Marker Therapeutics(MRKR) - 2025 Q1 - Quarterly Report

PART I – FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) The unaudited condensed consolidated financial statements for Q1 2025 show decreased cash, increased net loss, and higher cash used in operations, reflecting reliance on external funding Condensed Consolidated Balance Sheets As of March 31, 2025, cash and total assets decreased, while total liabilities were reduced, leading to a decline in total stockholders' equity Condensed Consolidated Balance Sheet Data (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $13,693 | $19,192 | | Total current assets | $16,993 | $22,023 | | Total assets | $16,993 | $22,023 | | Total current liabilities | $2,501 | $3,464 | | Total liabilities | $2,501 | $3,464 | | Total stockholders' equity | $14,492 | $18,558 | Condensed Consolidated Statements of Operations For Q1 2025, grant income decreased by 72%, operating expenses increased to $5.0 million, resulting in a net loss of $4.4 million Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Grant Income | $349 | $1,244 | | Research and development | $3,135 | $2,575 | | General and administrative | $1,369 | $1,218 | | Loss on early termination of vendor agreement | $453 | $0 | | Loss from operations | $(4,609) | $(2,549) | | Net loss | $(4,446) | $(2,393) | | Net loss per share, basic and diluted | $(0.40) | $(0.27) | Condensed Consolidated Statements of Stockholders' Equity Stockholders' equity decreased from $18.6 million to $14.5 million due to a $4.4 million net loss, partially offset by stock-based compensation - The net loss of $4,446,184 was the main contributor to the reduction in stockholders' equity during the first quarter of 2025[11] - Stock-based compensation expense for Q1 2025 was $379,144, adding to paid-in capital[11] Condensed Consolidated Statements of Cash Flows Net cash used in operating activities increased to $5.5 million in Q1 2025, ending the quarter with $13.7 million in cash Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,500) | $(3,837) | | Net cash provided by financing activities | $0.5 | $49 | | Net decrease in cash and cash equivalents | $(5,499) | $(3,788) | | Cash and cash equivalents at end of period | $13,693 | $11,323 | Notes to Condensed Consolidated Financial Statements Key notes highlight the company's clinical-stage focus, liquidity concerns with funding into Q1 2026, termination of a vendor agreement, and reliance on grant income - The company is a clinical-stage immuno-oncology company focused on developing non-engineered, tumor-specific T cell therapies (MAR-T)[15] - On March 27, 2025, the company terminated its Master Services Agreement with Cell Ready, a related party, and paid a settlement of approximately $453,000[18] - Based on current cash of $13.7 million and operating plans, management anticipates funding requirements will be met into the first quarter of 2026, but these conditions raise substantial doubt about the company's ability to continue as a going concern[22][35] - The company has potential future milestone payments up to $64.85 million and royalty obligations to Baylor College of Medicine (BCM) upon commercialization of its products[83] - Total related party expenses for Q1 2025 were $1.665 million, primarily with Baylor College of Medicine and Cell Ready[86] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses MAR-T cell therapy development, a shift to third-party manufacturing, a widened net loss, and liquidity concerns with funding into Q1 2026 Company Overview and Pipeline Marker Therapeutics is a clinical-stage immuno-oncology company developing MAR-T cell therapies, with promising early Phase 1 APOLLO study data for MT-601 - The company is advancing two main product candidates: MT-601 (autologous) for lymphoma and pancreatic cancer, and MT-401-OTS (Off-the-Shelf)[100] - The Phase 1 APOLLO study of MT-601 in lymphoma reported promising efficacy with a 78% objective response rate and a 44.4% complete response rate in the first dose cohort[106] - MT-601 infusions were well-tolerated, with no observed ICANS and only one case of Grade 1 cytokine release syndrome (CRS)[106] Manufacturing The company has shifted to third-party manufacturing, terminating its agreement with Cell Ready, and is evaluating additional CDMOs for future needs - The company no longer operates its own cGMP manufacturing facility and relies on third parties for clinical and commercial supply[110] - The Master Services Agreement with CDMO Cell Ready was mutually terminated on March 27, 2025, with a settlement payment of approximately $453,000[111] - BCM continues to supply products for ongoing clinical trials, and the company is in the process of selecting additional CDMO partners for future needs[112] Results of Operations Q1 2025 saw a 72% decrease in grant income and a 31% increase in operating expenses, leading to an 86% wider net loss of $4.4 million Comparison of Operations for the Three Months Ended March 31 (in thousands) | Item | 2025 | 2024 | Change $ | Change % | | :--- | :--- | :--- | :--- | :--- | | Grant income | $349 | $1,244 | $(895) | (72)% | | Research and development | $3,135 | $2,575 | $560 | 22% | | General and administrative | $1,369 | $1,218 | $151 | 12% | | Loss on early termination | $453 | $0 | $453 | nm | | Total operating expenses | $4,957 | $3,793 | $1,164 | 31% | | Loss from operations | $(4,608) | $(2,549) | $(2,059) | 81% | | Net Loss | $(4,446) | $(2,393) | $(2,053) | 86% | - The increase in R&D expenses was primarily due to an $0.8 million increase in clinical trial expense and a $0.2 million increase in process development expenses, partially offset by a $0.6 million decrease in outsourced clinical manufacturing costs from Cell Ready[137] Liquidity and Capital Resources The company's $13.7 million cash is expected to fund operations into Q1 2026, but substantial doubt exists about its going concern ability without additional capital - The company anticipates its cash of $13.7 million as of March 31, 2025, will fund operating expenses and capital requirements into the first quarter of 2026[136][154] - Management has concluded that there is substantial doubt regarding the company's ability to continue as a going concern[166] - In December 2024, the company closed a private placement, raising net proceeds of approximately $14.9 million[33][164] - A new At The Market (ATM) Offering Agreement was established with H.C. Wainwright & Co. LLC in November 2024 for up to $11.4 million[24][163] Cash Flow and Working Capital (in thousands) | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $13,693 | $19,192 | | Working Capital | $14,492 | $18,558 | | Cash Flow (Q1) | 2025 | 2024 | | Net cash used in operating activities | $(5,500) | $(3,837) | Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Marker Therapeutics is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Marker Therapeutics is not required to provide quantitative and qualitative disclosures about market risk[169] Controls and Procedures Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal control over financial reporting - The company's principal executive officer and principal financial officer concluded that disclosure controls and procedures were effective as of the end of the period[170] - There were no material changes in internal control over financial reporting during the fiscal quarter ended March 31, 2025[172] PART II – OTHER INFORMATION Legal Proceedings The company is not currently a party to any material legal proceedings that could adversely affect its business or financial condition - The company reports no current material legal proceedings[174] Risk Factors No material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, have been reported - No material changes to the risk factors from the Annual Report on Form 10-K for the fiscal year ended December 31, 2024, have been reported[175] Unregistered Sales of Equity Securities and Use of Proceeds The company did not have any issuances of unregistered securities during the three months ended March 31, 2025 - No unregistered securities were issued during the first quarter of 2025[176] Other Information No director or officer adopted or terminated a Rule 10b5-1 trading plan or any non-Rule 10b5-1 trading arrangement during the quarter - No director or officer adopted or terminated any Rule 10b5-1 trading plans during the quarter[179] Exhibits This section lists the exhibits filed with the Form 10-Q, including certifications by the CEO and CFO and XBRL data files