Marker Therapeutics Announces Q2 2024 Financial Results and Business Updates

Preliminary safety and efficacy with sustained objective responses observed in patients with lymphoma treated with MT-601 in Phase 1 APOLLO study. MT-601 was well tolerated with no observation of cytokine release syndrome (CRS) or immune effector cell associated neurotoxicity syndrome (ICANS). Marker Therapeutics to receive $2 million funding from NIH Small Business Innovation Research (SBIR) program to support clinical investigation of MT-601 in patients with lymphoma.

Marker Therapeutics, Inc., a Houston-based clinical-stage immuno-oncology firm, reported significant corporate updates and financial outcomes for the second quarter ending June 30, 2024. The company focuses on next-generation T cell-based immunotherapies to treat various cancers, including hematological malignancies and solid tumors.

Highlighting the company’s clinical progress, CEO Juan Vera emphasized the continuous momentum in their Phase 1 APOLLO study. This study examines MT-601 in lymphoma patients who have relapsed post anti-CD19 CAR-T cell therapy or cannot undergo CAR-T therapy. Dr. Geoffrey Shouse from City of Hope National Medical Center shared promising data in April at the 11th Global Summit on Hematologic Malignancies, showing that all three participants exhibited objective responses and well-tolerated treatment with no severe adverse events.

Post-second quarter, Marker Therapeutics announced a $2 million SBIR grant from the NIH to support the ongoing APOLLO study, underscoring the study’s scientific merit and its potential to address unmet medical needs in non-Hodgkin’s lymphoma patients who have relapsed after anti-CD19 CAR-T cell therapy.

Program Updates & Expected Milestones

MT-601 (Lymphoma):
The APOLLO study, a multicenter Phase 1 trial, is examining MT-601 in patients with lymphoma who have relapsed following anti-CD19 CAR-T cell therapy or for whom CAR-T therapy is not feasible. Early safety and efficacy results indicated sustained objective responses in three City of Hope National Medical Center participants, with no CRS or ICANS observed. The study continues to enroll participants, with long-term treatment effects and response durability being monitored. Further safety and durability updates are expected in the third quarter. The company received a $2 million SBIR grant to support this study.

MT-601 (Pancreatic):
The FDA has cleared an Investigational New Drug (IND) application for a Phase 1 trial to investigate MT-601 with front-line chemotherapy in metastatic pancreatic cancer patients. Further progress depends on additional financial backing.

MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic Syndrome):
The FDA has granted an IND application to investigate MT-401 as an "Off-the-Shelf" (MT-401-OTS) product for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) patients. Manufactured from healthy donors, Marker has created a cellular inventory for MT-401-OTS and is working on further expansion. Preclinical data show potential clinical benefits. The company has secured non-dilutive funding to support MT-401-OTS clinical investigations, with the program expected to launch in the fourth quarter of 2024.

Financial Highlights for Second Quarter 2024

Cash Position:
As of June 30, 2024, Marker had $7.8 million in cash and cash equivalents. The company projects this will cover operational expenses into the fourth quarter of 2025, considering available grant funds.

Research & Development Expenses:
R&D expenses for the quarter were $2.3 million, down from $2.4 million the previous year.

General & Administrative Expenses:
G&A expenses declined to $1.1 million from $2.5 million in the same quarter the previous year.

Net Loss:
The company reported a net loss of $2.2 million for the quarter, compared to a $4.1 million loss in the same period in 2023.

CEO Juan Vera noted the financial benefits of the restructuring efforts initiated in the second quarter of 2023, particularly the agreement with Cell Ready, which has positively impacted operational expenses. The company’s efficient structure and successful grant funding initiatives allow Marker to maximize its cash resources, focusing on clinical programs.

About multiTAA-specific T cells

The multi-tumor associated antigen (multiTAA)-specific T cell platform is a novel, non-genetically modified cell therapy approach that expands tumor-specific T cells from blood capable of recognizing various tumor antigens. Unlike genetically engineered T cell therapies, multiTAA-specific T cells recognize multiple epitopes within several tumor-specific antigens, potentially reducing tumor escape. This approach is believed to be easier and less costly to manufacture, with improved safety profiles and meaningful clinical benefits.

About Marker Therapeutics, Inc.

Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company developing next-generation T cell-based immunotherapies for hematological malignancies and solid tumors. With clinical trials involving over 200 patients across various cancer indications, the company aims to introduce novel T cell therapies to improve patient outcomes. Marker prioritizes financial resource preservation and operational excellence, bolstered by non-dilutive funding from state and federal agencies supporting cancer research.

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