Marker Therapeutics(MRKR) - 2024 Q1 - Quarterly Report

PART I – FINANCIAL INFORMATION Financial Statements (Unaudited) Marker Therapeutics reported a net loss of $2.4 million for Q1 2024, a significant reduction from $5.0 million in Q1 2023, driven by lower operating expenses Condensed Consolidated Balance Sheets Total assets decreased to $14.1 million as of March 31, 2024, from $17.1 million at year-end 2023, primarily due to reduced cash and cash equivalents Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $11,323 | $15,111 | | Total current assets | $14,092 | $17,127 | | Total assets | $14,092 | $17,127 | | Liabilities and Stockholders' Equity | | | | Total current liabilities | $2,304 | $3,075 | | Total liabilities | $2,304 | $3,075 | | Total stockholders' equity | $11,788 | $14,053 | | Total liabilities and stockholders' equity | $14,092 | $17,127 | Condensed Consolidated Statements of Operations Net loss significantly decreased to $2.4 million in Q1 2024 from $5.0 million in Q1 2023, driven by reduced R&D and G&A expenses Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Grant income | $1,244 | $1,234 | | Total revenues | $1,244 | $1,234 | | Research and development | $2,575 | $3,376 | | General and administrative | $1,218 | $2,167 | | Total operating expenses | $3,793 | $5,544 | | Loss from operations | ($2,549) | ($4,309) | | Loss from continuing operations | ($2,393) | ($4,225) | | Loss from discontinued operations | $0 | ($743) | | Net loss | ($2,393) | ($4,968) | | Net loss per share | ($0.27) | ($0.57) | Condensed Consolidated Statements of Cash Flows Net cash used in operating activities was $3.8 million in Q1 2024, leading to a net decrease in cash and cash equivalents to $11.3 million Condensed Consolidated Statements of Cash Flows (in thousands) | | For the Three Months Ended March 31, 2024 | For the Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($3,837) | ($5,888) | | Net cash used in investing activities | $0 | ($113) | | Net cash provided by financing activities | $49 | $620 | | Net decrease in cash and cash equivalents | ($3,788) | ($5,381) | | Cash and cash equivalents at beginning of period | $15,111 | $11,782 | | Cash and cash equivalents at end of period | $11,323 | $6,401 | Notes to Condensed Consolidated Financial Statements Notes detail the company's immuno-oncology focus, the strategic shift from its 2023 asset sale, reliance on grant funding, and projected cash runway into Q4 2025 - The company is a clinical-stage immuno-oncology company focused on developing multiTAA-specific T cell immunotherapies[14] - In June 2023, the company sold its manufacturing facilities and related assets to Cell Ready, LLC for $19.0 million, treated as a discontinued operation and a significant strategic shift[15][16] - The company effected a 1-for-10 reverse stock split on January 26, 2023, reducing authorized common stock from 300 million to 30 million shares[21] - Based on current plans, the company expects its cash and cash equivalents of $11.3 million as of March 31, 2024, will fund operations into the fourth quarter of 2025[30] - In Q1 2024, the company incurred $1.2 million in expenses for services from Cell Ready, a related party, for GMP drug product manufacturing[72] Management's Discussion and Analysis of Financial Condition and Results of Operations Management attributes improved Q1 2024 financial results to significant cost reductions post-asset sale, focusing on advancing its clinical pipeline with outsourced manufacturing, while relying on external financing for future operations Company Overview and Pipeline Marker Therapeutics is a clinical-stage immuno-oncology company developing multiTAA-specific T cell therapies, with a pipeline including MT-601 and MT-401-OTS, offering advantages over CAR-T - The company specializes in multiTAA-specific T cell technology, which expands a patient's own tumor-specific T cells to recognize and kill cancer cells[78] - Key advantages cited over CAR-T therapies include targeting multiple tumor antigens, a strong clinical safety profile with no observed CRS, and a non-genetically engineered process reducing manufacturing complexity and cost[80][81] - The clinical pipeline features MT-601 (autologous) for lymphoma and pancreatic cancer, and MT-401-OTS (off-the-shelf) for various indications[80][84] - Recent data from the APOLLO study of MT-601 presented in April 2024 showed that participants tolerated the initial dose level well and demonstrated durable objective responses[83] Results of Operations Loss from continuing operations decreased 43% to $2.4 million in Q1 2024, driven by a 32% reduction in total operating expenses, including R&D and G&A Comparison of Operations for the Three Months Ended March 31 (in thousands) | | 2024 | 2023 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Grant income | $1,244 | $1,234 | $10 | 1% | | Research and development | $2,575 | $3,376 | ($801) | (24)% | | General and administrative | $1,218 | $2,167 | ($949) | (44)% | | Loss from continuing operations | ($2,393) | ($4,224) | $1,831 | (43)% | - The $0.8 million decrease in R&D expenses was mainly due to lower process development, clinical trial, and headcount costs, partially offset by a $1.2 million increase in outsourced clinical manufacturing costs with Cell Ready[107][108] - The $1.0 million decrease in G&A expenses was primarily driven by reduced headcount-related costs ($0.4 million) and lower legal and professional fees ($0.4 million)[108][109] Liquidity and Capital Resources The company's cash and cash equivalents decreased to $11.3 million by March 31, 2024, with current funds projected to last into Q4 2025, necessitating continued reliance on external financing Cash and Working Capital (in thousands) | | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $11,323 | $15,111 | | Working capital | $11,788 | $14,053 | - Net cash used in operating activities from continuing operations was $3.8 million for Q1 2024[113][114] - The company expects its cash on hand as of March 31, 2024, will fund operating expenses and capital requirements into the fourth quarter of 2025[124] - The company has access to capital through an ATM agreement, though its use is limited, selling 8,178 shares for net proceeds of $0.04 million in April 2024[128][73] - The company terminated its $25 million stock purchase agreement with Lincoln Park Capital on February 29, 2024[129] Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Marker Therapeutics is exempt from providing quantitative and qualitative disclosures about market risk - The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information under this item[131] Controls and Procedures Management concluded that disclosure controls and procedures were effective as of March 31, 2024, with no material changes to internal control over financial reporting during the quarter - Management evaluated disclosure controls and procedures and concluded they were effective as of the end of the period covered by the report[132] - There were no changes in internal control over financial reporting during the fiscal quarter ended March 31, 2024, that materially affected, or are reasonably likely to materially affect, internal controls[135] PART II – OTHER INFORMATION Legal Proceedings The company is not currently a party to any material legal proceedings, nor is it aware of any pending or threatened litigation - The company is not currently a party to any material legal proceedings[136] Risk Factors No material changes to the risk factors previously disclosed in the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 - There have been no material changes to the risk factors described in the Annual Report on Form 10-K for the fiscal year ended December 31, 2023[137] Unregistered Sales of Equity Securities and Use of Proceeds The company recorded no unregistered sales of equity securities during the three months ended March 31, 2024 - No issuances of unregistered securities were recorded during the three months ended March 31, 2024[138] Exhibits This section lists exhibits filed with the Form 10-Q, including CEO and CFO certifications and interactive data files - The report includes CEO and CFO certifications pursuant to Rule 13a-14(a) and Section 906 of the Sarbanes-Oxley Act of 2002[142] - The Master Services Agreement with Cell Ready LLC is incorporated by reference[142]