Marker Therapeutics, Inc.

What they do

Marker Therapeutics develops T cell-based immunotherapies using its Multi Antigen Recognizing (MAR)-T cell technology, licensed from Baylor College of Medicine in March 2018. The approach selectively expands natural tumor-specific T cells from a patient's or donor's blood that recognize multiple tumor-associated antigens without genetic modification. Its lead candidate, MT-601, targets six antigens (Survivin, PRAME, WT1, NY-ESO-1, SSX-2, MAGEA-4) and is in the Phase 1 APOLLO study in lymphoma and in development for pancreatic cancer; MT-401 is an off-the-shelf candidate in the Phase 1 RAPID study in AML/MDS.

Revenue drivers

• Grant and non-dilutive funding — Operations are supported by non-dilutive funding, including NIH SBIR awards and CPRIT for the pancreatic cancer program and NCI and FDA-related grant funds for the MT-401 OTS RAPID study.
• MT-601 (lymphoma) — Lead MAR-T cell product in the Phase 1 APOLLO study in patients who relapsed after or are ineligible for anti-CD19 CAR-T; no product revenue is reported from this program.
• MT-601 (pancreatic cancer) — Company-sponsored pancreatic cancer program expected to initiate in Q2 2026, supported by NIH SBIR and CPRIT non-dilutive funding rather than product sales.
• MT-401 off-the-shelf (AML/MDS) — OTS MAR-T cell candidate targeting four antigens in the Phase 1 RAPID study in AML or MDS, supported by NCI grant funds.

Recent performance

Annual revenue fell to $3.5M in 2025 from $6.6M in 2024, while net loss widened to $12.2M from $10.7M. Diluted EPS improved to -$0.79 in 2025 from -$1.19 in 2024. Recent quarterly revenue was $861,184 in Q2 2025, $1.2M in Q3 2025, $1.1M in Q4 2025 and $751,691 in Q1 2026. Operating cash flow was -$12.0M in 2025 versus -$10.9M in 2024. At June 30, 2026 the company reported $11.3M in cash and equivalents against $2.4M of total liabilities and $12.2M of shareholder equity.

Strategy

Marker is advancing MT-601 in the Phase 1 APOLLO study, which has moved into dose expansion in anti-CD19 CAR-relapsed DLBCL at the 400 x 10^6 cell maximum dose level. The company expects to initiate its company-sponsored pancreatic cancer program in Q2 2026, incorporating learnings from prior studies. It is also evaluating MT-401 as an off-the-shelf product in AML or MDS through the Phase 1 RAPID study. Manufacturing is outsourced, including a February 2024 Master Services Agreement for Product Supply with Cell Ready, a CDMO owned by former director John Wilson, and a collaboration with Cellipont Bioservices. The company states it is assessing combinations of MAR-T cell products with other products.

Risks

• Going concern — The 10-K states the company's history of operating losses and expected indefinite future losses raise substantial doubt about its ability to continue as a going concern.
• Early-stage clinical failure — All product candidates remain in clinical development, and the 10-K cautions that earlier preclinical and clinical trial results may not predict future results.
• FDA regulatory delay — The 10-K notes the FDA approval process is lengthy and time-consuming and that significant delays in clinical development and approval are possible.
• Third-party dependence — The company depends on third-party vendors and CDMOs, including Cell Ready, which is owned by one of its former directors, to maintain its manufacturing and research operations.

Outlook

Management says it anticipates a data update from the Phase 1 APOLLO study in Q2 2026, including additional patient data and FDA feedback on study design. It expects to initiate the company-sponsored pancreatic cancer clinical program in Q2 2026. The CEO described the next 12 to 18 months as an important period for continued clinical execution across the programs.