Marker Therapeutics(MRKR) - 2025 Q2 - Quarterly Report

PART I – FINANCIAL INFORMATION This section provides the unaudited condensed consolidated financial statements and management's discussion and analysis for the interim period ended June 30, 2025 Item 1. Financial Statements (Unaudited) This section presents Marker Therapeutics' unaudited condensed consolidated financial statements for Q2 2025 and FY 2024, including balance sheets, statements of operations, stockholders' equity, cash flows, and explanatory notes on operations, liquidity, and accounting policies Condensed Consolidated Balance Sheets This section provides a snapshot of the company's financial position, detailing assets, liabilities, and stockholders' equity as of June 30, 2025, and December 31, 2024 | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $10,461,971 | $19,192,440 | | Restricted cash | $1,352,975 | — | | Total current assets | $14,767,870 | $22,022,860 | | Total assets | $14,767,870 | $22,022,860 | | Total current liabilities | $4,277,477 | $3,464,454 | | Total liabilities | $4,277,477 | $3,464,454 | | Total stockholders' equity | $10,490,393 | $18,558,406 | - Total assets decreased by approximately $7.25 million from December 31, 2024, to June 30, 2025, primarily driven by a decrease in cash and cash equivalents[7] - Total stockholders' equity decreased by approximately $8.07 million, largely due to the accumulated deficit[7] Condensed Consolidated Statements of Operations This section outlines the company's financial performance, presenting grant income, operating expenses, and net loss for the three and six months ended June 30, 2025 and 2024 | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Grant income | $861,184 | $1,169,236 | $1,210,288 | $2,413,297 | | Research and development | $4,177,054 | $2,335,430 | $7,312,481 | $4,910,446 | | General and administrative | $945,163 | $1,141,871 | $2,314,378 | $2,359,934 | | Loss on early termination | — | — | $453,135 | — | | Net loss | $(4,015,564) | $(2,192,677) | $(8,461,748) | $(4,585,499) | | Net loss per share (basic) | $(0.29) | $(0.25) | $(0.67) | $(0.51) | - Net loss increased significantly for both the three-month and six-month periods ended June 30, 2025, compared to the prior year, primarily driven by increased research and development expenses and a loss on early termination of a vendor agreement[9] - Grant income decreased by 26% for the three months and 50% for the six months ended June 30, 2025, compared to the same periods in 2024[9] Condensed Consolidated Statements of Stockholders' Equity This section details changes in the company's equity, including common stock, additional paid-in capital, and accumulated deficit, for the six months ended June 30, 2025 | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Common Stock Shares | 11,314,835 | 10,709,005 | | Additional Paid-in Capital | $465,958,006 | $465,564,876 | | Accumulated Deficit | $(455,478,926)| $(447,017,178) | | Total Stockholders' Equity | $10,490,393 | $18,558,406 | - The accumulated deficit increased by approximately $8.46 million during the six months ended June 30, 2025, reflecting the net loss for the period[11] - Common stock shares outstanding increased by 605,830 due to the exercise of prefunded warrants during the six months ended June 30, 2025[11] Condensed Consolidated Statements of Cash Flows This section summarizes the company's cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2025 and 2024 | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(7,378,099) | $(7,404,688) | | Net cash provided by financing activities | $605 | $93,702 | | Net (decrease) increase in cash, cash equivalents, and restricted cash | $(7,377,494) | $(7,310,986) | | Cash, cash equivalents, and restricted cash at end of period | $11,814,946 | $7,800,464 | - Net cash used in operating activities remained relatively stable year-over-year, at approximately $7.4 million for both periods[12] - Cash, cash equivalents, and restricted cash at the end of the period decreased by approximately $7.38 million in the first six months of 2025[12] Notes to Condensed Consolidated Financial Statements NOTE 1: NATURE OF OPERATIONS Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company focused on developing novel T cell-based immunotherapies, specifically Multi-Antigen Recognizing (MAR)-T cell technology, for hematological malignancies and solid tumors - Marker Therapeutics is a clinical-stage immuno-oncology company developing novel T cell-based immunotherapies[14] - The company's lead product, MT-601, is a Multi-Antigen Recognizing (MAR)-T cell therapy, with manufacturing services secured from Cellipont Bioservices for the APOLLO study[15][16] NOTE 2: BASIS OF PRESENTATION The unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP for interim financial information and SEC regulations, reflecting normal recurring adjustments - Financial statements are unaudited and prepared under U.S. GAAP for interim reporting, consistent with annual audited statements[17] - Interim results are not indicative of full-year or future periods and should be read with the December 31, 2024, Form 10-K[18] NOTE 3: LIQUIDITY AND FINANCIAL CONDITION As of June 30, 2025, the company had $11.8 million in cash, cash equivalents, and restricted cash, and anticipates funding operations into Q2 2026, raising substantial doubt about its ability to continue as a going concern - Cash, cash equivalents, and restricted cash totaled approximately $11.8 million as of June 30, 2025[19] - The company expects to fund operations into the second quarter of 2026, but this raises substantial doubt about its ability to continue as a going concern[32] - Management plans to raise additional capital through securities issuance and grants to extend funding beyond Q2 2026, though no assurance can be given[33] - Between July 17 and 21, 2025, the Company sold 1,624,075 shares of common stock via an ATM Agreement, generating net proceeds of $4.5 million[21] NOTE 4: SIGNIFICANT ACCOUNTING POLICIES There have been no material changes to the company's significant accounting policies since the December 31, 2024, Form 10-K, and new accounting pronouncements are not expected to have a material impact - No material changes to significant accounting policies since the last annual report[38] - The company operates as a single reportable segment, focusing on the discovery, development, and commercialization of immuno-oncology product candidates[46] - Recently issued accounting standards (ASU 2023-09 on Income Tax Disclosures and ASU 2024-03 on Expense Disaggregation) are not expected to have a material impact on financial statements[49][50] NOTE 5: NET LOSS PER SHARE The net loss per share for the three months ended June 30, 2025, was $(0.29) and for the six months was $(0.67), with all potentially dilutive securities being anti-dilutive | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(4,015,564) | $(2,192,677) | $(8,461,748) | $(4,585,499) | | Weighted average common shares outstanding, basic | 13,956,562 | 8,918,233 | 12,539,169 | 8,910,097 | | Net loss per share, basic and diluted | $(0.29) | $(0.25) | $(0.67) | $(0.51) | | Potentially Dilutive Securities | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------ | :----------------------------- | :----------------------------- | | Common stock options | 709,000 | 601,000 | | Common stock purchase warrants | 5,031,000 | — | | Total Potentially dilutive securities | 5,740,000 | 601,000 | - All potentially dilutive securities were anti-dilutive and excluded from the diluted net loss per share calculation for the periods presented[52] NOTE 6: OTHER RECEIVABLE The company recognizes grant income as revenue when qualifying costs are incurred, recording it as 'other receivable' if cash is not yet received, with significant receivables from CPRIT, Decoy, FDA, and PANACEA grants | Grant | Grant Income Receivable (June 30, 2025) | | :-------------------- | :------------------------------------ | | CPRIT AML Grant | $1.3 million | | Decoy Grant | $0.2 million | | FDA Grant | $0.1 million | | PANACEA Grant | $0.1 million | | SBIR AML Grant | $12,000 | - Qualifying grant income earned in advance of cash receipt is recorded as other receivable[53] NOTE 7: ACCOUNTS PAYABLE, ACCRUED LIABILITIES AND RELATED PARTY PAYABLE Total accounts payable, accrued liabilities, and related party payable decreased from $3.46 million at December 31, 2024, to $2.93 million at June 30, 2025, primarily due to a reduction in related party payable | Category | June 30, 2025 | December 31, 2024 | | :------------------------------------------ | :------------ | :---------------- | | Accounts payable | $1,715,000 | $1,066,000 | | Compensation and benefits | $65,000 | $86,000 | | Professional fees | $221,000 | $293,000 | | Related party payable | $657,000 | $1,711,000 | | Tax fees | $63,000 | $104,000 | | Other | $204,000 | $204,000 | | Total | $2,925,000 | $3,464,000 | - Related party payable decreased by over $1 million from December 31, 2024, to June 30, 2025, reflecting payments for outsourced product development and manufacturing services[58] NOTE 8: STOCKHOLDERS' EQUITY As of June 30, 2025, the company had 11.3 million common shares issued and outstanding, and total warrants outstanding decreased to 7.67 million due to the exercise of pre-funded warrants - 11.3 million common shares were issued and outstanding as of June 30, 2025, up from 10.7 million at December 31, 2024[7] | Warrant Type | Exercise Price Per Share | Expiration Date | Outstanding as of Dec 31, 2024 | Exercised | Outstanding as of Jun 30, 2025 | | :--------------------- | :----------------------- | :-------------- | :----------------------------- | :-------- | :----------------------------- | | Private placement warrants | $4.00 | March 21, 2030 | 5,031,250 | — | 5,031,250 | | Pre-funded warrants | $0.001 | March 21, 2030 | 3,247,445 | (605,830) | 2,641,615 | | Total | | | 8,278,695 | (605,830) | 7,672,865 | NOTE 9: STOCK-BASED COMPENSATION The company granted 140,000 stock options during the six months ended June 30, 2025, with total stock-based compensation expenses increasing to $393,000 due to a $0.3 million incremental expense from option modification | Metric | Six Months Ended June 30, 2025 | | :-------------------------- | :----------------------------- | | Number of Shares Outstanding (Dec 31, 2024) | 587,704 | | Granted | 140,000 | | Canceled/Expired | (18,443) |\ | Number of Shares Outstanding (Jun 30, 2025) | 709,261 | | Weighted Average Exercise Price (Jun 30, 2025) | $19.04 | | Stock Compensation Expenses | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $2,000 | $4,000 | $307,000 | $10,000 | | General and administrative | $12,000 | $59,000 | $86,000 | $132,000 | | Total | $14,000 | $63,000 | $393,000 | $142,000 | - An incremental stock-based compensation expense of $0.3 million was recognized immediately due to the modification and acceleration of unvested stock options for certain consultants[44][62] NOTE 10: GRANT INCOME The company recognized grant income from various sources, totaling $0.86 million for the three months and $1.21 million for the six months ended June 30, 2025, including a new $9.5 million CPRIT Pancreatic Grant | Grant Source | Grant Income (3 Months Ended Jun 30, 2025) | Grant Income (6 Months Ended Jun 30, 2025) | | :-------------------- | :----------------------------------------- | :----------------------------------------- | | CPRIT AML Grant | $0.3 million | $0.5 million | | CPRIT Pancreatic Grant | $0.2 million | $0.2 million | | FDA Grant | $0.1 million | $0.1 million | | SBIR AML Grant | $12,000 | $0.1 million | | Decoy Grant | $0.2 million | $0.2 million | | PANACEA Grant | $0.1 million | $0.1 million | - A $9.5 million CPRIT Pancreatic Grant was received in December 2024, with $1.4 million recorded as restricted cash and deferred revenue as of June 30, 2025[29][67] - Several funding agencies have agreed to shift financial support to the MT-401-OTS program[25] NOTE 11: COMMITMENTS AND CONTINGENCIES The company has revenue-sharing obligations with CPRIT grants and an exclusive license agreement with Baylor College of Medicine involving royalties and milestone payments, but is not currently involved in material legal proceedings - CPRIT grants include revenue-sharing arrangements, obligating the company to pay a percentage of net sales up to 400% of grant funds, and 0.5% thereafter[77] - The BCM License Agreement grants exclusive worldwide rights to MAR-T cell technology in exchange for common stock, royalties on commercial sales, and milestone payments up to $64.85 million[78] - The company is not currently a party to any legal proceedings that could have a material adverse effect on its business[79] NOTE 12: RELATED PARTY EXPENSES Related party expenses significantly increased for the six months ended June 30, 2025, primarily due to increased services and manufacturing costs from Baylor College of Medicine (BCM), and a $453,000 settlement payment for a terminated vendor agreement | Related Party | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Baylor College of Medicine | $1,868,000 | $6,000 | $2,488,000 | $6,000 | | Cell Ready | $63,000 | $650,000 | $1,080,000 | $1,836,000 | | Wilson Wolf Manufacturing Corporation | $21,000 | — | $50,000 | — | | Total Research and development | $1,952,000 | $656,000 | $3,618,000 | $1,842,000 | - Expenses related to BCM services and manufacturing costs increased substantially to $2.5 million for the six months ended June 30, 2025, from $6,000 in the prior year[81][85] - The Master Services Agreement with Cell Ready was mutually terminated on March 27, 2025, with a settlement payment of approximately $453,000[88] NOTE 13: SUBSEQUENT EVENTS Subsequent to the reporting period, the company sold 1.62 million common stock shares through an ATM Agreement in July 2025, generating $4.5 million in net proceeds - The company sold 1,624,075 shares of common stock via an ATM Agreement between July 17 and 21, 2025[89] - These sales generated net proceeds of $4.5 million, after deducting agent commissions, at an average price of $2.87 per share[89] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition and results of operations, highlighting its clinical-stage immuno-oncology focus, recent developments, detailed financial performance, and an assessment of its liquidity and capital resources, including a going concern warning Company Overview Marker Therapeutics is a clinical-stage immuno-oncology company developing non-genetically engineered Multi-Antigen Recognizing (MAR)-T cell therapies for hematological malignancies and solid tumors, with lead candidates MT-601 and MT-401-OTS showing promising early results in the APOLLO study - Marker Therapeutics specializes in novel T cell-based immunotherapies, utilizing non-genetically engineered MAR-T cell technology to target multiple tumor-associated antigens[93] - The company is advancing two product candidates: Autologous MAR-T cell (MT-601) for lymphoma and pancreatic cancer, and Off-the-Shelf (OTS) product (MT-401-OTS) for various indications[95] - Key findings from the Phase 1 APOLLO study for MT-601 in lymphoma patients include early objective responses (78% overall, 44.4% complete response) and a favorable safety profile with no ICANS or DLTs reported[99][100][101] - The company entered into a Statement of Work with Cellipont Bioservices for the manufacturing of MT-601 to support the APOLLO study and future commercial scale production[106] Recent Developments Recent developments include the company's agreement with Cellipont Bioservices for MT-601 manufacturing to support the APOLLO study and the sale of 1.62 million common stock shares through an ATM Agreement in July 2025, generating $4.5 million in net proceeds - On June 16, 2025, the company entered into a Statement of Work with Cellipont Bioservices for the manufacturing of MT-601 to support the APOLLO study[109] - Between July 17 and 21, 2025, the company sold 1,624,075 shares of common stock via an ATM Agreement, generating net proceeds of $4.5 million at an average price of $2.87 per share[110] Results of Operations The company experienced a significant increase in net loss for both the three and six months ended June 30, 2025, primarily due to a substantial rise in research and development expenses and a loss from the early termination of a vendor agreement Comparison of the Three months Ended June 30, 2025 and 2024 For the three months ended June 30, 2025, total revenues decreased by 26% to $0.86 million, while operating expenses increased by 47% to $5.12 million, resulting in an 83% increase in net loss to $(4.02) million | Metric | June 30, 2025 | June 30, 2024 | Change ($) | Change (%) | | :-------------------------- | :------------ | :------------ | :--------- | :--------- | | Grant income | $861,000 | $1,169,000 | $(308,000) | (26)% | | Total revenues | $861,000 | $1,169,000 | $(308,000) | (26)% | | Research and development | $4,177,000 | $2,335,000 | $1,842,000 | 79 % | | General and administrative | $945,000 | $1,142,000 | $(197,000) | (17)% | | Total operating expenses | $5,122,000 | $3,477,000 | $1,645,000 | 47 % | | Loss from operations | $(4,261,000) | $(2,308,000) | $(1,953,000)| 85 % | | Net loss | $(4,016,000) | $(2,193,000) | $(1,823,000)| 83 % | - The $1.8 million increase in R&D expenses was primarily due to a $1.7 million increase in clinical trial expenses and a $0.2 million increase in clinical consulting and other expenses[123] - General and administrative expenses decreased by $0.2 million, mainly due to lower legal and professional fees[125] Comparison of the Six months Ended June 30, 2025 and 2024 For the six months ended June 30, 2025, total revenues decreased by 50% to $1.21 million, operating expenses increased by 39% to $10.08 million, and the net loss increased by 85% to $(8.46) million | Metric | June 30, 2025 | June 30, 2024 | Change ($) | Change (%) | | :-------------------------------- | :------------ | :------------ | :--------- | :--------- | | Grant income | $1,210,000 | $2,413,000 | $(1,203,000)| (50)% | | Total revenues | $1,210,000 | $2,413,000 | $(1,203,000)| (50)% | | Research and development | $7,313,000 | $4,910,000 | $2,403,000 | 49 % | | General and administrative | $2,314,000 | $2,360,000 | $(46,000) | (2)% | | Loss on early termination of vendor agreement | $453,000 | — | $453,000 | — % | | Total operating expenses | $10,080,000 | $7,270,000 | $2,810,000 | 39 % | | Loss from operations | $(8,870,000) | $(4,857,000) | $(4,013,000)| 83 % | | Net loss | $(8,462,000) | $(4,585,000) | $(3,877,000)| 85 % | - The $2.4 million increase in R&D expenses was primarily due to a $1.9 million increase in clinical trial expense, a $0.3 million increase in clinical consulting, and a $0.1 million increase in process development costs[140][147] - The net loss increase was also impacted by a $453,000 loss on the early termination of the Cell Ready MSA[144] Liquidity and Capital Resources The company has historically financed operations through equity, debt, and grants, with no revenue from product sales, and anticipates funding operations into Q2 2026, raising substantial doubt about its going concern ability, prompting plans for additional capital raises and grant applications - The company has no revenue from product sales and relies on equity, debt, and grants for funding[145] - Cash, cash equivalents, and restricted cash were $11.8 million as of June 30, 2025, and with $4.5 million from July 2025 ATM sales, the company anticipates funding operations into Q2 2026[146][164] - These factors raise substantial doubt about the company's ability to continue as a going concern, leading management to consider additional capital raises and grant applications[146][174] - Working capital decreased from $18.6 million at December 31, 2024, to $10.5 million at June 30, 2025[163] Critical Accounting Estimates The company's critical accounting policy is grant income, recognized as revenue when qualifying costs are incurred, with no other critical accounting estimates identified - The company's critical accounting policy is grant income, recognized when qualifying costs are incurred[175][176] - No other critical accounting estimates are identified[175] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Marker Therapeutics, Inc. is exempt from providing quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide market risk disclosures[177] Item 4. Controls and Procedures Management, including the CEO and CFO, evaluated the effectiveness of the company's disclosure controls and procedures as of June 30, 2025, concluding they are effective, with no material changes in internal control over financial reporting - Management concluded that disclosure controls and procedures were effective as of June 30, 2025[178] - No material changes in internal control over financial reporting occurred during the fiscal quarter ended June 30, 2025[180] PART II – OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, defaults, other information, and exhibits for the interim period Item 1. Legal Proceedings The company is not currently a party to any legal proceedings that are believed to have a material adverse effect on its business, operating results, or financial condition - The company is not currently involved in any material legal proceedings[181] Item 1A. Risk Factors There have been 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 - No material changes to the risk factors described in the Annual Report on Form 10-K for the fiscal year ended December 31, 2024[182] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company did not record any issuances of unregistered securities during the three months ended June 30, 2025 - No unregistered sales of equity securities occurred during the three months ended June 30, 2025[183] Item 3. Defaults Upon Senior Securities The company reported no defaults upon senior securities during the period - No defaults upon senior securities were reported[184] Item 4. Mine Safety Disclosure This item is not applicable to the company - Mine Safety Disclosure is not applicable to the company[185] Item 5. Other Information On August 8, 2025, the Board of Directors increased Juan Vera's annual base salary from $400,000 to $440,000, with no director or officer adopting or terminating any Rule 10b5-1 trading plans during the quarter - The Board of Directors increased CEO Juan Vera's annual base salary from $400,000 to $440,000 on August 8, 2025[187] - No director or officer adopted or terminated any Rule 10b5-1 trading plans during the quarter ended June 30, 2025[187] Item 6. Exhibits This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including organizational documents, certifications, and XBRL interactive data files - The report includes certifications from the Chief Executive Officer and Chief Financial Officer (Exhibits 31.1, 31.2, 32.1, 32.2)[188] - XBRL Instance Document and Taxonomy Extension files are included as Exhibit 101[190] Signatures The report is signed on behalf of Marker Therapeutics, Inc. by Juan Vera, President, Chief Executive Officer, and Treasurer, on August 14, 2025 - The report was signed by Juan Vera, President, Chief Executive Officer and Treasurer, on August 14, 2025[194]