Marker Therapeutics initiated Phase 1 RAPID study to investigate Multi-Antigen Recognizing (MAR) T cells as an Off-the-Shelf (OTS) product to accelerate time to treatment OTS product was well tolerated - safety data consistent with other MAR-T cell studies HOUSTON, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tum ...

Summary of Marker Therapeutics FY Conference Call Company Overview - **Company**: Marker Therapeutics (NasdaqCM:MRKR) - **Focus**: Development and commercialization of next-generation T-cell-based immunotherapies for blood and solid tumor cancers using novel multi-TAA technology [1][4] Core Technology - **mar T-cell Technology**: Unique approach utilizing non-genetically engineered T cells to target multiple tumor-associated antigens (TAAs) through native T cell receptors, allowing recognition of a broad array of epitopes [4][6] - **Comparison with Other Technologies**: Unlike CAR T cells and bispecific antibodies, which are limited to specific targets, mar T cells can recognize intracellular proteins, providing a broader target profile and a better safety profile with minimal cytokine release syndrome and neurotoxicities [6][8] Market Need and Positioning - **Unmet Medical Need**: Focus on patients with diffuse large B-cell lymphoma (DLBCL) who have failed existing therapies (CAR T and bispecifics), representing a high unmet medical need [8][19] - **Product MT-601**: Positioned to fill this niche, with promising clinical data indicating a complete response rate of 50% and an overall response rate of 66% in heavily pretreated patients [19] Scalability and Manufacturing - **Manufacturing Process**: A simplified, non-genetically engineered manufacturing process that takes approximately 9 days, with a vein-to-vein time of 20 to 25 days, enhancing scalability and accessibility compared to CAR T therapies [10][31] - **Reproducibility**: Successful tech transfer across different vendors, ensuring consistent product quality and objective responses [31] Clinical Pipeline - **Lead Asset**: MT-601, currently in a Phase 1 Apollo trial focusing on DLBCL, with plans for a pivotal study anticipated to start early next year [24][30] - **Solid Tumor Indications**: Investigating MT-601 in pancreatic cancer due to high unmet need and promising preliminary results from prior studies [25][26] - **Off-the-Shelf Program**: Development of an off-the-shelf technology aimed at providing a readily available treatment option for patients [12][30] Safety and Efficacy - **Safety Profile**: Excellent tolerability observed even at the highest tested dose of 400 million cells, with minimal adverse effects reported [20][21] - **Lymph Node Depletion**: Incorporation of lymph node depletion in studies has shown to enhance T cell expansion and persistence without compromising safety [22][23] Future Milestones - **Upcoming Trials**: Continued updates on MT-601's clinical activity and safety, with first patient treatments in the off-the-shelf study and solid tumor program expected in the latter half of the year [30][32] - **Long-term Vision**: Potential expansion into solid tumors and development of off-the-shelf therapies, contingent on the success of the DLBCL program [32][33] Conclusion - **Investment Outlook**: The success of Marker Therapeutics is closely tied to the performance of MT-601 in DLBCL, with a clear strategy for addressing unmet needs in both hematologic and solid tumors [32][34]

Core Insights - Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company focused on developing next-generation T cell-based immunotherapies for hematological malignancies and solid tumors [4] Group 1: Event Participation - The CEO, Dr. Juan Vera, will participate in a fireside chat at the H.C. Wainwright 27 Annual Global Investment Conference from September 8-10, 2025 [1] - The fireside chat is scheduled for September 10, 2025, from 12:30 to 1:00 p.m. EDT at the Lotte New York Palace Hotel [2] - During the conference, Dr. Vera and the management team will hold one-on-one meetings with registered investors to discuss the Multi-Antigen Recognizing (MAR) T cell platform and clinical developments, including updates on the Phase 1 APOLLO study [2] Group 2: Company Overview - Marker Therapeutics was founded at Baylor College of Medicine and has conducted clinical trials involving over 200 patients, demonstrating that its autologous and allogeneic MAR-T cell products are well tolerated with durable clinical responses [4] - The company aims to introduce novel T cell therapies to the market to improve patient outcomes while prioritizing financial resource preservation and operational excellence [4] - Marker’s T cell platform benefits from non-dilutive funding from U.S. state and federal agencies supporting cancer research [4]

Core Insights - Marker Therapeutics, Inc. provided an update on the Phase 1 APOLLO study for MT-601, a Multi-Antigen Recognizing (MAR)-T cell product, targeting lymphoma patients who have relapsed after anti-CD19 CAR-T therapy or are not candidates for it [1][2] Efficacy and Response - The study reported a 66% objective response rate in Non-Hodgkin Lymphoma (NHL) patients, with 50% achieving a complete response [2][4] - Among 12 NHL patients treated, 8 showed objective responses, and 6 had a complete response, with durable responses lasting from 3 to 24 months [4] - In Hodgkin Lymphoma (HL) patients, 78% had objective responses, with one patient achieving a complete response [5] Safety Profile - The dose escalation study tested doses from 100×10^6 to 400×10^6 cells, showing no dose-limiting toxicities at the highest dose [6] - MT-601 was well tolerated, with no serious adverse events reported, and only two Grade 1 cytokine release syndrome events observed [6][7] - No differences in safety were noted between patients treated with or without lymphodepleting chemotherapy [7] Future Outlook - The company plans to provide another data update in the first half of 2026 [7]

Summary of Marker Therapeutics (MRKR) Update - August 26, 2025 Company Overview - **Company**: Marker Therapeutics - **Focus**: Development of MT-601, a T cell therapy for relapsed lymphoma, utilizing Marf T cell technology Key Points and Arguments Clinical Study Update - **Study**: Phase I APOLLO study of MT-601 in relapsed lymphoma - **Participants**: Patients with non-Hodgkin lymphoma, heavily pretreated with a median of five prior lines of treatment [16][40] - **Results**: - Complete Response (CR) rate of 50% and Overall Response Rate (ORR) of 66% in heavily pretreated patients [16] - Durability of responses: Three patients in complete response for over a year, five patients with clinical responses lasting more than six months [17] - In patients receiving the highest dose of 400 million cells, ORR was 78% and CR was 11% [18] Technology and Mechanism - **Technology**: Marf T cell technology developed at Baylor College of Medicine, capable of recognizing multiple tumor-associated targets without genetic modification [7][9] - **Manufacturing**: Collaboration with Cellipont for future pivotal studies and commercial launch, with a vein-to-vein time of 20-25 days [10][11] Safety Profile - **Safety Observations**: Excellent safety profile with no dose-limiting toxicities (DLTs) reported, and only mild cytokine release syndrome (CRS) observed [20] - **Comparison to CAR T therapies**: MT-601 does not require genetic modification, potentially reducing long-term risks associated with CAR T therapies [21] Competitive Landscape - **Current Treatments**: - Bispecific antibodies and CAR T therapies are the main treatments for DLBCL, but they have limitations in efficacy and durability [26][27] - Unmet needs persist for patients relapsing after CAR T or those ineligible for CAR T due to toxicity [26] - **Potential Positioning**: MT-601 could fill significant unmet needs in the treatment landscape, particularly for patients with DLBCL who have failed other therapies [31] Future Directions - **Next Steps**: Focus on dose expansion in DLBCL CAR relapse and bispecific relapse patients, aiming for pivotal study foundation [35] - **Regulatory Strategy**: Plans for accelerated approval based on strong clinical data and addressing high unmet medical needs [48] Additional Insights - **Patient Experiences**: Several case studies highlighted patients achieving complete metabolic responses after multiple prior therapies with minimal toxicity [24][25] - **Long-term Vision**: Potential to move MT-601 into earlier lines of treatment as more data becomes available [49] Important but Overlooked Content - **Manufacturing Process**: Emphasis on the autologous nature of the product and the strategic collaboration for manufacturing [10][11] - **Clinical Context**: The discussion on the overall survival rates for DLBCL CAR relapse patients, which is approximately five months, highlights the significance of the observed response durations with MT-601 [40] This summary encapsulates the critical aspects of the Marker Therapeutics update, focusing on the clinical study results, technology, safety profile, competitive landscape, and future directions.

Core Insights - The Phase 1 APOLLO study of MT-601 in patients with relapsed B cell lymphoma shows a 66% objective response rate in Non-Hodgkin Lymphoma (NHL) patients, with 50% achieving complete response (CR) [1][3] - The study demonstrates a favorable safety profile with no dose limiting toxicities (DLTs) or immune-effector cell associated neurotoxicity syndrome (ICANS) reported [1][8] - The next phase of the study will focus on patients with Diffuse Large B Cell Lymphoma (DLBCL) who have relapsed after or are ineligible for CAR-T cell therapy [1][10] Efficacy and Duration of Response - A total of 24 B-cell lymphoma patients have been treated, with 15 NHL and 9 Hodgkin Lymphoma (HL) patients showing objective responses [4] - Among 12 NHL patients, 8 achieved objective responses (66%), with 6 demonstrating CR (50%) and durable responses lasting from 3 to 24 months [6] - In HL patients, 7 out of 9 had objective responses (78%), with 1 patient achieving CR (11%) [7] Safety Profile - The study tested doses from 100x10 to 400x10 cells, with no DLTs reported at the highest dose [8] - Infusion of MT-601 was well tolerated, with only two Grade 1 cytokine release syndrome (CRS) events reported [8][9] - No serious adverse events were observed, reinforcing the safety of MT-601 [9] Study Design and Future Directions - The APOLLO study includes a dose escalation phase followed by a dose expansion phase, with the maximum dose of 400x10 cells cleared for further investigation [10] - The upcoming dose expansion will enroll patients with DLBCL who have relapsed after anti-CD19 CAR-T cells or are ineligible for such therapy [10] - The company anticipates providing another data update in the first half of 2026 [11] Company Overview - Marker Therapeutics, Inc. is focused on developing next-generation T cell-based immunotherapies for hematological malignancies and solid tumors [2][16] - The lead product, MT-601, is a multi-antigen recognizing (MAR) T cell product targeting six tumor antigens upregulated in lymphoma cells [13] - The company aims to improve patient outcomes through innovative T cell therapies while maintaining operational excellence and financial resource preservation [17]

[PART I – FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) 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)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(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](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=7&type=chunk) - Total stockholders' equity decreased by approximately **$8.07 million**, largely due to the accumulated deficit[7](index=7&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=9&type=chunk) - 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](index=9&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) 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](index=11&type=chunk) - Common stock shares outstanding increased by **605,830** due to the exercise of prefunded warrants during the six months ended June 30, 2025[11](index=11&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=12&type=chunk) - 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](index=12&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) [NOTE 1: NATURE OF OPERATIONS](index=8&type=section&id=NOTE%201:%20NATURE%20OF%20OPERATIONS) 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](index=14&type=chunk) - 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](index=15&type=chunk)[16](index=16&type=chunk) [NOTE 2: BASIS OF PRESENTATION](index=8&type=section&id=NOTE%202:%20BASIS%20OF%20PRESENTATION) 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](index=17&type=chunk) - Interim results are not indicative of full-year or future periods and should be read with the December 31, 2024, Form 10-K[18](index=18&type=chunk) [NOTE 3: LIQUIDITY AND FINANCIAL CONDITION](index=8&type=section&id=NOTE%203:%20LIQUIDITY%20AND%20FINANCIAL%20CONDITION) 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](index=19&type=chunk) - 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](index=32&type=chunk) - Management plans to raise additional capital through securities issuance and grants to extend funding beyond Q2 2026, though no assurance can be given[33](index=33&type=chunk) - 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](index=21&type=chunk) [NOTE 4: SIGNIFICANT ACCOUNTING POLICIES](index=13&type=section&id=NOTE%204:%20SIGNIFICANT%20ACCOUNTING%20POLICIES) 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](index=38&type=chunk) - The company operates as a single reportable segment, focusing on the discovery, development, and commercialization of immuno-oncology product candidates[46](index=46&type=chunk) - 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](index=49&type=chunk)[50](index=50&type=chunk) [NOTE 5: NET LOSS PER SHARE](index=17&type=section&id=NOTE%205:%20NET%20LOSS%20PER%20SHARE) 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](index=52&type=chunk) [NOTE 6: OTHER RECEIVABLE](index=17&type=section&id=NOTE%206:%20OTHER%20RECEIVABLE) 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](index=53&type=chunk) [NOTE 7: ACCOUNTS PAYABLE, ACCRUED LIABILITIES AND RELATED PARTY PAYABLE](index=19&type=section&id=NOTE%207:%20ACCOUNTS%20PAYABLE,%20ACCRUED%20LIABILITIES%20AND%20RELATED%20PARTY%20PAYABLE) 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](index=58&type=chunk) [NOTE 8: STOCKHOLDERS' EQUITY](index=19&type=section&id=NOTE%208:%20STOCKHOLDERS'%20EQUITY) 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](index=7&type=chunk) | 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](index=19&type=section&id=NOTE%209:%20STOCK-BASED%20COMPENSATION) 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](index=44&type=chunk)[62](index=62&type=chunk) [NOTE 10: GRANT INCOME](index=20&type=section&id=NOTE%2010:%20GRANT%20INCOME) 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](index=29&type=chunk)[67](index=67&type=chunk) - Several funding agencies have agreed to shift financial support to the MT-401-OTS program[25](index=25&type=chunk) [NOTE 11: COMMITMENTS AND CONTINGENCIES](index=21&type=section&id=NOTE%2011:%20COMMITMENTS%20AND%20CONTINGENCIES) 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](index=77&type=chunk) - 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](index=78&type=chunk) - The company is not currently a party to any legal proceedings that could have a material adverse effect on its business[79](index=79&type=chunk) [NOTE 12: RELATED PARTY EXPENSES](index=23&type=section&id=NOTE%2012:%20RELATED%20PARTY%20EXPENSES) 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](index=81&type=chunk)[85](index=85&type=chunk) - The Master Services Agreement with Cell Ready was mutually terminated on March 27, 2025, with a settlement payment of approximately **$453,000**[88](index=88&type=chunk) [NOTE 13: SUBSEQUENT EVENTS](index=24&type=section&id=NOTE%2013:%20SUBSEQUENT%20EVENTS) 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](index=89&type=chunk) - These sales generated net proceeds of **$4.5 million**, after deducting agent commissions, at an average price of **$2.87 per share**[89](index=89&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=26&type=section&id=Company%20Overview) 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](index=93&type=chunk) - 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](index=95&type=chunk) - 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](index=99&type=chunk)[100](index=100&type=chunk)[101](index=101&type=chunk) - 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](index=106&type=chunk) [Recent Developments](index=29&type=section&id=Recent%20Developments) 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](index=109&type=chunk) - 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](index=110&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) 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](index=29&type=section&id=Comparison%20of%20the%20Three%20months%20Ended%20June%2030,%202025%20and%202024) 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](index=123&type=chunk) - General and administrative expenses decreased by **$0.2 million**, mainly due to lower legal and professional fees[125](index=125&type=chunk) [Comparison of the Six months Ended June 30, 2025 and 2024](index=32&type=section&id=Comparison%20of%20the%20Six%20months%20Ended%20June%2030,%202025%20and%202024) 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](index=140&type=chunk)[147](index=147&type=chunk) - The net loss increase was also impacted by a **$453,000** loss on the early termination of the Cell Ready MSA[144](index=144&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) 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](index=145&type=chunk) - 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](index=146&type=chunk)[164](index=164&type=chunk) - 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](index=146&type=chunk)[174](index=174&type=chunk) - Working capital decreased from **$18.6 million** at December 31, 2024, to **$10.5 million** at June 30, 2025[163](index=163&type=chunk) [Critical Accounting Estimates](index=44&type=section&id=Critical%20Accounting%20Estimates) 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](index=175&type=chunk)[176](index=176&type=chunk) - No other critical accounting estimates are identified[175](index=175&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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](index=177&type=chunk) [Item 4. Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=178&type=chunk) - No material changes in internal control over financial reporting occurred during the fiscal quarter ended June 30, 2025[180](index=180&type=chunk) [PART II – OTHER INFORMATION](index=45&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, defaults, other information, and exhibits for the interim period [Item 1. Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) 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](index=181&type=chunk) [Item 1A. Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) 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](index=182&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=45&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) 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](index=183&type=chunk) [Item 3. Defaults Upon Senior Securities](index=45&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - No defaults upon senior securities were reported[184](index=184&type=chunk) [Item 4. Mine Safety Disclosure](index=45&type=section&id=Item%204.%20Mine%20Safety%20Disclosure) This item is not applicable to the company - Mine Safety Disclosure is not applicable to the company[185](index=185&type=chunk) [Item 5. Other Information](index=45&type=section&id=Item%205.%20Other%20Information) 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](index=187&type=chunk) - No director or officer adopted or terminated any Rule 10b5-1 trading plans during the quarter ended June 30, 2025[187](index=187&type=chunk) [Item 6. Exhibits](index=46&type=section&id=Item%206.%20Exhibits) 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](index=188&type=chunk) - XBRL Instance Document and Taxonomy Extension files are included as Exhibit 101[190](index=190&type=chunk) [Signatures](index=48&type=section&id=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](index=194&type=chunk)

Summary of Conference Call on Marker Therapeutics Company Overview - **Company**: Marker Therapeutics - **Industry**: Biotech, specifically focused on cancer immunotherapy Core Technology and Approach - **MAR T Cell Approach**: Marker Therapeutics utilizes a unique MarT cell approach that targets tumors in cancer, differing from traditional CAR T cells and alpha beta TCRs by recognizing multiple epitopes across various tumor-associated antigens [2][3] - **Mechanism of Action**: The product employs natural T cell receptors to recognize hundreds of epitopes across six different tumor-associated antigens, enhancing the ability to target complex tumor microenvironments and avoid immune escape [2][3] - **Manufacturing Process**: The manufacturing process is a simple nine-day ex vivo procedure that does not involve genetic modification, relying instead on peptide stimulation to raise an immune response [5][6] Clinical Data and Pipeline - **Lead Asset**: MT601 is the lead asset, currently being advanced for approval in lymphoma (DLBCL) and solid tumors, including pancreatic cancer [12][13] - **Clinical Results**: The clinical data from Baylor College of Medicine shows an overall response rate of 77% and a complete response (CR) rate of 44% in lymphoma patients, with some patients showing durability beyond six months [15][16] - **Market Opportunity**: Approximately 8,000 lymphoma patients treated with CAR T cells in 2024, with an estimated 40-60% expected to relapse, creating a potential market opportunity of about $1.7 billion annually for MT601 [21][22] Competitive Landscape - **Current Treatment Limitations**: Existing treatments for relapsed patients, such as bispecifics, have significant limitations including toxicity and lack of curative potential, indicating a high unmet medical need for effective therapies [18][20] - **Differentiation**: Marker Therapeutics' approach is distinct due to its target-agnostic strategy, allowing for enrollment without prior tumor biopsy, and its favorable safety profile compared to existing CAR T therapies [8][39] Future Directions - **Expansion into Solid Tumors**: The company is exploring the use of MT601 in solid tumors, supported by government funding, which could provide a significant growth opportunity [34][35] - **Off-the-Shelf Approach**: Development of a cellular inventory for rapid patient treatment is underway, with the first patient expected to be treated in the latter half of the year [35] Financial Position - **Cash Position**: As of March 31, the company reported cash and cash equivalents of $13.7 million, extending its runway into the first quarter of the following year [48][49] - **Government Funding**: The company has secured over $30 million in government funding, which supports its operations and validates its technology [48][49] Conclusion - Marker Therapeutics is positioned uniquely within the biotech industry with its innovative MarT cell approach, promising clinical data, and significant market opportunities in treating relapsed lymphoma and solid tumors. The company is actively working to differentiate itself from competitors while maintaining a strong financial position through government support.

Core Insights - Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company focused on developing next-generation T cell-based immunotherapies for hematological malignancies and solid tumors [4] - The CEO, Dr. Juan Vera, will participate in a fireside chat at the Canaccord Genuity 45 Annual Growth Conference from August 12-14, 2025 [1][2] - The company aims to introduce novel T cell therapies to the market and improve patient outcomes while preserving financial resources and focusing on operational excellence [4] Event Details - The fireside chat is scheduled for August 12, 2025, from 12:30 to 12:55 p.m. EDT at the InterContinental Boston Hotel [2] - During the conference, Dr. Vera and the management team will hold one-on-one meetings with registered investors to discuss the Multi-Antigen Recognizing (MAR) T cell platform and clinical developments [2] - Investors can access the event online through the company's Investor Relations website [3] Company Background - Marker Therapeutics was founded at Baylor College of Medicine and has conducted clinical trials involving over 200 patients, demonstrating that its MAR-T cell products are well tolerated and show durable clinical responses [4] - The company benefits from non-dilutive funding from U.S. state and federal agencies supporting cancer research, which strengthens its unique T cell platform [4]

Core Insights - Marker Therapeutics, Inc. announced a collaboration with Cellipont Bioservices for the cGMP manufacturing of MT-601, a leading MAR-T cell therapy aimed at treating hematological malignancies and solid tumors [1][3] Company Overview - Marker Therapeutics is a clinical-stage immuno-oncology company based in Houston, TX, focusing on next-generation T cell-based immunotherapies for hematological malignancies and solid tumors [6] - The company has conducted clinical trials involving over 200 patients, demonstrating that its autologous and allogeneic MAR-T cell products are well tolerated and show durable clinical responses [6] Clinical Development - MT-601 is currently in the Phase 1 APOLLO study targeting patients with lymphoma who have relapsed after anti-CD19 CAR-T cell therapy or are ineligible for it, with a reported 78% objective response rate and 44.4% complete response rate among participants [2] - The collaboration with Cellipont aims to support the scale-up and production of MT-601, facilitating clinical supply and potential pivotal trials [3][4] Manufacturing Partnership - Cellipont Bioservices will provide technology transfer and cGMP manufacturing services to Marker Therapeutics, leveraging its state-of-the-art facility designed for high-quality cell therapy production [3][4] - The partnership is expected to enhance the clinical development and future commercial production capabilities for MT-601 [4][5] Strategic Importance - The collaboration is viewed as a critical step for Marker Therapeutics in preparing for potential pivotal trials, particularly for patients with diffuse large B-cell lymphoma [4] - Both companies emphasize a shared commitment to quality and innovation in advancing next-generation immunotherapies [5]