MRKR

Business Context and Reporting Period

Company: Marker Therapeutics, Inc. (MRKR)
Filing Type: Form 10-K (Annual Report)
Period Ended: December 31, 2025
Business Overview: Marker is a clinical-stage immuno-oncology company developing Multi Antigen Recognizing (MAR)-T cell therapies. Unlike genetically engineered CAR-T therapies, Marker's approach selectively expands natural tumor-specific T cells to target multiple antigens simultaneously, aiming to reduce tumor escape and toxicity. The company has no approved products and generates no product revenue.

Key Financial Metrics

Note: The company has no debt. All revenue is derived from government and foundation grants.

Material Changes vs. Prior Period

• Revenue Decline: Grant income decreased by 46% ($3.04 million) year-over-year, primarily due to a significant reduction in funding recognized from the CPRIT AML Grant.
• Net Loss Increase: Net loss increased by approximately 13% to $12.16 million, driven largely by the reduction in grant income offsetting a modest 7% decrease in operating expenses.
• Vendor Termination: The company recorded a one-time loss of $453,135 related to the early termination of a Master Services Agreement with Cell Ready, LLC, a related-party contract manufacturer.
• Capital Raises: In 2025, the company raised approximately $9.9 million in net proceeds through an At-The-Market (ATM) offering with H.C. Wainwright & Co. LLC. In late 2024, a private placement raised approximately $14.9 million.

Guidance, Outlook, and Risks

Clinical Progress

• MT-601 (Lymphoma): The Phase 1 APOLLO study reported favorable safety and efficacy data as of June 2025. In 12 evaluable Non-Hodgkin Lymphoma (NHL) patients, 66% achieved objective responses, with 50% achieving complete response. The study has advanced to the dose expansion phase.
• MT-601 (Pancreatic Cancer): The PANACEA Phase 1 trial is ongoing. The company received a $9.5 million grant from CPRIT in December 2024 to support this program.
• MT-401-OTS (AML/MDS): The first patient was treated in the Off-the-Shelf (OTS) program in October 2025, with encouraging preliminary safety data.

Liquidity and Going Concern

Management has raised substantial doubt regarding the company's ability to continue as a going concern. Based on current cash balances of $17.04 million and historical burn rates, the company anticipates funding operations through the fourth quarter of 2026, assuming no additional grant funds are received. The company plans to raise additional capital through equity issuances and grant applications.

Key Risks

• Capital Requirements: Continued reliance on equity financing and grants; potential dilution of shareholders.
• Manufacturing Dependence: Reliance on third-party vendors (Baylor College of Medicine and Cellipont Bioservices) for clinical and commercial manufacturing.
• Regulatory Uncertainty: No MAR-T cell therapy has been approved by the FDA; clinical trial results may not predict future outcomes.

Investor Verification Checklist

• Cash Runway: Verify the accuracy of the "fourth quarter of 2026" liquidity estimate given the high burn rate and potential for increased clinical costs.
• Grant Sustainability: Assess the likelihood of receiving future tranches from CPRIT, NIH, and FDA grants, which constitute 100% of revenue.
• Manufacturing Transition: Monitor the technology transfer progress with the new CDMO, Cellipont Bioservices, following the termination of the Cell Ready agreement.
• Clinical Data Durability: Review long-term follow-up data from the APOLLO study to confirm the durability of the reported complete responses in lymphoma patients.
• Dilution Impact: Evaluate the impact of outstanding warrants (approx. 7.7 million shares) and options (approx. 1.8 million shares) on future equity value.