Marker Therapeutics(MRKR) - 2024 Q1 - Quarterly Results

First Quarter 2024 Business and Clinical Update Marker Therapeutics provides an overview of its Q1 2024 business and clinical advancements, highlighting promising MT-601 lymphoma data and program milestones First Quarter 2024 Highlights Marker Therapeutics reported promising preliminary Phase 1 APOLLO study data for MT-601 in lymphoma, showing sustained objective responses and securing the nonproprietary name "neldaleucel" - Preliminary safety and efficacy with sustained objective responses were observed in lymphoma patients treated with MT-601 in the Phase 1 APOLLO study[1] - A study participant with Non-Hodgkin's Lymphoma, who had relapsed within 90 days of anti-CD19 CAR T cell therapy, remains in complete response nine months after receiving MT-601 treatment[1][2] - MT-601 received the approved nonproprietary name "neldaleucel" from the United States Adopted Name (USAN) council and the International Nonproprietary Names (INN) expert committee[1][2] Program Updates & Expected Milestones The company is prioritizing the MT-601 lymphoma program, while the pancreatic cancer program awaits funding and the AML program shifts to an "Off-the-Shelf" approach MT-601 (Lymphoma) The MT-601 lymphoma program, selected as the lead, shows objective responses in all three initial patients with plans for further enrollment and data reporting - The Phase 1 multicenter APOLLO trial for MT-601 was selected as the lead program for patients with lymphoma who relapsed or are ineligible for anti-CD19 CAR T cell therapies[3] - All three patients treated at City of Hope demonstrated objective responses (two complete, one partial) and the treatment was well-tolerated with no significant treatment-related adverse events like cytokine release syndrome or neurotoxicity[5] - The company plans to enroll additional patients in the APOLLO trial and report further data in the second half of 2024[5] MT-601 (Pancreatic) The MT-601 pancreatic cancer program has FDA IND clearance, with clinical advancement contingent on securing additional non-dilutive funding - The FDA has cleared the Investigational New Drug (IND) application for a Phase 1 trial of MT-601 in patients with metastatic pancreatic cancer[5] - Clinical advancement for the pancreatic cancer program is contingent upon securing additional financial support through non-dilutive grant activities[5] MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic Syndrome) The AML program has shifted to an "Off-the-Shelf" MT-401-OTS product, which has received IND and Orphan Drug Designations, with clinical trials expected in H2 2024 - The company has shifted its AML program to focus on an "Off-the-Shelf" (OTS) product, MT-401-OTS, discontinuing the patient-specific approach to streamline resources[4] - MT-401-OTS has been granted an IND by the U.S. FDA and received Orphan Drug Designation from both the EMA and FDA[10] - Clinical program initiation for MT-401-OTS is anticipated in the second half of 2024, supported by $2 million in non-dilutive funding from an NIH SBIR grant[10] First Quarter 2024 Financial Results Marker Therapeutics reports its Q1 2024 financial performance, detailing cash position, reduced operating expenses, and a significantly lower net loss Financial Highlights Summary Marker Therapeutics held $11.3 million in cash as of March 31, 2024, projecting funding into Q4 2025, with reduced R&D and G&A expenses leading to a lower $2.4 million net loss - Cash and cash equivalents stood at $11.3 million as of March 31, 2024, which is expected to fund operating expenses into the fourth quarter of 2025[6] Q1 2024 vs. Q1 2023 Financial Comparison | Financial Metric | Q1 2024 ($) | Q1 2023 ($) | | :--- | :--- | :--- | | R&D Expenses | $2.6 million | $3.4 million | | G&A Expenses | $1.2 million | $2.2 million | | Net Loss | $2.4 million | $4.9 million | Condensed Consolidated Balance Sheets As of March 31, 2024, total assets were $14.1 million, a decrease from $17.1 million at year-end 2023, with total liabilities at $2.3 million and stockholders' equity at $11.8 million Balance Sheet Summary (Unaudited) | Balance Sheet Item | March 31, 2024 ($) | December 31, 2023 ($) | | :--- | :--- | :--- | | Cash and cash equivalents | $11,323,428 | $15,111,450 | | Total Assets | $14,091,899 | $17,127,391 | | Total Liabilities | $2,303,665 | $3,074,848 | | Total Stockholders' Equity | $11,788,234 | $14,052,543 | Condensed Consolidated Statements of Operations In Q1 2024, Marker Therapeutics reported $1.24 million in grant income and significantly reduced operating expenses to $3.8 million, resulting in a net loss of $2.4 million, or ($0.27) per share Statement of Operations Summary (Unaudited, For the Three Months Ended March 31) | Income Statement Item | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Grant income | $1,244,061 | $1,234,336 | | Total operating expenses | $3,793,078 | $5,543,815 | | Loss from operations | ($2,549,017) | ($4,309,479) | | Net loss | ($2,392,822) | ($4,967,576) | | Net loss per share, basic and diluted | ($0.27) | ($0.57) | Condensed Consolidated Statements of Cash Flows In Q1 2024, the company utilized $3.8 million in cash for operating activities, resulting in a $3.8 million decrease in cash and equivalents, ending the period at $11.3 million Statement of Cash Flows Summary (Unaudited, For the Three Months Ended March 31) | Cash Flow Item | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | ($3,837,118) | ($5,888,295) | | Net cash provided by financing activities | $49,096 | $619,974 | | Net decrease in cash and cash equivalents | ($3,788,022) | ($5,380,929) | | Cash and cash equivalents at end of period | $11,323,428 | $6,401,243 | About Marker Therapeutics Marker Therapeutics is a clinical-stage immuno-oncology company leveraging its multiTAA-specific T cell platform for cancer therapies, emphasizing financial discipline and non-dilutive funding About multiTAA-specific T cells Marker Therapeutics' core multiTAA-specific T cell platform is a non-genetically modified cell therapy designed to recognize a broad range of tumor antigens, offering potential advantages over engineered CAR-T and TCR therapies - The multiTAA-specific T cell platform is a novel, non-genetically modified cell therapy approach that expands tumor-specific T cells capable of recognizing a broad range of tumor antigens[8] - Marker believes its product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches[8] Company Overview Marker Therapeutics is a Houston-based clinical-stage immuno-oncology company developing T cell immunotherapies for cancers, prioritizing financial discipline and leveraging non-dilutive government funding - Marker Therapeutics is a clinical-stage immuno-oncology company focused on developing T cell-based immunotherapies for hematological malignancies and solid tumors[9] - The company prioritizes the preservation of financial resources and operational excellence, and its platform is supported by non-dilutive funding from U.S. state and federal agencies[9]