.1 million and $1.1 million in expenses related to Cell Ready services and manufacturing costs, respectively (three and nine months ended September 30, 2024 - $1.2 million and $3.1 million, respectively). During the nine months ended September 30, 2025, we paid $2.6 million related to Cell Ready invoices received (three and nine months ended September 30, 2024 - $0.5 million and $3.4 million, respectively). During the three and nine months ended September 30, 2025, we incurred $0.4 million and $3.0 million, respectively, in expenses related to BCM services and manufacturing costs. BCM expenses were $6,000 during the three and nine months ended September 30, 2024. During the three and nine months ended
20
September 30, 2025, we paid approximately $4,000 and $2.7 million related to BCM invoices received, respectively. During the three and nine months ended September 30, 2025, we incurred $0.1 million and $0.3 million, respectively, in expenses related to Cellipont services and manufacturing costs. No Cellipont expenses were incurred during the three or nine months ended September 30, 2024. During the three and nine months ended September 30, 2025, we paid nil and $0.4 million related to Cellipont invoices received, respectively.
Recent Developments
On June 16, 2025, Company entered into a Statement of Work (the “SOW”) with Cellipont Bioservices, a leading cell therapy Contract Development and Manufacturing Organization (“CDMO”), for the manufacturing of MT-601, the Company’s lead MAR-T cell product candidate. Pursuant to the SOW, Cellipont will provide technology transfer and cGMP manufacturing services to support the scale-up and production of MT-601 for the Company’s APOLLO study.
Between July 17 and 21, 2025, the Company sold 1,624,075 shares of common stock pursuant to our ATM Agreement, with H.C. Wainwright & Co. LLC, for net proceeds of $4.5 million, after deducting agent commissions, at an average price per share of $2.87 per share.
On August 26, 2025, the Company sold 3,734,217 shares of common stock pursuant to the ATM Agreement with H.C. Wainwright & Co., LLC for net proceeds of $5.4 million, after deducting agent commissions, at an average price of $1.48 per share.
On October 6, 2025, the Company announced that the first patient has been treated in the Off-the-Shelf (“OTS”) program, with encouraging preliminary safety data. The OTS program has the potential to provide a fast treatment option for patients with rapidly progressing diseases. The OTS product will be initially investigated in patients with acute myeloid leukemia (“AML”) or myelodysplastic syndromes (“MDS”), with the potential to be expanded to other indications.
Results of Operations
In this discussion of our results of operations and financial condition, amounts in financial tables, other than per-share amounts, have been rounded to the nearest thousand.
Comparison of the Three months Ended September 30, 2025 and 2024
The following table summarizes the results of our continuing operations for the three months ended September 30, 2025 and 2024:
For the Three Months Ended | ||||||||||||
September 30, |
|
| ||||||||||
| 2025 |
| 2024 |
| Change |
| ||||||
Revenues: |
|
|
|
|
|
|
| |||||
Grant income | $ | 1,233,000 | $ | 1,926,000 | $ | (693,000) |
| (36) | % | |||
Total revenues |
| 1,233,000 |
| 1,926,000 |
| (693,000) |
| (36) | % | |||
Operating expenses: |
|
|
|
| ||||||||
Research and development |
| 2,346,000 |
| 3,471,000 |
| (1,125,000) |
| (32) | % | |||
General and administrative |
| 1,024,000 |
| 855,000 |
| 169,000 |
| 20 | % | |||
Total operating expenses |
| 3,370,000 |
| 4,326,000 |
| (956,000) |
| (22) | % | |||
Loss from operations |
| (2,137,000) |
| (2,400,000) |
| 263,000 |
| (11) | % | |||
Other income (expenses): |
|
|
|
|
|
|
| |||||
Interest income |
| 138,000 |
| 92,000 |
| 46,000 |
| 50 | % | |||
Loss from continuing operations | $ | (1,999,000) | (2,308,000) | $ | 309,000 |
| (13) | % | ||||
Revenue
We did not generate any revenue during the three months ended September 30, 2025 and 2024, respectively, from the sales or licensing of our product candidates.
21
In August 2021, we received notice of a Product Development Research award totaling approximately $13.1 million from the Cancer Prevention and Research Institute of Texas (“CPRIT”) to support the clinical investigation of MT-401 as an Off-the-Shelf (“OTS”) product in patients with Acute Myeloid Leukemia (“AML”) (the “CPRIT AML Grant”). During the three months ended September 30, 2025 and 2024, we recognized $0.2 million and $0.9 million of revenue, respectively, associated with the CPRIT AML Grant.
In September 2022, we received notice from the FDA that it had awarded us 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 (the “FDA Grant”). During the three months ended September 30, 2025 and 2024, we recognized approximately $0.01 million and $0.02 million of revenue, respectively associated with the FDA Grant.
In May 2023, we received notice of a $2.0 million grant from the National Institutes of Health (“NIH”) 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 (the “SBIR AML Grant”). During the three months ended September 30, 2025 and 2024, we recognized $0.2 million and $0.3 million of revenue associated with the SBIR AML 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, we received notice of a $2.0 million grant over a 2-year period from the NIH SBIR program to support control over tumor immune escape in pancreatic cancer using a dual T cell product strategy (the “Decoy Grant”). During the three months ended September 30, 2025 and 2024, we recognized approximately $0.1 million and nil of revenue associated with the Decoy Grant, respectively.
In August 2024, we received notice of an additional $2.0 million grant from the NIH 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 (the “SBIR NHL Grant”). During the three months ended September 30, 2025 and 2024, we recognized $0.6 million and $0.7 million of revenue associated with the SBIR NHL Grant, respectively.
In August 2024, we received another $2.0 million grant from the NIH SBIR program to support the advancement of MT-601 in patients with pancreatic cancer (the “PANACEA Grant”). During the three months ended September 30, 2025 and 2024, we recognized approximately $0.2 million and nil of revenue associated with the PANACEA Grant, respectively.
In December 2024, we 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 (the “CPRIT Pancreatic Grant”). The Company recorded no grant income related to this grant for the three months ended September 30, 2025. As of September 30, 2025, $1.4 million was recorded as restricted cash and deferred revenue on the Company’s condensed consolidated balance sheet. The CPRIT Pancreatic Grant and the CPRIT AML Grant are subject to certain revenue-sharing arrangements, see Note 11 to the accompanying condensed consolidated financial statements for further information.
Operating Expenses
Operating expenses incurred during the three months ended September 30, 2025 were $3.4 million compared to $4.3 million during the same period ended September 30, 2024.
Significant changes and expenditures in operating expenses are outlined as follows:
Research and Development Expenses
Research and development expenses decreased by 32% to $2.3 million for the three months ended September 30, 2025, compared to $3.5 million for the three months ended September 30, 2024.
The decrease of $1.2 million in 2025 was primarily attributable to the following:
| ● | decrease of $1.5 million in clinical trial expenses, offset by |
| ● | increase of $0.3 million in clinical consulting and other expenses. |
22
General and Administrative Expenses
General and administrative expenses increased by 20% to $1.0 million for the three months ended September 30, 2025, compared to $0.9 million during the same period ended September 30, 2024.
The increase of $0.1 million in 2025 was primarily attributable to headcount-related expenses.
Other Income (Expense)
Interest Income
Interest income was $0.1 million for the three months ended September 30, 2025 and 2024, and was attributable to interest income relating to funds that are held in U.S. Treasury notes and U.S. government agency-backed securities.
Net Loss
The decrease in our net loss during the three months ended September 30, 2025 compared to the three months ended September 30, 2024 was primarily due to cost decreases in our research and development activities. We anticipate that we will continue to incur net losses in the future as we continue to invest in research and development activities, including clinical development of our MAR-T cell product candidates.
Comparison of the Nine months Ended September 30, 2025 and 2024
The following table summarizes the results of our continuing operations for the nine months ended September 30, 2025 and 2024:
| For the Nine Months Ended |
|
|
|
|
| ||||||
September 30, |
|
| ||||||||||
| 2025 |
| 2024 |
| Change |
| ||||||
Revenues: | ||||||||||||
Grant income | $ | 2,443,000 | $ | 4,339,000 | $ | (1,896,000) | (44) | % | ||||
Total revenues |
| 2,443,000 |
| 4,339,000 |
| (1,896,000) |
| (44) | % | |||
Operating expenses: |
|
|
|
|
| |||||||
Research and development |
| 9,658,000 |
| 8,382,000 |
| 1,276,000 |
| 15 | % | |||
General and administrative |
| 3,338,000 |
| 3,215,000 |
| 123,000 |
| 4 | % | |||
Loss on early termination of vendor agreement | 453,000 | — | 453,000 | — | % | |||||||
Total operating expenses |
| 13,449,000 |
| 11,597,000 |
| 1,852,000 |
| 16 | % | |||
Loss from operations |
| (11,006,000) |
| (7,258,000) |
| (3,748,000) |
| 52 | % | |||
Other income (expenses): |
|
|
|
|
|
|
| |||||
Interest income |
| 429,000 |
| 363,000 |
| 66,000 |
| 18 | % | |||
Other income | 117,000 | — | 117,000 | — | % | |||||||
Loss from continuing operations | $ | (10,460,000) | (6,895,000) | $ | (3,565,000) |
| 52 | % | ||||
Revenue
We did not generate any revenue during the nine months ended September 30, 2025 and 2024, respectively, from the sales or licensing of our product candidates.
In August 2021, we received notice of a Product Development Research award totaling approximately $13.1 million from the Cancer Prevention and Research Institute of Texas (“CPRIT”) to support the clinical investigation of MT-401 as an Off-the-Shelf (OTS) product in patients with Acute Myeloid Leukemia (“AML”) (the “CPRIT AML Grant”). During the nine months ended September 30, 2025 and 2024, we recognized $0.7 million and $2.4 million of revenue, respectively, associated with the CPRIT AML Grant.
In September 2022, we received notice from the FDA that it had awarded us 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 (the “FDA Grant”). During the nine
23
months ended September 30, 2025 and 2024, we recognized $0.1 million and $0.5 million of revenue, respectively associated with the FDA Grant.
In May 2023, we received notice of a $2.0 million grant from the National Institutes of Health (“NIH”) 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 (the “SBIR AML Grant”). During the nine months ended September 30, 2025 and 2024, we recognized $0.3 million and $0.7 million of revenue associated with the SBIR AML 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 NIH SBIR program to support control over tumor immune escape in pancreatic cancer using a dual T cell product strategy (the “Decoy Grant”). During the nine months ended September 30, 2025 and 2024, we recognized approximately $0.3 million and nil of revenue associated with the Decoy Grant, respectively.
In August 2024, the Company received notice of an additional $2.0 million grant from the NIH 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 (the “SBIR NHL Grant”). During the nine months ended September 30, 2025 and 2024, we recognized $0.6 million and $0.7 million of revenue associated with the SBIR NHL Grant, respectively.
In August 2024, the Company received another $2.0 million grant from the NIH SBIR Program to support the advancement of MT-601 in patients with pancreatic cancer (the “PANACEA Grant”). During the nine months ended September 30, 2025 and 2024, we recognized approximately $0.2 million and nil of revenue associated with the PANACEA Grant, respectively.
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 (the “CPRIT Pancreatic Grant”). The Company recorded $0.2 million of grant income related to this grant for the nine months ended September 30, 2025. As of September 30, 2025, $1.4 million was recorded as restricted cash and deferred revenue on the Company’s condensed consolidated balance sheet. The CPRIT Pancreatic Grant and the CPRIT AML Grant are subject to certain revenue-sharing arrangements, see Note 11 to the accompanying financial statements for further information.
Operating Expenses
Operating expenses incurred during the nine months ended September 30, 2025 were $13.4 million compared to $11.6 million during the same period ended September 30, 2024.
Significant changes and expenditures in operating expenses are outlined as follows:
Research and Development Expenses
Research and development expenses increased by 15% to $9.7 million for the nine months ended September 30, 2025, compared to $8.4 million for the nine months ended September 30, 2024.
The increase of $1.3 million in 2025 was primarily attributable to the following:
| ● | increase of $0.6 million in clinical consulting expenses and other expenses, |
| ● | increase of $0.4 million in clinical trial expenses, |
| ● | increase of $0.2 million process development costs, and |
| ● | increase of $0.1 million in headcount-related expenses. |
24
General and Administrative Expenses
General and administrative expenses increased by 4% to $3.3 million for the nine months ended September 30, 2025, compared to $3.2 million during the same period ended September 30, 2024.
The increase of $0.1 million in 2025 was primarily attributable to higher headcount-related expenses and higher legal and professional fees.
Other Income (Expense)
Interest Income
Interest income was $0.4 million for the nine months ended September 30, 2025 and 2024, and was attributable to interest income relating to funds that are held in U.S. Treasury notes and U.S. government agency-backed securities.
Other Income
Other income was $0.1 million and nil for the nine months ended September 30, 2025 and 2024, respectively, and was attributable to a state sales tax rebate from 2022.
Net Loss
The increase in our net loss during the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 was primarily due to cost increases in our research and development activities and the loss on termination of the Cell Ready MSA, as well as lower grant income. We anticipate that we will continue to incur net losses in the future as we continue to invest in research and development activities, including clinical development of our MAR-T cell product candidates.
Liquidity and Capital Resources
We have not generated any revenues from the sales or licensing of our product candidates since inception and only have limited revenue associated with grants to fund research. We have financed our operations primarily through public and private offerings of our stock and debt including warrants and the exercise thereof, as well as grants.
Based on our lack of recurring revenues, anticipated uses of cash and historical recurring cash losses from operating activities, and cash, cash equivalents, and restricted cash as of September 30, 2025, and taking into consideration the net proceeds received in July and August of 2025 through the sale of Common Stock pursuant to its ATM Agreement with H.C. Wainwright & Co., LLC, we anticipate that we will be able to fund our operating expenses and capital expenditure requirements through the third quarter of 2026, assuming no additional grant funds are received, either from new grants or from existing awarded grants. We are considering raising additional capital through the issuance of common shares and intend to apply for additional grant funds, which could enable us to fund our operating expenses and capital expenditure requirements beyond the third 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. This estimate is subject to our ability to effectively manage our costs, raise additional capital, and receive additional grant funds, of which there can be no assurance.
Cash and Working Capital
The following table sets forth our cash, cash equivalents, restricted cash, and working capital as of September 30, 2025 and December 31, 2024:
| September 30, |
| December 31, | |||
2025 | 2024 | |||||
Cash, cash equivalents, and restricted cash | $ | 18,943,000 | $ | 19,192,000 | ||
Working capital | $ | 18,389,000 | $ | 18,558,000 | ||
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Cash Flows
The following table summarizes our cash flows for the nine months ended September 30, 2025 and 2024:
For the Nine Months Ended | ||||||
September 30, | ||||||
| 2025 |
| 2024 | |||
Net cash provided by (used in): |
|
| ||||
Operating activities | $ | (10,113,000) | $ | (6,207,000) | ||
Investing activities | — | — | ||||
Financing activities | 9,864,000 | 95,000 | ||||
Net decrease in cash, cash equivalents, and restricted cash | $ | (249,000) | $ | (6,112,000) | ||
Operating Activities
Net cash used in operating activities during the nine months ended September 30, 2025 was $10.1 million. The use of cash primarily related to our net loss of $10.5 million, offset by $0.4 million of non-cash stock-based compensation.
Net cash used in operating activities from continuing operations during the nine months ended September 30, 2024 was $6.2 million. The use of cash primarily related to our net loss from continuing operations of $6.9 million offset by a $0.5 million increase from changes in assets and liabilities and a $0.2 million increase from stock-based compensation.
Financing Activities
Net cash provided by financing activities was $9.9 million during the nine months ended September 30, 2025 due to net proceeds from the sale of common stock and the net proceeds from the exercise of warrants. Net cash provided by financing activities was $0.1 million during the nine months ended September 30, 2024 due to the net proceeds from the sale of common stock and the exercise of stock options.
Future Capital Requirements
To date, we have not generated any revenues from the commercial sale of approved drug products, and we do not expect to generate substantial revenue for at least the next several years. If we fail to complete the development of our product candidates in a timely manner or fail to obtain their regulatory approval, our ability to generate future revenue will be compromised. We do not know when, or if, we will generate any revenue from our product candidates, and we do not expect to generate significant revenue unless and until we obtain regulatory approval of, and commercialize, our product candidates. Assuming the Company can continue to raise additional capital and obtain ongoing grant funding, of which there can be no assurances, we expect our expenses to increase in connection with our ongoing activities, particularly if we are able to expand patient enrollment as we continue the research and development of our product candidates and if we are able to successfully commence our pivotal trial for lymphoma, of which there can be no assurances. In addition, if we obtain approval for any of our product candidates, of which there can be no assurances, we expect to incur significant commercialization expenses related to sales, marketing, manufacturing and distribution. We anticipate that we will need substantial additional funding in connection with our continuing operations, of which there can be no assurances. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.
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 in patients with AML. Through the date of this filing, the Company has received $11.8 million of funds from the CPRIT AML Grant. The Company recorded $0.2 million and $0.7 million of grant income related to the CPRIT grant as revenue during the three and nine months ended September 30, 2025, respectively, and as of September 30, 2025, the Company had a grant income receivable balance of $0.6 million for this grant.
On September 13, 2022, the Company received notice from the FDA that it had awarded the Company a $2.0 million grant from the FDA’s Orphan Products Grant program to support the clinical investigation of MT-401 for the treatment of post-transplant AML. Through the date of this filing, the Company has received $1.2 million from the FDA Grant. The Company recorded approximately
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$0.01 million and $0.1 million of grant income related to the FDA Grant as revenue during the three and nine months ended September 30, 2025, and as of September 30, 2025, the Company had approximately $0.01 million of grant income receivable balance for this grant.
In May 2023, the Company announced that it had received a $2.0 million grant from the National Institutes of Health (“NIH”) 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 $1.5 million from the SBIR AML Grant. The Company recorded $0.2 million and $0.3 million of grant income from the SBIR AML Grant as revenue during the three and nine months ended September 30, 2025, respectively, and as of September 30, 2025, the Company had a grant income receivable balance of $0.2 million for this 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 NIH SBIR program 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 $0.3 million from the NIH for the Decoy Grant. The Company recorded $0.1 million and $0.3 million of grant income related to the Decoy Grant as revenue during the three and nine months ended September 30, 2025, respectively, and as of September 30, 2025, the Company had a grant income receivable balance of approximately $0.02 million for this grant.
In August 2024, the Company received notice of a $2.0 million grant from the NIH 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 $1.2 million of funds from the SBIR NHL Grant. The Company recorded $0.6 million grant income related to the SBIR NHL Grant as revenue for the three and nine months ended September 30, 2025, and as of September 30, 2025, the Company had a grant income receivable balance of $0.6 million for this grant.
In August 2024, the Company received another $2.0 million grant from the NIH 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 $0.2 million of funds from the PANACEA Grant. The Company recorded approximately $0.2 million of grant income related to this grant as revenue for the three and nine months ended September 30, 2025, and as of September 30, 2025, the Company had a grant income receivable balance of $0.2 million for this 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. As of the date of this filing, the Company has received $1.5 million of funds related to this grant. The Company recorded nil and $0.2 million of grant income related to this grant as revenue for the three and nine months ended September 30, 2025, respectively. As of September 30, 2025, $1.4 million was recorded as restricted cash and deferred revenue on the Company’s condensed consolidated balance sheet. The CPRIT Pancreatic Grant and the CPRIT AML Grant are subject to certain revenue-sharing arrangements, see Note 11 to the accompanying financial statements for further information.
As discussed further below, between July 17 and 21, 2025, the Company sold 1,624,075 shares of common stock pursuant to our ATM Agreement with H.C. Wainwright & Co., LLC for net proceeds of $4.5 million, after deducting agent commissions, at an average price of $2.87 per share. On August 26, 2025, the Company sold an additional 3,734,217 shares of common stock pursuant to the ATM Agreement with H.C. Wainwright & Co., LLC for net proceeds of $5.4 million, after deducting agent commissions, at an average price of $1.48 per share.
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As of September 30, 2025, we had working capital of $18.4 million, compared to working capital of $18.6 million as of December 31, 2024. Operating expenses incurred during the three and nine months ended September 30, 2025 were $3.4 million and $13.4 million, respectively, compared to $4.3 million and $11.6 million during the equivalent prior year periods, respectively. Based on our lack of recurring revenues, anticipated uses of cash and historical recurring cash losses from operating activities, and cash, cash equivalents, and restricted cash as of September 30, 2025, and taking into consideration the net proceeds received in July and August of 2025 through the sale of Common Stock pursuant to its ATM Agreement with H.C. Wainwright & Co., LLC, we anticipate that we will be able to fund our operating expenses and capital expenditure requirements through the third quarter of 2026, assuming no additional grant funds are received, either from new grants or from existing awarded grants. We are considering raising additional capital through the issuance of securities and intend to apply for additional grant funds, which could enable us to fund our operating expenses and capital expenditure requirements beyond the third 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. This estimate is subject to our ability to effectively manage our costs, raise additional capital, and receive additional grant funds. Our assumptions may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Furthermore, our operating plan may change, and we 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 our product candidates and the extent to which we may enter into additional collaborations with third parties to participate in their development and commercialization, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical trials. Our future funding requirements will depend on many factors, as we:
| ● | initiate or continue clinical trials of our product candidates; |
| ● | continue the research and development of our product candidates and seek to discover additional product candidates; seek regulatory approvals for our product candidates if they successfully complete clinical trials; |
| ● | continue development of our manufacturing capabilities; |
| ● | establish sales, marketing and distribution infrastructure and scale-up manufacturing capabilities to commercialize any product candidates that may receive regulatory approval; |
| ● | evaluate strategic transactions we may undertake; and |
| ● | enhance operational, financial and information management systems and hire additional personnel, including personnel to support development of our product candidates and, if a product candidate is approved, our commercialization efforts. |
Because all of our product candidates are in the early stages of clinical and preclinical development and the outcome of these efforts is uncertain, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of product candidates or whether, or when, we may achieve profitability. Until such time, if ever, that we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity or debt financings and collaboration arrangements.
We plan to continue to fund our operations and capital funding needs through equity and/or debt financing. We may also consider new collaborations or selectively partner our technology. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our stockholders will be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of our existing stockholders’ common stock. The incurrence of indebtedness would result in increased fixed payment obligations and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or product candidates or grant licenses on terms unfavorable to us. We may also be required to pay damages or have liabilities associated with litigation or other legal proceedings involving our company.
In addition to the foregoing, 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 our ability to access capital, which
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could in the future negatively affect our liquidity. In addition, a recession or market correction due to these factors could materially affect our business and the value of our common stock.
ATM Agreement
In August 2021, we entered into a Controlled Equity OfferingSM Sales Agreement, or the ATM Agreement, with Cantor Fitzgerald & Co. and RBC Capital Markets, LLC, or the Sales Agents, pursuant to which we could offer and sell, from time to time at our sole discretion through the Sales Agents, shares of our common stock having an aggregate offering price of up to $75.0 million. Any shares of our common stock sold were issued pursuant to our 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 are subject to General Instruction I.B.6 of Form S-3, which limits 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. There was no common stock issued under the ATM Agreement during the three months ended March 31, 2024. 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, we entered into an At The Market Offering Agreement (the “Sales Agreement”), with H.C. Wainwright & Co. LLC, relating to the sale of shares of our 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 our common stock sold will be issued pursuant to our shelf registration statement on Form S-3 (File No. 333-283512), which the SEC declared effective on December 6, 2024. However, our use of the shelf registration statement on Form S-3 will be limited for so long as we are subject to General Instruction I.B.6 of Form S-3, which limits the amounts that we may sell under the registration statement and in accordance with the ATM agreement. 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 we have provided H.C. Wainwright & Co. LLC with indemnification and contribution rights.
Between July 17 and 21, 2025, the Company sold 1,624,075 shares of common stock pursuant to our ATM Agreement with H.C. Wainwright & Co., LLC for net proceeds of $4.5 million, after deducting agent commissions, at an average price of $2.87 per share.
On August 26, 2025, the Company sold 3,734,217 shares of common stock pursuant to the ATM Agreement with H.C. Wainwright & Co., LLC for net proceeds of $5.4 million, after deducting agent commissions, at an average price of $1.48 per share.
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 transaction closed on December 23, 2024. 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. Total gross proceeds from the sale of securities in the Private Placement, before deducting commissions to the placement agent and estimated offering expenses, was approximately $16.1 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 were not exercisable until the Company obtained shareholder approval, which approval was received on March 21, 2025.
Going Concern
We have no sources of revenue, other than grant income, to provide incoming cash flows to sustain our future operations. As outlined above, our ability to pursue our long-term planned business activities is dependent upon our successful efforts to raise additional capital.
These factors raise substantial doubt regarding our ability to continue as a going concern. Our condensed consolidated financial statements have been prepared on a going concern basis, which implies that we will continue to realize our assets and discharge our liabilities in the normal course of business. Our financial statements do not include any adjustments to the recoverability and
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classification of recorded asset amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.
Critical Accounting Estimates
The condensed consolidated financial statements are prepared in conformity with U.S. GAAP, which require the use of estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements, and the reported amounts of expenses in the periods presented.
The Company’s critical accounting policies include grant income. The Company does not have any critical accounting estimates.
With respect to grant income, the Company recognizes revenue when qualifying costs are incurred for the amount the Company is entitled to under the provisions of the contract.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
Item 4. Controls and Procedures
(a)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 the end of the period covered by this report 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 as of the end of the period covered by this report. Based on that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures are effective in recording, processing, summarizing, and reporting, on a timely basis, information required to be disclosed by us in the reports that we file or submit under the Exchange Act. Currently, Dr. Vera serves as both our principal executive officer and principal financial officer.
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.
(b)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 September 30, 2025 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II – OTHER INFORMATION
Item 1. 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 legal proceedings, and we are not aware of any pending or threatened legal proceeding against us that we believe could have a material adverse effect on our business, operating results, or financial condition.
Item 1A. Risk Factors
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. In addition to the other information set forth in this quarterly report on Form 10-Q, you should carefully consider the factors described in Part I, Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission on March 31, 2025.
Inadequate funding for the FDA, the SEC, the NIH and other government agencies, including due to government shut downs, or any other disruptions to these agencies’ staffing and operations, could hinder their ability to hire, retain or deploy personnel, and substantial leadership, personnel, and policy changes or otherwise could prevent new products from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes. Average review times at the agency have fluctuated in recent years as a result of these factors. Disruptions at the FDA and other agencies, including substantial leadership departures, personnel cuts and policy changes, may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. Changes and cuts in FDA staffing have been reported by some in the pharmaceutical industry as creating instances of delays in the FDA’s responsiveness or in its ability to review IND submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion or at all. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.
For example, over the last several years the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities. Federal agencies in the U.S. were operating under a continuing resolution that expired on September 30, 2025 and as a result, the federal government is currently shutdown. If the government shutdown is prolonged, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Additionally, disruptions at the NIH or changes to the NIH’s budget may negatively impact our operations and ongoing clinical trials. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
There is substantial uncertainty as to whether and how the new administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates and any products for which we obtain approval. This uncertainty could present new challenges and/or opportunities as we navigate development and approval of our product candidates. Additionally, the new administration could issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or create a more challenging or costly environment to pursue the development of new therapeutic candidates.
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
We did not record any issuances of unregistered securities during the three months ended September 30, 2025.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosure
Not applicable.
Item 5. Other Information
(a) | On August 8, 2025, the Board of Directors of the Company increased Juan Vera’s annual base salary from $400,000 to $440,000. Dr. Vera serves as the Company’s President, Chief Executive Officer and Treasurer. |
(b) | None. |
(c) | Director and Officer Trading Plans and Arrangements. During the quarterly period ended September 30, 2025, no director or officer of the Company |
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Item 6. Exhibits
The following exhibits are included with this Quarterly Report on Form 10-Q:
| Incorporated by Reference | |||||||||||
Exhibit |
| Exhibit description |
| Form |
| File no. |
| Exhibit |
| Filing |
| Filed |
3.1 | 8-K | 001-37939 | 3.4 | 10/17/18 | ||||||||
3.1.1 | 8-K | 001-37939 | 3.1 | 5/27/2022 | ||||||||
3.1.2 | Certificate of Amendment to Amended and Restated Certificate of Incorporation | 8-K | 001-37939 | 3.1 | 1/26/2023 | |||||||
3.2 | 8-K | 001-37939 | 3.6 | 10/17/18 | ||||||||
31.1 | X | |||||||||||
31.2 | X | |||||||||||
32.1* | X | |||||||||||
32.2* | X | |||||||||||
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Exhibit 101
101.INS - XBRL Instance Document
101.SCH - XBRL Taxonomy Extension Schema Document
101.CAL - XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF - XBRL Taxonomy Extension Definition Linkbase Document
101.LAB - XBRL Taxonomy Extension Label Linkbase Document
101.PRE - XBRL Taxonomy Extension Presentation Linkbase Document
104 - Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101 filed herewith).
* | Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing. |
** | 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. |
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SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: November 13, 2025
MARKER THERAPEUTICS, INC.
/s/ Juan Vera | ||
Juan Vera | ||
President, Chief Executive Officer and Treasurer (Principal Executive Officer and Principal Financial and Accounting Officer) |
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