Marker Therapeutics Q1 2024 Financial Results and Business Updates

HOUSTON, May 15, 2024 – Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company, announced updates and financial results for the first quarter ending March 31, 2024. The company focuses on developing next-generation T cell-based immunotherapies for hematological malignancies and solid tumors.

Dr. Juan Vera, President and CEO of Marker Therapeutics, expressed satisfaction with the substantial progress in their clinical programs in the first quarter of 2024. Highlighting the achievements, he mentioned the continued observation of objective responses in their Phase 1 APOLLO study that investigates MT-601 in lymphoma patients who have relapsed or are ineligible for CAR T therapy. A noteworthy development is the complete response in a patient who relapsed within 90 days of CAR T therapy, maintaining the response nine months post-treatment with MT-601. This underscores the potential superiority of MT-601 in terms of durability.

In April, the Principal Investigator at City of Hope National Medical Center shared findings from the APOLLO trial at a medical conference. The data revealed that three out of three subjects treated at City of Hope demonstrated objective responses, reinforcing the potential benefits of MT-601 for lymphoma patients. The company plans a comprehensive clinical update on the APOLLO study in the latter half of the year.

Another significant milestone was the approval received from the United States Adopted Name (USAN) Council and the International Nonproprietary Names (INN) expert committee for “neldaleucel” as the nonproprietary name for MT-601. This development marks a crucial step forward in achieving the company's objectives relating to MT-601 for lymphoma treatment.

The program updates for MT-601 (Lymphoma) indicate that the Phase 1 multicenter APOLLO trial (clinicaltrials.gov identifier: NCT05798897) was selected as the lead program due to promising preliminary clinical results. Three patients treated at City of Hope National Medical Center showed impressive responses. The first participant with diffuse large B cell lymphoma (DLBCL) achieved a complete response eight weeks after the second infusion of MT-601 and maintained this response nine months post-treatment. Another participant with transformed follicular Non-Hodgkin’s Lymphoma (NHL) also showed a complete response three months post-treatment. The third participant with DLBCL and cutaneous involvement, who was ineligible for CAR T cell therapy, achieved a partial response with significant lesion reduction.

The treatment has been well tolerated with no significant adverse events, including cytokine release syndrome or neurotoxicity. Participants continue to be observed for the durability of response. The company is enrolling more patients in the Phase 1 APOLLO trial and anticipates reporting further data in the second half of 2024.

Additionally, MT-601 received the non-proprietary name “neldaleucel.” In the pancreatic cancer domain, an Investigational New Drug (IND) application has been cleared by the U.S. FDA for a Phase 1 trial of MT-601 in combination with front-line chemotherapy, subject to additional financial support.

For MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic Syndrome), the company has focused resources on an "Off-the-Shelf" product. The U.S. FDA granted an IND to investigate MT-401-OTS in these patients, with clinical program initiation anticipated for the second half of 2024.

Financial highlights for the first quarter of 2024 include a cash position of $11.3 million, projected to fund operations into the fourth quarter of 2025. Research and development expenses were $2.6 million, and general and administrative expenses were $1.2 million. The net loss reported was $2.4 million for the quarter, down from $4.9 million in the same period the previous year.

Marker Therapeutics aims to introduce innovative T cell therapies to improve patient outcomes and focuses on operational excellence and financial resource preservation. Their multi-tumor associated antigen (multiTAA)-specific T cell platform offers a unique, non-genetically modified cell therapy approach. This method is anticipated to be easier and less costly to manufacture, with reduced toxicities compared to current gene-modified therapies. The company leverages non-dilutive funding from U.S. agencies supporting cancer research.