On November 14, 2025 Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company developing next-generation T cell-based therapies, reported corporate updates and financial results for the third quarter ended September 30, 2025.

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"Marker entered the second half of 2025 with strong clinical momentum as we continue to advance our lead program, MT-601, in patients with relapsed or refractory B-cell lymphoma," said Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. "The most recent update from our Phase 1 APOLLO study showed a 66% objective response rate including 50% complete responses, in heavily pre-treated NHL patients. These data, together with a favorable safety profile, reinforce the potential of MT-601 to meet the critical needs of patients who have exhausted multiple lines of therapy, including CAR-T cell therapies and bispecific antibodies. We’re encouraged by the durability of responses and plan to share an additional update in the first half of 2026."

Dr. Vera continued, "We also achieved a number of key milestones in this quarter, including treating the first patient in our Off-the-Shelf (OTS) program and entering a strategic manufacturing collaboration with Cellipont to scale up production of MT-601. In parallel, we have strengthened our balance sheet by raising approximately $10 million through our ATM facility, extending our cash runway well into 2026. Looking ahead, we are focused on enrolling patients in the MT-601 dose expansion cohort to build on our promising observations from our APOLLO study. Having executed on the priorities we set at the beginning of the year we are entering the final stretch of 2025 with strong operational footing and a clear clinical focus."

PROGRAM UPDATES & OPERATIONAL HIGHLIGHTS

MT-601 (Lymphoma)

· Positive clinical data from the Phase 1 APOLLO study (clinicaltrials.gov identifier: NCT05798897) showed a 66% (8 out of 12) objective response rate and 50% (6 out of 12) complete response rate in relapsed NHL patients, including those previously treated with CAR-T cell therapies and bispecific antibodies (Press Release, August 26, 2025).

· Responses were durable with five NHL patients maintaining response for ≥6 months, including three with ≥12 months (range 3-24 months).

· Favorable safety profile with no dose-limiting toxicities (DLTs) or immune effector cell–associated neurotoxicity (ICANS) observed at any dose level in the dose escalation cohort.

· Dose expansion cohort underway, evaluating MT-601 at highest dose level (400×106 cells) in patients with Diffuse Large B Cell Lymphoma (DLBCL) who have relapsed after or are ineligible for CAR-T cell therapy.

· Additional clinical data are expected in the first half of 2026.

MT-601 (Pancreatic Cancer)

· Marker was previously awarded $2.0 million from the NIH and $9.5 million from the Cancer Prevention and Research Institute of Texas (CPRIT) to support the development of MT-601 in metastatic pancreatic cancer.

· Clinical program launch is anticipated in the first half of 2026.

Off-the-Shelf Program (Acute Myeloid Leukemia or Myelodysplastic Syndrome)

· Marker announced first patient treated in Phase 1 RAPID study (clinicaltrials.gov Identifier: NCT06552416) evaluating MT-401 as an Off-the-Shelf (OTS) product (Press Release, October 6, 2025).

· Treatment with MT-401-OTS was well tolerated, consistent with the favorable safety profile previously reported for MAR-T cells.

· The OTS program is investigating MAR-T cells in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) with the potential for future expansion to other indications.

· The Company previously secured non-dilutive funding from NIH, FDA and CPRIT to support the OTS program.

Corporate Updates

· Marker entered a current good manufacturing practice (cGMP) manufacturing agreement with Cellipont Bioservices to scale up the production of MT-601 for the APOLLO study. This partnership supports clinical supply and lays the ground for a potential pivotal trial and commercial readiness (Press Release, June 17, 2025).

· Data from the Phase 1 APOLLO study will be presented in two posters at the 67th ASH (Free ASH Whitepaper) Annual Meeting and Exposition, held from December 6-9, 2025, in Orlando, Florida (Press Release, November 3, 2025).

· Appointed Kathryn Penkus Corzo, R.Ph., MBA to the Company’s Board of Directors, effective November 1, 2025 (Press Release, November 5, 2025).

· Marker raised approximately $10 million through its ATM Agreement, extending the Company’s runway well into 2026.

THIRD QUARTER 2025 FINANCIAL HIGHLIGHTS

Cash Position and Guidance: At September 30, 2025, Marker had cash and cash equivalents of $17.6 million and restricted cash of $1.4 million. The Company believes that its existing cash, cash equivalents and restricted cash will fund its operating expenses through the third 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 $2.3 million for the quarter ended September 30, 2025, compared to $3.5 million for the quarter ended September 30, 2024.

G&A Expenses: General and administrative expenses were $1 million for the quarter ended September 30, 2025, compared to $0.9 million for the quarter ended September 30, 2024.

Net Loss: Marker reported a net loss from continuing operations of $2.0 million for the quarter ended September 30, 2025, compared to $2.3 million for the quarter ended September 30, 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.

(Press release, Marker Therapeutics, NOV 14, 2025, View Source [SID1234659974])