Core Insights - The Phase 1 APOLLO study by Marker Therapeutics shows that lymphodepletion enhances the expansion and persistence of MAR-T cells, potentially improving anti-tumor activity [1][4][5] - The study is focused on MT-601, a MAR-T cell product for patients with lymphoma who have relapsed after or are not candidates for anti-CD19 CAR-T cell therapy [2][9] - The company has reported a significant increase in patient enrollment, surpassing the total from the previous year within the first five months of 2025 [5][7] Company Overview - Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company based in Houston, TX, specializing in T cell-based immunotherapies for hematological malignancies and solid tumors [11] - The company was founded at Baylor College of Medicine and has conducted clinical trials involving over 200 patients, demonstrating well-tolerated and durable clinical responses [11] Study Details - The APOLLO trial is a multicenter, open-label study evaluating the safety and efficacy of MT-601 in participants with relapsed or refractory lymphoma [9] - The primary objective is to assess the optimum dose, safety, and preliminary efficacy of MT-601, with an expected enrollment of approximately 30 participants across nine clinical sites in the U.S. [9] Clinical Data - In the APOLLO study, MT-601 was well tolerated with no dose-limiting toxicities reported, achieving objective responses in 7 out of 9 patients (78%), including 4 complete responses (44.4%) [2][4] - Preliminary data indicates that lymphodepletion supports the expansion and persistence of MT-601 in vivo, with higher levels observed in patients undergoing lymphodepletion compared to those who did not [3][4] Future Outlook - The company anticipates sharing more meaningful clinical data by the end of summer 2025, driven by the increased pace of patient enrollment and positive early clinical results [5][7]

HOUSTON, May 19, 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 tumors, today announced that its Chief Executive Officer, Dr. Juan Vera, will participate in a live webcast produced by Demy-Colton in collaboration with the WBB Research Institute titled "Seven Years After FDA Approval – Have CD19 CAR-T Cells Met Expectations? ...

PART I – FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(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](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) 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](index=11&type=chunk) - Stock-based compensation expense for Q1 2025 was **$379,144**, adding to paid-in capital[11](index=11&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) 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](index=15&type=chunk) - 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](index=18&type=chunk) - 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](index=22&type=chunk)[35](index=35&type=chunk) - 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](index=83&type=chunk) - Total related party expenses for Q1 2025 were **$1.665 million**, primarily with Baylor College of Medicine and Cell Ready[86](index=86&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) 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](index=27&type=section&id=Company%20Overview%20and%20Pipeline) 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](index=100&type=chunk) - 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](index=106&type=chunk) - MT-601 infusions were well-tolerated, with no observed ICANS and only one case of Grade 1 cytokine release syndrome (CRS)[106](index=106&type=chunk) [Manufacturing](index=29&type=section&id=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](index=110&type=chunk) - The Master Services Agreement with CDMO Cell Ready was mutually terminated on March 27, 2025, with a settlement payment of approximately **$453,000**[111](index=111&type=chunk) - 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](index=112&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) 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](index=137&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) 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](index=136&type=chunk)[154](index=154&type=chunk) - Management has concluded that there is substantial doubt regarding the company's ability to continue as a going concern[166](index=166&type=chunk) - In December 2024, the company closed a private placement, raising net proceeds of approximately **$14.9 million**[33](index=33&type=chunk)[164](index=164&type=chunk) - 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](index=24&type=chunk)[163](index=163&type=chunk) 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](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) 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](index=169&type=chunk) [Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures.) 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](index=170&type=chunk) - There were no material changes in internal control over financial reporting during the fiscal quarter ended March 31, 2025[172](index=172&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings.) 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](index=174&type=chunk) [Risk Factors](index=45&type=section&id=Item%201A.Risk%20Factors.) 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](index=175&type=chunk) [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 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](index=176&type=chunk) [Other Information](index=45&type=section&id=Item%205.%20Other%20Information.) 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](index=179&type=chunk) [Exhibits](index=46&type=section&id=Item%206.%20Exhibits.) This section lists the exhibits filed with the Form 10-Q, including certifications by the CEO and CFO and XBRL data files

Financial Data and Key Metrics Changes - The company completed a public offering of common stock amounting to $56.5 million to support pipeline growth [5] - Cash and cash equivalents at the end of Q1 2021 were $64.5 million, expected to sustain operations into Q1 2023 [28] - Net loss for Q1 2021 was $8.8 million, an increase from a net loss of $6.5 million in Q1 2020 [28] - Research and development costs rose to $5.6 million in Q1 2021 from $3.8 million in Q1 2020, primarily due to increased headcount and infrastructure expenses [29] - General and administrative expenses increased to $3.1 million in Q1 2021 from $2.8 million in Q1 2020 [30] Business Line Data and Key Metrics Changes - The company initiated the safety lead-in portion of its Phase II trial for MT-401 in post-transplant acute myeloid leukemia (AML), treating the first patient in March 2021 [6][14] - The trial aims to enroll approximately six patients in the safety lead-in, with plans to open around 20 sites for the Phase II portion [15] - MT-401 has shown promising results in prior studies, with a 77% estimated two-year overall survival rate in patients post-infusion [18] Market Data and Key Metrics Changes - The company is focusing on the AML market, where current treatments have limited effectiveness, with only a 25% five-year survival rate for patients [6] - The MultiTAA therapy aims to address tumor heterogeneity and enhance immune response, potentially improving patient outcomes compared to existing therapies [12] Company Strategy and Development Direction - The primary focus for the year is completing the safety lead-in for the AML study and enrolling patients in the Phase II trial [10] - The company is optimizing its MT-401 cell therapy manufacturing process and plans to operationalize a new in-house facility [8] - The strategy includes exploring the application of manufacturing improvements across MultiTAA therapies to increase T cell availability [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of MT-401 in the AML patient population based on encouraging preliminary results [20] - The company is committed to addressing the unmet needs in cancer treatment and is exploring additional indications for future development [53] Other Important Information - The company has made significant technical and biological improvements in its manufacturing process, including a 50% reduction in manufacturing time and a 95% decrease in technical interventions [25][26] - The FDA has approved the changes in the manufacturing process, which are currently being implemented in the clinical study [27] Q&A Session Summary Question: Will there be disclosures after the safety lead-in trial? - Management indicated that safety data will be monitored and reported, with potential announcements regarding the main Phase II trial [32][33] Question: Could higher doses of MT-401 be used in the main Phase II trial? - Management confirmed that the new manufacturing process allows for the possibility of higher doses based on previous safety data [36][37] Question: How will manufacturing improvements impact cost and scalability? - Management noted that the simplified manufacturing process is expected to reduce costs and improve yield, making it suitable for future commercialization [43][44] Question: What are the next steps for collaboration with ABB on robotics? - Management expressed excitement about the collaboration, emphasizing the potential for improved consistency in the manufacturing process [49][50] Question: What are the key decision criteria for future indications? - Management highlighted the importance of unmet needs and data-driven decisions for exploring new indications beyond AML [53][54] Question: Update on Baylor's AML trial and higher dose testing? - Management stated that Baylor is nearing completion of the last dose level in their trial, with recent publications providing updates [58][60]

Summary of Marker Therapeutics Conference Call Company Overview - **Company**: Marker Therapeutics - **Industry**: Biotechnology, specifically focused on T cell therapies for cancer treatment Key Points and Arguments Clinical Trial Updates - **Phase II AML Trial**: Marker Therapeutics is advancing its Phase II trial for acute myeloid leukemia (AML) with its lead product candidate, MT-401, which is a multi TAA specific T cell therapy [4][5] - **Initial Results**: The safety lead-in portion of the trial showed a strong safety profile with no serious adverse events (SAEs) or neurotoxicity observed. One patient with measurable residual disease (MRD) converted to MRD negative status after treatment [5][6][25] - **Patient Demographics**: The trial plans to enroll approximately 180 patients, with a median age of 52, heavily pretreated with prior therapies [10][13] Manufacturing Process Improvements - **New Manufacturing Process**: A new T cell manufacturing process has been developed that reduces the manufacturing time to nine days, significantly improving potency and tumor-killing capabilities [7][28][33] - **Potency Increase**: The new process yields a product that is four times more potent based on antigen specificity compared to previous methods [30][33] - **Scalability**: The new process allows for pre-manufacturing of cell bank inventory, enabling faster delivery to patients within approximately 72 hours [39][40] Pipeline Expansion - **New Trials**: Marker plans to initiate three additional clinical trials over the next twelve months, including studies in pancreatic cancer and lymphoma, utilizing the new MT-601 product [43][44] - **Off-the-Shelf Products**: The company is expanding its pipeline to include off-the-shelf therapies, which will allow for broader patient access and treatment options [8][41] Safety and Efficacy - **Safety Profile**: No dose-limiting toxicities or cytokine release syndrome were noted in the safety lead-in results, consistent with previous studies [25][26] - **Efficacy in MRD Positive Patients**: The results support further investigation of MT-401 in AML patients, particularly in the MRD positive population, which currently lacks effective treatment options [25][84] Future Plans - **Clinical Goals**: The company aims to fully implement the new manufacturing process into the current AML study and complete dose escalation cohorts by Q3 2022 [45] - **IND Filings**: Plans to file Investigational New Drug (IND) applications for new studies are projected for the fourth quarter of 2022 [46] Additional Important Information - **Regulatory Considerations**: The company has worked closely with the FDA to ensure that the new manufacturing process meets regulatory standards for clinical studies and future commercialization [90] - **Patient Selection**: The company is cautious about identifying specific patient populations for therapy, emphasizing the need for further data to understand the therapy's effectiveness across different patient groups [80][82] This summary encapsulates the key points discussed during the Marker Therapeutics conference call, highlighting the company's advancements in clinical trials, manufacturing processes, and future plans in the biotechnology sector.

MAR-T Technology and Platform - MAR-T cells recognize up to 6 antigens for a potent anti-tumor response[18] - MAR-T cells lack genetic modification, posing no mutagenesis risk[18] - The MAR-T platform technology was developed at Baylor College of Medicine[18] - Marker Therapeutics was awarded over $30 million in non-dilutive funding to date[14] MT-601 (APOLLO Study) - MT-601 targets 6 tumor-specific antigens for broad tumor recognition[13, 17] - MT-601 in Phase 1 clinical trial has shown a 78% response rate in lymphoma patients who relapsed after anti-CD19 CAR-T cells or where CAR-T cell therapy is not an option[13] - In the APOLLO study, 7 out of 9 patients (78%) achieved objective responses at the first response assessment[31, 37] - 4 patients (44.4%) demonstrated complete response (CR) at first assessment in the APOLLO study[31] - MT-601 is an optimized MAR-T cell product with 4x increased potency compared to the Baylor study[27] Future Developments - The FDA granted an IND to investigate MT-401 in an "Off-the-Shelf" setting (MT-401-OTS) in AML or Myelodysplastic Syndrome (MDS)[36] - The FDA has granted an IND to investigate MT-601 in patients with metastatic pancreatic cancer in combination with front-line chemotherapy[36]

Core Insights - Marker Therapeutics, Inc. is participating in Canaccord Genuity's Horizons in Oncology Virtual Conference, focusing on innovations in T cell-based immunotherapies for cancer treatment [1][2]. Company Overview - Marker Therapeutics is a clinical-stage immuno-oncology company based in Houston, TX, specializing in next-generation T cell-based immunotherapies for hematological malignancies and solid tumors [5]. - The company 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 and show durable clinical responses [5]. - The company aims to introduce novel T cell therapies to the market while prioritizing financial resource preservation and operational excellence [5]. Panel Discussion Details - Dr. Juan Vera, CEO of Marker Therapeutics, will participate in a panel titled "CAR-T in Solid Tumors and New T-cell Approaches – Breakthroughs Ahead?" on April 7, 2025, from 11:00 AM to 11:50 AM ET [3]. - The panel will include discussions on the future of CAR-T therapies and other novel approaches in treating solid tumors [2][3]. Technology and Innovation - Marker Therapeutics is advancing a unique multi antigen recognizing (MAR)-T cell therapy platform designed to target multiple tumor-associated antigens simultaneously, showing promising clinical results in both hematologic malignancies and solid tumors [3].

Report Overview [Executive Summary](index=1&type=section&id=Marker%20Therapeutics%20Reports%20Year-End%202024%20Corporate%20and%20Financial%20Results) Marker Therapeutics reported significant progress in 2024 for its lead program, MT-601, demonstrating a 78% objective response rate in a Phase 1 lymphoma study. The company strengthened its financial position through over $13 million in non-dilutive funding and a strategic private placement, ensuring a cash runway into Q1 2026. Key operational achievements include receiving the nonproprietary name "neldaleucel" for MT-601 and preparing for clinical program launches for pancreatic cancer and AML in 2025 - The lead program, MT-601, showed a **78% objective response rate** and a favorable safety profile in a Phase 1 study for lymphoma patients who relapsed after anti-CD19 CAR-T cell therapy[1](index=1&type=chunk)[2](index=2&type=chunk) - Secured over **$13 million in non-dilutive funding** from CPRIT and NIH to support pancreatic and lymphoma clinical programs[1](index=1&type=chunk) - Strengthened financial position through a strategic private placement, with a focus on cash preservation and disciplined execution to advance clinical programs in 2025[2](index=2&type=chunk) - The nonproprietary name **"neldaleucel"** was approved for MT-601 by the USAN council and INN expert committee[1](index=1&type=chunk) Program Updates and Corporate Highlights [MT-601 (Lymphoma)](index=1&type=section&id=MT-601%20%28Lymphoma%29) The lead MAR-T cell therapy, MT-601 (neldaleucel), is being evaluated in the Phase 1 APOLLO study for relapsed lymphoma. Initial results from the first dose cohort of 9 patients are promising, showing a 78% objective response rate, including a 44.4% complete response rate. The therapy was well-tolerated with no dose-limiting toxicities or significant side effects like ICANS. Enrollment is ongoing, with further data expected in the second half of 2025 Phase 1 APOLLO Study Efficacy (First Dose Cohort) | Metric | Result | Patients (n=9) | | :--- | :--- | :--- | | **Objective Response Rate (ORR)** | 78% | 7 out of 9 | | **Complete Response (CR)** | 44.4% | 4 out of 9 | - MT-601 was well-tolerated, with no observed immune-effector cell associated neurotoxicity syndrome (ICANS) and only one case of Grade 1 cytokine release syndrome (CRS). No dose-limiting toxicities have been reported[3](index=3&type=chunk) - The company is continuing to enroll participants in the APOLLO trial and anticipates reporting additional data in the second half of 2025[5](index=5&type=chunk) [MT-601 (Pancreatic)](index=2&type=section&id=MT-601%20%28Pancreatic%29) The development of MT-601 for metastatic pancreatic cancer is supported by significant non-dilutive funding. The company received $2 million from the NIH SBIR and $9.5 million from CPRIT. The clinical program for this indication is expected to launch in the second half of 2025 - Received **$2 million from NIH SBIR** and **$9.5 million from CPRIT** to support the development of MT-601 in metastatic pancreatic cancer[5](index=5&type=chunk) - The clinical program launch for MT-601 in pancreatic cancer is anticipated in the second half of 2025[5](index=5&type=chunk) [MT-401-OTS (AML/MDS)](index=2&type=section&id=MT-401-OTS%20%28Acute%20Myeloid%20Leukemia%20or%20Myelodysplastic%20Syndrome%29) The company is advancing its "Off-the-Shelf" product, MT-401-OTS, for patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). This therapy is manufactured from healthy donors, and a cellular inventory has been established. The clinical program is expected to begin in the second half of 2025, supported by previously secured non-dilutive funding - MT-401-OTS is an **"Off-the-Shelf" product** manufactured from healthy donors, with an established cellular inventory[5](index=5&type=chunk) - Clinical program initiation for MT-401-OTS in AML/MDS is anticipated during the second half of 2025[5](index=5&type=chunk) [2024 Corporate Highlights](index=2&type=section&id=2024%20CORPORATE%20HIGHLIGHTS) In 2024, Marker Therapeutics strategically prioritized its clinical pipeline to focus on MT-601 in lymphoma. The company secured a $16.1 million private placement in December from new and existing investors to fund the advancement of the APOLLO study. Additionally, MT-601 was assigned the nonproprietary name "neldaleucel" - Announced a strategic focus on the **MT-601 program in lymphoma** in January 2024[5](index=5&type=chunk) - The nonproprietary (generic) name **"neldaleucel"** was approved for MT-601[5](index=5&type=chunk) - Completed a **$16.1 million private placement** on December 23, 2024, to support the clinical advancement of the Phase 1 APOLLO study[5](index=5&type=chunk) Fiscal Year 2024 Financials [Financial Performance Summary](index=3&type=section&id=Financial%20Summary) For the fiscal year ended December 31, 2024, Marker Therapeutics reported a net loss of $10.7 million. The company ended the year with $19.2 million in cash and cash equivalents, which is expected to fund operations into the first quarter of 2026. Research and development expenses increased to $13.5 million, while general and administrative expenses were significantly reduced to $4.2 million - As of December 31, 2024, the company had cash and cash equivalents of **$19.2 million**, providing a cash runway into the first quarter of 2026[6](index=6&type=chunk) Key Financial Metrics (Year-End) | Metric | 2024 ($ million) | 2023 ($ million) | Change ($ million) | | :--- | :--- | :--- | :--- | | **R&D Expenses** | $13.5 | $10.4 | +$3.1 | | **G&A Expenses** | $4.2 | $7.5 | -$3.3 | | **Net Loss** | $10.7 | $8.2 | +$2.5 | [Consolidated Balance Sheets](index=4&type=section&id=Marker%20Therapeutics%2C%20Inc.%20Consolidated%20Balance%20Sheets) As of December 31, 2024, Marker Therapeutics reported total assets of $22.0 million, an increase from $17.1 million in the prior year. This was primarily driven by a rise in cash and cash equivalents to $19.2 million. Total liabilities remained relatively stable at $3.5 million, while total stockholders' equity increased to $18.6 million from $14.1 million Consolidated Balance Sheet Highlights (Audited) | Account | Dec 31, 2024 ($) | Dec 31, 2023 ($) | | :--- | :--- | :--- | | **Cash and cash equivalents** | $19,192,440 | $15,111,450 | | **Total Assets** | $22,022,860 | $17,127,391 | | **Total Liabilities** | $3,464,454 | $3,074,848 | | **Total Stockholders' Equity** | $18,558,406 | $14,052,543 | [Consolidated Statements of Operations](index=5&type=section&id=Marker%20Therapeutics%2C%20Inc.%20Consolidated%20Statements%20of%20Operations) For the year ended December 31, 2024, the company's revenues, entirely from grant income, nearly doubled to $6.6 million from $3.3 million in 2023. Total operating expenses remained flat at approximately $17.7 million, as a $3.1 million increase in R&D was offset by a $3.3 million decrease in G&A. The loss from operations improved to $11.1 million from $14.6 million in the prior year. The reported net loss was $10.7 million, or ($1.19) per share, compared to a net loss of $8.2 million, or ($0.94) per share, in 2023, with the prior year benefiting from income from discontinued operations Consolidated Statement of Operations Highlights (Audited) | Account | For the Year Ended Dec 31, 2024 ($) | For the Year Ended Dec 31, 2023 ($) | | :--- | :--- | :--- | | **Grant Income** | $6,591,080 | $3,311,133 | | **Total Operating Expenses** | $17,709,452 | $17,892,511 | | **Loss from Operations** | ($11,118,372) | ($14,581,378) | | **Net Loss** | ($10,731,315) | ($8,236,814) | | **Net Loss Per Share** | ($1.19) | ($0.94) | [Consolidated Statements of Cash Flows](index=6&type=section&id=Marker%20Therapeutics%2C%20Inc.%20Consolidated%20Statements%20of%20Cash%20Flows) For the year ended December 31, 2024, net cash used in operating activities was $10.9 million. The company generated $15.0 million in net cash from financing activities, primarily from the issuance of common stock. This resulted in a net increase in cash of $4.1 million, bringing the year-end cash and cash equivalents balance to $19.2 million Consolidated Statement of Cash Flows Highlights (Audited) | Activity | For the Year Ended Dec 31, 2024 ($) | For the Year Ended Dec 31, 2023 ($) | | :--- | :--- | :--- | | **Net cash used in operating activities** | ($10,910,324) | ($16,439,961) | | **Net cash provided by investing activities** | $0 | $18,664,122 | | **Net cash provided by financing activities** | $14,991,314 | $1,105,117 | | **Net increase in cash** | $4,080,990 | $3,329,278 | | **Cash at end of period** | $19,192,440 | $15,111,450 | Company and Technology Overview [About MAR-T cells](index=3&type=section&id=About%20MAR-T%20cells) The company's core technology is the multi-antigen recognizing (MAR) T cell platform. It is a non-genetically modified cell therapy approach that expands a patient's own T cells to recognize a wide range of tumor antigens (up to six). This multi-target approach is designed to reduce the likelihood of tumor escape. Marker believes this method will be less expensive to manufacture and have an improved safety profile compared to current engineered T cell therapies - MAR-T is a novel, **non-genetically modified cell therapy** that expands T cells to recognize a broad range of tumor antigens[8](index=8&type=chunk) - The platform allows recognition of hundreds of epitopes within up to six tumor-specific antigens, reducing the potential for tumor escape[8](index=8&type=chunk) - Marker believes its product candidates will be easier and less expensive to manufacture with an improved safety profile compared to current engineered T cell therapies[8](index=8&type=chunk) [About Marker Therapeutics, Inc.](index=3&type=section&id=About%20Marker%20Therapeutics%2C%20Inc.) Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company based in Houston, TX, focused on developing next-generation T cell immunotherapies for hematological malignancies and solid tumors. Founded at Baylor College of Medicine, the company's therapies have been tested in over 200 patients, showing good tolerance and durable clinical responses. The company's strategy prioritizes financial discipline and operational excellence, leveraging non-dilutive funding from state and federal agencies - A clinical-stage immuno-oncology company specializing in **T cell-based immunotherapies** for hematological malignancies and solid tumors[9](index=9&type=chunk) - The company's strategy prioritizes the preservation of financial resources and focuses on operational excellence[9](index=9&type=chunk) - The T cell platform is strengthened by non-dilutive funding from U.S. state and federal agencies supporting cancer research[9](index=9&type=chunk)

Core Insights - Marker Therapeutics, Inc. has made significant advancements in its lead therapy MT-601, showing a 78% objective response rate in patients with refractory lymphomas, including durable complete responses [1][2] - The company secured over $13 million in non-dilutive funding from CPRIT and NIH to support its clinical programs for pancreatic and lymphoma treatments [1][2] - The USAN and INN committees approved "neldaleucel" as the nonproprietary name for MT-601, indicating progress in regulatory recognition [1][12] Program Updates - MT-601 is currently being evaluated in the Phase 1 APOLLO study for patients with anti-CD19 CAR-T relapsed lymphoma, with no reported dose-limiting toxicities and a favorable safety profile [5][12] - The APOLLO study reported that 7 out of 9 patients achieved objective responses, with 4 patients demonstrating complete responses [5] - The company plans to launch a clinical program for MT-601 in metastatic pancreatic cancer in the second half of 2025, supported by $2 million from NIH and $9.5 million from CPRIT [5][12] Financial Highlights - As of December 31, 2024, Marker Therapeutics had cash and cash equivalents of $19.2 million, which is expected to fund operations into Q1 2026 [7] - Research and development expenses increased to $13.5 million in 2024 from $10.4 million in 2023, while general and administrative expenses decreased to $4.2 million from $7.5 million [8] - The company reported a net loss of $10.7 million for the year ended December 31, 2024, compared to a net loss of $8.2 million in 2023 [8][17] Corporate Highlights - The company completed a $16.1 million private placement to support the clinical advancements of the Phase 1 APOLLO study, involving participation from notable investors [12] - Marker Therapeutics is focused on cash preservation and disciplined execution to maximize the impact of its clinical programs as it moves into 2025 [2][12] - The company aims to introduce novel T cell therapies to the market, prioritizing operational excellence and financial resource preservation [10]

Product Development - The company is advancing two product candidates for three clinical indications as part of its MAR-T cell program, including MT-601 for lymphoma and pancreatic cancer, and MT-401-OTS for various indications[20]. - The ongoing Phase 1/2 TACTOPS trial for MT-601 in pancreatic cancer showed a clinical benefit with 31% of patients (4 out of 13) demonstrating objective responses[29]. - The MT-401-OTS program aims to provide treatment to patients in as little as 72 hours, with the first patient expected to be dosed in the second half of 2025[35]. - The company aims to lead in the development and commercialization of transformative immunotherapies for hematological malignancies and solid tumors, significantly improving patient survival and quality of life[40]. - The company plans to prioritize the advancement of MT-601 in patients with lymphoma and advance the MT-401-OTS program in patients with AML and MDS based on positive Phase 1 clinical trial results[41]. - The company intends to initiate additional clinical trials in other tumor types based on emerging data from ongoing studies[42]. - The company has observed no dose-limiting toxicities, cytokine release syndrome, or neurotoxicity in its trials to date, indicating a favorable safety profile for its therapies[36]. - The company has experienced setbacks in clinical trials due to safety and efficacy concerns, which could lead to increased costs or abandonment of product candidates[210]. Clinical Trial Results - In the Phase 1 APOLLO study for MT-601, 78% of patients (7 out of 9) achieved objective responses at the first assessment, with a complete response rate of 44.4%[25]. - In a Phase 1 clinical trial for lymphoma, complete responses were observed in 6 out of 15 evaluable patients, with no relapses reported among those who achieved complete responses[60]. - The company reported an estimated two-year overall survival rate of 77% for patients treated with MAR-T cell therapy in a Phase 1 AML/MDS trial, compared to a two-year survival probability of 42% for risk-matched patients post-HSCT[67]. - In a Phase 1 clinical trial for lymphoma, 32 patients received MAR-T cell therapy, with 4 achieving objective responses and 1 achieving a complete response at month nine[74]. - Among 13 evaluable patients in the active lymphoma group, 6 experienced stable disease, and 9 exceeded historical overall survival rates[76]. - In the adjuvant lymphoma group, all 17 patients entered complete remission, with 14 maintaining remission without relapse, and response duration ranged from approximately 9 months to over 5 years[78]. Manufacturing and Production - The new T cell manufacturing process for MT-401 reduces production time to 9 days, allowing a 90% decrease in the number of interventions during production[36]. - The manufacturing process for MAR-T cell therapies has been optimized, reducing total manufacturing time from 36 days to 9 days, resulting in a four-fold increase in potency in vitro[43]. - The manufacturing process for MAR-T cell therapies involves isolating PBMCs and expanding T cells, resulting in an average of approximately 4,000 different T cell clonotypes per patient product[85]. - The standard dose for lymphoma patients ranges from 100 to 400 million cells per adult patient[86]. - The company has opened an in-house cGMP manufacturing facility in Houston, Texas, but has since sold its manufacturing assets to Cell Ready, LLC, and now relies on third-party vendors for clinical and commercial manufacturing[219]. - The company plans to evaluate and qualify additional third-party manufacturing partners in anticipation of a larger pivotal trial for lymphoma in 2026[90]. - The company has entered into a Master Services Agreement with Cell Ready for product supply, but this agreement was mutually terminated in March 2025[221]. - The manufacturing process is dependent on specialized equipment and materials, which may not be available on acceptable terms, impacting production capabilities[226]. Financials and Funding - The company incurred $5.8 million and $1.3 million in expenses related to services and manufacturing costs for the years ended December 31, 2024 and 2023, respectively[92]. - The company has a history of operating losses and expects these losses to continue indefinitely, raising substantial doubt about its ability to continue as a going concern[181]. - The company anticipates that its operational costs will increase significantly, leading to a growing deficit as it continues its clinical development program[181]. - The company plans to raise additional capital through the issuance of common shares and grant funds to fund operations beyond the first quarter of 2026[184]. - The company has sustained losses from operations in each fiscal year since inception, with expectations of continued losses due to substantial investments in research and development[183]. - The company currently carries product and clinical trial liability insurance, but there is no assurance that claims will not exceed coverage limits[171]. Regulatory and Compliance - The FDA granted orphan drug designation to MT-601 for pancreatic cancer treatment in January 2022, and the company received a $9.5 million grant from CPRIT and a $2 million grant from NIH to support clinical investigations[30]. - The FDA's review process for biologic product candidates typically involves a ten-month review for standard applications and six months for priority reviews after submission of a Biologics License Application (BLA)[139]. - The company must complete preclinical and clinical trials, including three phases of human clinical trials, before submitting a BLA for FDA approval[135]. - The FDA may require additional Phase 4 studies after product approval to monitor safety and efficacy, which could limit further marketing based on study results[141]. - The FDA offers expedited development programs, such as fast-track and breakthrough therapy designations, to facilitate the review process for products addressing serious conditions[142][143]. - The company must navigate various regulatory requirements for research, development, and marketing of its product candidates in multiple jurisdictions[132]. - The FDA closely regulates marketing and promotion of biologics, limiting claims to those approved in the product's labeling[154]. - Compliance with FDA regulations is mandatory post-approval, including record-keeping and reporting of adverse experiences[152]. Intellectual Property - The company’s intellectual property strategy focuses on obtaining and maintaining patent protection for its technologies, which is vital for its commercial success[120]. - The company’s patent portfolio includes claims directed to methods of generating multi-antigen specific T cell products and their therapeutic uses[117]. - The company is responsible for reimbursing BCM for patent-related expenses and maintaining all patent applications included in the licensed rights[102]. - The company has pending patent applications covering various medical technologies, but the outcome of these applications is uncertain, and they may face significant costs in opposition proceedings[126]. - The company relies on trade secrets and regulatory protections, such as orphan drug designations and data exclusivity, to maintain its proprietary position in immuno-oncology[128]. - The company retains ownership over any intellectual property developed under the CPRIT grant agreements, with a nonexclusive license granted to CPRIT for non-commercial use[112]. Market Competition - The company faces competition from multiple pharmaceutical and biotechnology companies, with a significant unmet medical need for effective treatments for relapsed lymphoma patients[95]. - The company’s MAR-T cell drug candidates may compete with various immunotherapies, including non-CD19 targeting CAR-T cells and bispecific antibodies[96]. - The company may face difficulties in patient enrollment for future clinical trials due to competition with other trials in the same therapeutic areas, which could delay trial completion and commercialization[209]. Operational Risks - The company is dependent on third-party vendors for manufacturing and cell processing, and disruptions could adversely affect operations[180]. - The reliance on third-party manufacturers poses risks, including potential delays in clinical trials and regulatory submissions if agreements are breached or terminated[224]. - The company may need to conduct additional studies if adverse side effects are identified during clinical trials, which could further delay regulatory approval[213]. - The company may not achieve projected development goals, potentially delaying product commercialization[208]. - Regulatory inspections may lead to temporary or permanent discontinuation of clinical trials if compliance issues are identified[204]. - Previous clinical trial results may not predict future outcomes, with potential setbacks occurring at any stage of the clinical trial process[205]. - The company may face challenges in recruiting suitable patients for clinical trials, which could delay the overall development timeline[202].