MRKR 8-K
Marker Therapeutics, Inc. (MRKR)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 2.02 | Results of Operations and Financial Condition. |
On March 18, 2026, Marker Therapeutics, Inc. (the “Company”) reported financial results for the year ended December 31, 2025 and other recent corporate updates. A copy of the press release is furnished as Exhibit 99.1 to this report and incorporated by reference.
The information in this Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information shall not be deemed incorporated by reference into any other filing with the Securities and Exchange Commission made by the Company, whether made before or after today’s date, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific references in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. | Description |
| 99.1 | Press Release dated March 18, 2026 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Marker Therapeutics, Inc. | ||
| Dated: March 18, 2026 | By: | /s/ Juan Vera |
| Juan Vera | ||
| President and Chief Executive Officer | ||
Exhibit 99.1
Marker Therapeutics Reports Year-End 2025 Corporate and Financial Results
Phase 1 APOLLO data update demonstrated encouraging clinical activity with a 66% objective response rate in relapsed non-Hodgkin lymphoma, including 50% complete responses
Research published in Nature Medicine highlighted promising results of multi-antigen targeted T cells in pancreatic cancer
Strengthened manufacturing capabilities through collaboration with Cellipont Bioservices and expanded Board of Directors with appointment of Kathryn Penkus Corzo
HOUSTON, TX – March 18, 2026 (GLOBE NEWSWIRE) — Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company developing next-generation T cell-based immunotherapies for hematological malignancies and solid tumors, today announced corporate updates and financial results for the year ended December 31, 2025.
“In 2025, we continued to advance MT-601, our lead Multi-Antigen Recognizing (MAR)-T cell therapy, and generated highly encouraging clinical data from our ongoing Phase 1 APOLLO study,” said Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. “Updated results reported last August demonstrated a 66% objective response rate in relapsed non-Hodgkin lymphoma, including durable complete responses, with a favorable safety profile across evaluated doses. During the year we also reported immunomonitoring data indicating that lymphodepletion enhances the expansion and persistence of MT-601, and we advanced the APOLLO study into dose expansion in patients with relapsed Diffuse Large B Cell Lymphoma (DLBCL). We anticipate providing a data update from the APOLLO study in the second quarter of 2026.”
Dr. Vera continued, “Beyond lymphoma, we made important progress expanding our MAR-T platform across hematologic and solid tumors. Recent research from Baylor College of Medicine published in Nature Medicine in early 2026 showed promising results in pancreatic cancer using MAR-T cells and received national coverage on Good Morning America.”
“Looking ahead, we expect continued clinical execution across our programs, including additional APOLLO data updates and initiation of our company-sponsored pancreatic cancer clinical program, which we believe positions the next 12 to 18 months as an important value-creating period for Marker,” concluded Dr. Vera.
2025 PROGRAM UPDATES & OPERATIONAL HIGHLIGHTS
MT-601 (Lymphoma)
| - | MT-601, Marker’s lead MAR-T cell therapy, is being evaluated in the nationwide multicenter APOLLO study (clinicaltrials.gov identifier: NCT05798897) in patients with lymphoma who have relapsed after anti-CD19 CAR-T cell therapy or for whom CAR-T therapy is not an option. |
| - | The Company provided an update on the Phase 1 study in August 2025 (Press Release, Aug 26, 2025) highlighting encouraging overall response rates. These data were also presented at the 67th American Society of Hematology (ASH) Annual Meeting in December 2025. Key findings from the update included: |
| o | 66% objective response rate (8/12) in patients with relapsed non-Hodgkin lymphoma, including 50% complete responses. Durable responses were observed (range 3-24 months). |
| o | 78% objective response rate (7/9) observed in patients with Hodgkin lymphoma. |
| o | Favorable safety profile across all dose levels (100×10⁶–400×10⁶ cells), with no dose-limiting toxicities (DLTs) and no ICANS reported. |
| - | The dose expansion phase of the study is enrolling patients with anti-CD19 CAR-relapsed Diffuse Large B Cell Lymphoma (DLBCL) at the maximum dose level (400×10⁶ cells). |
| - | Additional patient data and FDA feedback on study design are expected in the second quarter of 2026. |
MT-601 (Pancreatic Cancer)
| - | Marker continues to advance MT-601 in pancreatic cancer, supported by non-dilutive funding from the National Institutes of Health (NIH), Small Business Innovation Research (SBIR) program and the Cancer Prevention and Research Institute of Texas (CPRIT). |
| - | Nature Medicine publication (January 2026): Researchers at Baylor College of Medicine reported encouraging results evaluating multi-antigen targeted T cells in pancreatic cancer, demonstrating a favorable safety profile and up to 84.6% disease control rate when combined with frontline chemotherapy (Press Release, Jan 5, 2026). |
| - | Marker expects to initiate its company-sponsored pancreatic cancer program in the second quarter of 2026, incorporating learnings from prior studies. |
MT-401 Off-the-Shelf Program (AML/MDS)
| - | Marker is evaluating MT-401, a MAR-T cell therapy targeting four antigens, as an Off-the-Shelf (OTS) product in the Phase 1 RAPID study in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). |
| - | The study is supported by non-dilutive grant funds from National Cancer Institute (NCI), the Food and Drug Administration (FDA) and the Cancer Prevention and Research Institute of Texas (CPRIT). |
ADDITIONAL 2025 CORPORATE HIGHLIGHTS
| - | Manufacturing collaboration with Cellipont Bioservices to advance cGMP production of MT-601. Technical transfer expected to be completed in Q2 2026. |
| - | Kathryn Penkus Corzo, R.Ph., MBA joined the Board of Directors (November 1, 2025). |
FISCAL YEAR 2025 FINANCIAL HIGHLIGHTS
Cash Position and Guidance: At December 31, 2025, Marker had cash, cash equivalents and restricted cash of $17 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses through the fourth quarter of 2026, assuming no additional grant funds are received, either from new grants or from existing awarded grants.
R&D Expenses: Research and development expenses were $11.8 million for the year ended December 31, 2025, compared to $13.5 million for the year ended December 31, 2024.
G&A Expenses: General and administrative expenses were $4.2 million for the year ended December 31, 2025, compared to $4.2 million for the year ended December 31, 2024.
Net Loss: Marker reported a net loss of $12.2 million for the year ended December 31, 2025, compared to a net loss of $10.7 million for the year ended December 31, 2024.
About MAR-T cells
The multi-antigen recognizing (MAR) T cell platform (formerly known as multiTAA-specific T cells) is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient's/donor’s blood capable of recognizing a broad range of tumor antigens. Unlike other T cell therapies, MAR-T cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since MAR-T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with an improved safety profile compared to current engineered T cell approaches and may provide patients with meaningful clinical benefits.
About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a Houston, TX-based clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors. The Company was founded at Baylor College of Medicine, and clinical trials that enrolled more than 200 patients across various hematological and solid tumor indications showed that the Company’s autologous and allogeneic MAR-T cell products were well tolerated and demonstrated durable clinical responses. Marker’s goal is to introduce novel T cell therapies to the market and improve patient outcomes. To achieve these objectives, the Company prioritizes the preservation of financial resources and focuses on operational excellence. Marker’s unique T cell platform is strengthened by non-dilutive funding from U.S. state and federal agencies supporting cancer research. The APOLLO study is supported by the National Cancer Institute of the National Institutes of Health under Award Number R44CA291521. The Company’s pancreatic cancer program is supported by the National Cancer Institute of the National Institutes of Health (Award Number R44CA295168), and the Cancer Prevention and Research Institute of Texas (CPRIT, Award Number DP250150). Marker’s OTS program is supported by the National Cancer Institute of the National Institutes of Health (Award Number 1R44CA285177), the Food and Drug Administration Department of Health and Human Services (R01FD007272), and the Cancer Prevention and Research Institute of Texas (CPRIT, Award Number DP210042).
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Forward-Looking Statements
This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and the timing, conduct, interim results announcements and outcomes of our clinical trials of our product candidates, including MT-601 for the treatment of patients with lymphoma or pancreatic cancer, and MT-401-OTS for the treatment of patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at WWW.SEC.GOV. The Company assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release except as may be required by law.
Marker Therapeutics, Inc.
Consolidated Balance Sheets
(Audited)
| December 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 16,068,048 | $ | 19,192,440 | ||||
| Restricted cash | 974,799 | — | ||||||
| Prepaid expenses and deposits | 658,750 | 483,717 | ||||||
| Other receivables | 1,369,400 | 2,346,703 | ||||||
| Total current assets | 19,070,997 | 22,022,860 | ||||||
| Total assets | $ | 19,070,997 | $ | 22,022,860 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 1,299,384 | $ | 1,753,954 | ||||
| Related party payable | — | 1,710,500 | ||||||
| Deferred revenue | 974,799 | — | ||||||
| Total current liabilities | 2,274,183 | 3,464,454 | ||||||
| Total liabilities | 2,274,183 | 3,464,454 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $0.001 par value, 5 million shares authorized, 0 shares issued and outstanding at December 31, 2025 and 2024, respectively | — | — | ||||||
| Common stock, $0.001 par value, 30 million shares authorized, 16.7 million and 10.7 million shares issued and outstanding as of December 31, 2025 and 2024, respectively (see Note 7) | 16,672 | 10,708 | ||||||
| Additional paid-in capital | 475,960,940 | 465,564,876 | ||||||
| Accumulated deficit | (459,180,798 | ) | (447,017,178 | ) | ||||
| Total stockholders’ equity | 16,796,814 | 18,558,406 | ||||||
| Total liabilities and stockholders’ equity | $ | 19,070,997 | $ | 22,022,860 | ||||
Marker Therapeutics, Inc.
Consolidated Statements of Operations
(Audited)
| For the Years Ended | ||||||||
| December 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenues: | ||||||||
| Grant income | $ | 3,546,669 | $ | 6,591,080 | ||||
| Total revenues | 3,546,669 | 6,591,080 | ||||||
| Operating expenses: | ||||||||
| Research and development | 11,799,154 | 13,467,845 | ||||||
| General and administrative | 4,184,806 | 4,241,607 | ||||||
| Loss on early termination of vendor agreement | 453,135 | — | ||||||
| Total operating expenses | 16,437,095 | 17,709,452 | ||||||
| Loss from operations | (12,890,426 | ) | (11,118,372 | ) | ||||
| Other income: | ||||||||
| Interest income | 594,206 | 437,010 | ||||||
| Other income | 117,444 | — | ||||||
| Loss from operations before income taxes | (12,178,776 | ) | (10,681,362 | ) | ||||
| Income tax (benefit) expense | (15,156 | ) | 49,953 | |||||
| Net loss | (12,163,620 | ) | (10,731,315 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.79 | ) | $ | (1.19 | ) | ||
| Weighted average number of common shares outstanding: | ||||||||
| Basic | 15,310,308 | 8,980,207 | ||||||
| Diluted | 15,310,308 | 8,980,207 | ||||||
Marker Therapeutics, Inc.
Consolidated Statements of Cash Flows
(Audited)
| For the Years Ended | ||||||||
| December 31, | ||||||||
| 2025 | 2024 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (12,163,620 | ) | $ | (10,731,315 | ) | ||
| Reconciliation of net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 537,540 | 245,864 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and deposits | (175,033 | ) | 504,409 | |||||
| Other receivables | 977,303 | (1,318,888 | ) | |||||
| Related party payable | (1,710,500 | ) | 380,845 | |||||
| Accounts payable and accrued expenses | (454,570 | ) | 8,761 | |||||
| Deferred revenue | 974,799 | — | ||||||
| Net cash used in operating activities | (12,014,081 | ) | (10,910,324 | ) | ||||
| Cash Flows from Financing Activities: | ||||||||
| Proceeds from issuance of common stock, net | 9,863,883 | 14,929,155 | ||||||
| Proceeds from exercise of warrants and stock options | 605 | 62,159 | ||||||
| Net cash provided by financing activities | 9,864,488 | 14,991,314 | ||||||
| Net (decrease) increase in cash, cash equivalents, and restricted cash | (2,149,593 | ) | 4,080,990 | |||||
| Cash, cash equivalents, and restricted cash at beginning of the year | 19,192,440 | 15,111,450 | ||||||
| Cash, cash equivalents, and restricted cash at end of the year | $ | 17,042,847 | $ | 19,192,440 | ||||
Media and Investor Contact
Marker Therapeutics, Inc.
+1 (713) 400-6400
[email protected]