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
“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
“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
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 67thAmerican Society of Hematology (ASH) Annual Meeting inDecember 2025 . Key findings from the update included:- 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).
- 78% objective response rate (7/9) observed in patients with Hodgkin lymphoma.
- 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 theCancer Prevention and Research Institute of Texas (CPRIT). - Nature Medicine publication (
January 2026 ): Researchers atBaylor 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), theFood and Drug Administration (FDA) and theCancer 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
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Marker reported a net loss of
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.
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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-
Consolidated Balance Sheets (Audited) |
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| 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, |
— | — | |||||
| Common stock, |
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 | |||
Consolidated Statements of Operations (Audited) |
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| For the Years Ended | |||||||
| 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 | |||||
Consolidated Statements of Cash Flows (Audited) |
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| For the Years Ended | |||||||
| 2025 |
2024 |
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| 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
+1 (713) 400-6400
investor.relations@markertherapeutics.com
Source: Marker Therapeutics