Marker Therapeutics(MRKR) - 2024 Q4 - Annual Results

Report Overview Executive Summary Marker Therapeutics reported significant progress in 2024 for its lead program, MT-601, demonstrating a 78% objective response rate in a Phase 1 lymphoma study. The company strengthened its financial position through over $13 million in non-dilutive funding and a strategic private placement, ensuring a cash runway into Q1 2026. Key operational achievements include receiving the nonproprietary name "neldaleucel" for MT-601 and preparing for clinical program launches for pancreatic cancer and AML in 2025 - The lead program, MT-601, showed a 78% objective response rate and a favorable safety profile in a Phase 1 study for lymphoma patients who relapsed after anti-CD19 CAR-T cell therapy[1][2] - Secured over $13 million in non-dilutive funding from CPRIT and NIH to support pancreatic and lymphoma clinical programs[1] - Strengthened financial position through a strategic private placement, with a focus on cash preservation and disciplined execution to advance clinical programs in 2025[2] - The nonproprietary name "neldaleucel" was approved for MT-601 by the USAN council and INN expert committee[1] Program Updates and Corporate Highlights MT-601 (Lymphoma) The lead MAR-T cell therapy, MT-601 (neldaleucel), is being evaluated in the Phase 1 APOLLO study for relapsed lymphoma. Initial results from the first dose cohort of 9 patients are promising, showing a 78% objective response rate, including a 44.4% complete response rate. The therapy was well-tolerated with no dose-limiting toxicities or significant side effects like ICANS. Enrollment is ongoing, with further data expected in the second half of 2025 Phase 1 APOLLO Study Efficacy (First Dose Cohort) | Metric | Result | Patients (n=9) | | :--- | :--- | :--- | | Objective Response Rate (ORR) | 78% | 7 out of 9 | | Complete Response (CR) | 44.4% | 4 out of 9 | - MT-601 was well-tolerated, with no observed immune-effector cell associated neurotoxicity syndrome (ICANS) and only one case of Grade 1 cytokine release syndrome (CRS). No dose-limiting toxicities have been reported[3] - The company is continuing to enroll participants in the APOLLO trial and anticipates reporting additional data in the second half of 2025[5] MT-601 (Pancreatic) The development of MT-601 for metastatic pancreatic cancer is supported by significant non-dilutive funding. The company received $2 million from the NIH SBIR and $9.5 million from CPRIT. The clinical program for this indication is expected to launch in the second half of 2025 - Received $2 million from NIH SBIR and $9.5 million from CPRIT to support the development of MT-601 in metastatic pancreatic cancer[5] - The clinical program launch for MT-601 in pancreatic cancer is anticipated in the second half of 2025[5] MT-401-OTS (AML/MDS) The company is advancing its "Off-the-Shelf" product, MT-401-OTS, for patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). This therapy is manufactured from healthy donors, and a cellular inventory has been established. The clinical program is expected to begin in the second half of 2025, supported by previously secured non-dilutive funding - MT-401-OTS is an "Off-the-Shelf" product manufactured from healthy donors, with an established cellular inventory[5] - Clinical program initiation for MT-401-OTS in AML/MDS is anticipated during the second half of 2025[5] 2024 Corporate Highlights In 2024, Marker Therapeutics strategically prioritized its clinical pipeline to focus on MT-601 in lymphoma. The company secured a $16.1 million private placement in December from new and existing investors to fund the advancement of the APOLLO study. Additionally, MT-601 was assigned the nonproprietary name "neldaleucel" - Announced a strategic focus on the MT-601 program in lymphoma in January 2024[5] - The nonproprietary (generic) name "neldaleucel" was approved for MT-601[5] - Completed a $16.1 million private placement on December 23, 2024, to support the clinical advancement of the Phase 1 APOLLO study[5] Fiscal Year 2024 Financials Financial Performance Summary For the fiscal year ended December 31, 2024, Marker Therapeutics reported a net loss of $10.7 million. The company ended the year with $19.2 million in cash and cash equivalents, which is expected to fund operations into the first quarter of 2026. Research and development expenses increased to $13.5 million, while general and administrative expenses were significantly reduced to $4.2 million - As of December 31, 2024, the company had cash and cash equivalents of $19.2 million, providing a cash runway into the first quarter of 2026[6] Key Financial Metrics (Year-End) | Metric | 2024 ($ million) | 2023 ($ million) | Change ($ million) | | :--- | :--- | :--- | :--- | | R&D Expenses | $13.5 | $10.4 | +$3.1 | | G&A Expenses | $4.2 | $7.5 | -$3.3 | | Net Loss | $10.7 | $8.2 | +$2.5 | Consolidated Balance Sheets As of December 31, 2024, Marker Therapeutics reported total assets of $22.0 million, an increase from $17.1 million in the prior year. This was primarily driven by a rise in cash and cash equivalents to $19.2 million. Total liabilities remained relatively stable at $3.5 million, while total stockholders' equity increased to $18.6 million from $14.1 million Consolidated Balance Sheet Highlights (Audited) | Account | Dec 31, 2024 ($) | Dec 31, 2023 ($) | | :--- | :--- | :--- | | Cash and cash equivalents | $19,192,440 | $15,111,450 | | Total Assets | $22,022,860 | $17,127,391 | | Total Liabilities | $3,464,454 | $3,074,848 | | Total Stockholders' Equity | $18,558,406 | $14,052,543 | Consolidated Statements of Operations For the year ended December 31, 2024, the company's revenues, entirely from grant income, nearly doubled to $6.6 million from $3.3 million in 2023. Total operating expenses remained flat at approximately $17.7 million, as a $3.1 million increase in R&D was offset by a $3.3 million decrease in G&A. The loss from operations improved to $11.1 million from $14.6 million in the prior year. The reported net loss was $10.7 million, or ($1.19) per share, compared to a net loss of $8.2 million, or ($0.94) per share, in 2023, with the prior year benefiting from income from discontinued operations Consolidated Statement of Operations Highlights (Audited) | Account | For the Year Ended Dec 31, 2024 ($) | For the Year Ended Dec 31, 2023 ($) | | :--- | :--- | :--- | | Grant Income | $6,591,080 | $3,311,133 | | Total Operating Expenses | $17,709,452 | $17,892,511 | | Loss from Operations | ($11,118,372) | ($14,581,378) | | Net Loss | ($10,731,315) | ($8,236,814) | | Net Loss Per Share | ($1.19) | ($0.94) | Consolidated Statements of Cash Flows For the year ended December 31, 2024, net cash used in operating activities was $10.9 million. The company generated $15.0 million in net cash from financing activities, primarily from the issuance of common stock. This resulted in a net increase in cash of $4.1 million, bringing the year-end cash and cash equivalents balance to $19.2 million Consolidated Statement of Cash Flows Highlights (Audited) | Activity | For the Year Ended Dec 31, 2024 ($) | For the Year Ended Dec 31, 2023 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | ($10,910,324) | ($16,439,961) | | Net cash provided by investing activities | $0 | $18,664,122 | | Net cash provided by financing activities | $14,991,314 | $1,105,117 | | Net increase in cash | $4,080,990 | $3,329,278 | | Cash at end of period | $19,192,440 | $15,111,450 | Company and Technology Overview About MAR-T cells The company's core technology is the multi-antigen recognizing (MAR) T cell platform. It is a non-genetically modified cell therapy approach that expands a patient's own T cells to recognize a wide range of tumor antigens (up to six). This multi-target approach is designed to reduce the likelihood of tumor escape. Marker believes this method will be less expensive to manufacture and have an improved safety profile compared to current engineered T cell therapies - MAR-T is a novel, non-genetically modified cell therapy that expands T cells to recognize a broad range of tumor antigens[8] - The platform allows recognition of hundreds of epitopes within up to six tumor-specific antigens, reducing the potential for tumor escape[8] - Marker believes its product candidates will be easier and less expensive to manufacture with an improved safety profile compared to current engineered T cell therapies[8] About Marker Therapeutics, Inc. Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company based in Houston, TX, focused on developing next-generation T cell immunotherapies for hematological malignancies and solid tumors. Founded at Baylor College of Medicine, the company's therapies have been tested in over 200 patients, showing good tolerance and durable clinical responses. The company's strategy prioritizes financial discipline and operational excellence, leveraging non-dilutive funding from state and federal agencies - A clinical-stage immuno-oncology company specializing in T cell-based immunotherapies for hematological malignancies and solid tumors[9] - The company's strategy prioritizes the preservation of financial resources and focuses on operational excellence[9] - The T cell platform is strengthened by non-dilutive funding from U.S. state and federal agencies supporting cancer research[9]