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Clinical Development - MT-601 achieved a 66% objective response rate and a 50% complete response rate in relapsed Non-Hodgkin lymphoma patients during the APOLLO study[4] - The first patient was treated in the Off-the-Shelf (OTS) program investigating MAR-T cells for Acute Myeloid Leukemia or Myelodysplastic Syndrome[4] - The company anticipates additional clinical data from the APOLLO study in the first half of 2026[8] - Marker was awarded $2.0 million from the NIH and $9.5 million from CPRIT to support the development of MT-601 in metastatic pancreatic cancer[8] Financial Performance - The net loss for Q3 2025 was $2.0 million, an improvement from a net loss of $2.3 million in Q3 2024[11] - For the nine months ended September 30, 2025, the net loss was $10,460,410, compared to a net loss of $6,893,691 for the same period in 2024, indicating an increase in losses of approximately 51%[21] - Net cash used in operating activities for the nine months ended September 30, 2025, was $10,113,975, up from $6,207,189 in 2024, reflecting a 63% increase in cash outflow[21] - Cash, cash equivalents, and restricted cash at the end of the period were $18,942,953, a decrease from $19,192,440 at the beginning of the period[21] - The net decrease in cash, cash equivalents, and restricted cash for the nine months ended September 30, 2025, was $249,487, compared to a much larger decrease of $6,111,786 in 2024[21] Expenses - Research and development expenses for Q3 2025 were $2.3 million, down from $3.5 million in Q3 2024[10] - General and administrative expenses for Q3 2025 were $1 million, compared to $0.9 million in Q3 2024[10] - The company reported stock-based compensation of $426,409 for the nine months ended September 30, 2025, compared to $195,320 in 2024, representing a 118% increase[21] Cash Management - The company raised approximately $10 million through its ATM facility, extending its cash runway into 2026[4] - As of September 30, 2025, Marker had cash and cash equivalents of $17.6 million and restricted cash of $1.4 million, expected to fund operations through Q3 2026[9] - The company raised $9,863,883 from the issuance of common stock during the nine months ended September 30, 2025, compared to $36,902 in 2024, showing a significant increase in financing activities[21] Other Financial Metrics - Deferred revenue increased to $1,352,975 for the nine months ended September 30, 2025, indicating potential future revenue recognition[21] - The company experienced a significant change in accounts payable and accrued expenses, which decreased by $901,449 from the previous year[21] - Proceeds from the exercise of warrants and stock options were $605 for the nine months ended September 30, 2025, down from $58,501 in 2024, indicating a decline in stock option activity[21] - Other receivables increased to $681,550 for the nine months ended September 30, 2025, compared to $283,405 in 2024, reflecting improved collection or new receivables[21] Manufacturing Collaboration - Marker entered a cGMP manufacturing collaboration with Cellipont Bioservices to scale up production of MT-601[2]

Core Insights - Marker Therapeutics reported promising results from the Phase 1 APOLLO study, showing a 66% objective response rate and 50% complete response rate in relapsed Non-Hodgkin lymphoma patients, indicating the potential of MT-601 as a treatment option for patients with limited therapy options [2][5] - The company has initiated its Off-the-Shelf program, treating the first patient in the RAPID study, which focuses on MAR-T cells for Acute Myeloid Leukemia and Myelodysplastic Syndrome [2][12] - A strategic manufacturing collaboration with Cellipont Bioservices has been established to enhance the production capabilities of MT-601, supporting clinical supply and future pivotal trials [2][12] Clinical Updates - The APOLLO study demonstrated durable responses, with five patients maintaining responses for at least six months, and three for over twelve months [5] - No dose-limiting toxicities or immune effector cell-associated neurotoxicity were observed, highlighting a favorable safety profile for MT-601 [5] - The ongoing dose expansion cohort is evaluating MT-601 at the highest dose level in patients with Diffuse Large B Cell Lymphoma who have relapsed or are ineligible for CAR-T therapy [5] Financial Highlights - As of September 30, 2025, Marker Therapeutics had cash and cash equivalents of $17.6 million and restricted cash of $1.4 million, which is expected to fund operations through the third quarter of 2026 [8] - Research and development expenses for Q3 2025 were $2.3 million, a decrease from $3.5 million in Q3 2024, while general and administrative expenses increased slightly to $1 million from $0.9 million [9] - The company reported a net loss of $2.0 million for Q3 2025, compared to a net loss of $2.3 million in the same quarter of the previous year [10] Corporate Developments - Marker Therapeutics raised approximately $10 million through its ATM facility, extending its cash runway into 2026 [2][12] - The company has received non-dilutive funding from NIH and CPRIT to support the development of MT-601 in metastatic pancreatic cancer, with a clinical program launch anticipated in the first half of 2026 [5][12] - The appointment of Kathryn Penkus Corzo to the Board of Directors was announced, effective November 1, 2025 [12]

Financial Performance - Total revenues for the three months ended September 30, 2025, were $1,233,000, a decrease of 36% compared to $1,926,000 in the same period of 2024[122]. - Total revenues for the nine months ended September 30, 2025 were $2.4 million, a decrease of 44% from $4.3 million in 2024[139]. - The net loss for the nine months ended September 30, 2025 was $10.5 million, an increase of 52% from a net loss of $6.9 million in 2024[139]. Research and Development - Research and development expenses decreased by 32% to $2,346,000 for the three months ended September 30, 2025, compared to $3,471,000 in 2024[122]. - Research and development expenses increased by 15% to $9.7 million for the nine months ended September 30, 2025, compared to $8.4 million in 2024[152]. - The company has a pipeline that includes two product candidates for three clinical indications as part of the MAR-T cell program[105]. Clinical Trials and Studies - Eight out of 12 Non-Hodgkin Lymphoma (NHL) patients achieved objective responses (66%) in the Phase 1 APOLLO study, with 50% demonstrating complete response (CR)[111]. - The company reported no treatment-related side effects in the APOLLO study, indicating a favorable safety profile for the MAR-T cell therapy[110]. - The company entered into a Statement of Work with Cellipont Bioservices for the manufacturing of MT-601, supporting the scale-up for the APOLLO study[114]. Grants and Funding - The company received a $2.0 million grant from the NIH SBIR program in August 2024 to support MT-601 for pancreatic cancer, recognizing approximately $0.2 million in revenue for the nine months ended September 30, 2025[129]. - An additional $9.5 million grant from CPRIT was awarded in December 2024 for MT-601 in metastatic pancreatic cancer, with $1.4 million recorded as restricted cash and deferred revenue as of September 30, 2025[130]. - The Company received a total of $2.0 million in grants from the NIH SBIR program to support the development of MT-401 for AML patients, with $1.5 million received to date[170]. Operating Expenses - Operating expenses for the three months ended September 30, 2025 were $3.4 million, a decrease of 21% from $4.3 million in the same period in 2024[131]. - Operating expenses for the three and nine months ended September 30, 2025, were $3.4 million and $13.4 million, respectively, compared to $4.3 million and $11.6 million in the prior year periods[177]. - General and administrative expenses increased by 20% to $1.0 million for the three months ended September 30, 2025, primarily due to headcount-related expenses[135]. Stock and Capital - The company sold 1,624,075 shares of common stock for net proceeds of $4.5 million at an average price of $2.87 per share between July 17 and 21, 2025[119]. - An additional 3,734,217 shares were sold for net proceeds of $5.4 million at an average price of $1.48 per share on August 26, 2025[176]. - The Company plans to continue funding operations through equity and/or debt financing, which may dilute existing stockholders' interests[179]. Future Outlook - The company anticipates continued net losses as it invests in research and development activities, including clinical development of MAR-T cell product candidates[138]. - The company expects to fund its operating expenses through the third quarter of 2026, assuming no additional grant funds are received[159]. - High inflation and economic recession concerns may negatively affect the Company's liquidity and ability to access capital[180].

Core Viewpoint - Marker Therapeutics, Inc. has appointed Kathryn Penkus Corzo to its Board of Directors, effective November 1, 2025, to strengthen its leadership as it advances its clinical programs, particularly the APOLLO program for CAR-relapsed Diffuse Large B Cell Lymphoma (DLBCL) [1][4]. 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 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 [6]. Leadership Appointment - Kathryn Penkus Corzo brings over 30 years of experience in biopharma, including roles in R&D, clinical trials, regulatory approvals, and commercialization [2]. - Prior to joining Marker, she served as President and COO at bit.bio Ltd, where she expanded the company's product portfolio and established scalable operations [2]. - Corzo has held senior positions at Takeda Ventures, Sanofi Genzyme, Hoffmann-La Roche, Eli Lilly, and Syndax Pharmaceuticals, contributing to the development and launch of multiple global blockbuster cancer therapies [3]. Clinical Development Focus - Marker Therapeutics is committed to advancing its lead asset MT-601 and the APOLLO program, which targets CAR-relapsed DLBCL [4]. - The company emphasizes the potential of its Multi-Antigen Recognizing (MAR) T cell platform, which aims to address limitations of current treatments and improve clinical outcomes for patients with limited options [5]. MAR-T Cell Platform - The MAR-T cell platform is a novel, non-genetically modified cell therapy that selectively expands tumor-specific T cells capable of recognizing a broad range of tumor antigens [5]. - This approach allows recognition of hundreds of different epitopes within up to six tumor-specific antigens, potentially reducing the risk of tumor escape [5]. - Marker believes that its MAR-T cell products will be easier and less expensive to manufacture, with an improved safety profile compared to current engineered T cell therapies [5].

Core Insights - The Phase 1 APOLLO study of MT-601 in patients with relapsed B cell lymphomas has shown promising preliminary efficacy and a robust safety profile [1][2][3] Study Findings - MT-601 demonstrated an objective response rate (ORR) of 66% in Non-Hodgkin lymphoma (NHL) patients, with 50% achieving a complete response (CR) [2] - In Hodgkin lymphoma (HL), the ORR was 78%, with 11% achieving a CR [2] - Responses in NHL were durable, lasting from 3 to 24 months, with five patients remaining in remission for 6 months or longer [2] - The study reported no dose limiting toxicities (DLTs) or immune-effector cell associated neurotoxicity syndrome (ICANS) [1][2] Next Steps - The company has advanced to the dose expansion phase, evaluating MT-601 at the highest dose level (400x10 cells) in patients with Diffuse Large B Cell Lymphoma (DLBCL) [3] Presentation Details - Two posters will be presented at the 67th American Society of Hematology (ASH) Annual Meeting, detailing the safety and efficacy of MT-601 in relapsed or refractory Hodgkin and Non-Hodgkin lymphoma [4] About MT-601 - MT-601 is a multi-antigen recognizing (MAR) T cell therapy targeting six tumor antigens upregulated in lymphoma cells [5][6] - The therapy is being investigated for patients who have relapsed after or are not candidates for anti-CD19 CAR-T cell therapies [5][6] About APOLLO Trial - The APOLLO trial is a multicenter, open-label study designed to evaluate the safety and efficacy of MT-601 in participants with relapsed or refractory lymphoma [6] About MAR-T Cells - The MAR-T cell platform is a novel, non-genetically modified approach that selectively expands tumor-specific T cells capable of recognizing multiple tumor antigens [7] About Marker Therapeutics, Inc. - Marker Therapeutics is a clinical-stage immuno-oncology company focused on developing next-generation T cell-based immunotherapies for hematological malignancies and solid tumors [8]

Core Insights - Marker Therapeutics has initiated the Phase 1 RAPID study to evaluate the safety and efficacy of its Off-the-Shelf (OTS) multi-antigen recognizing (MAR) T cell product, MT-401, targeting four antigens in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) [1][2][8] - The first patient has been treated with the OTS product, showing promising preliminary safety data with no treatment-related adverse events reported [2][3] - The OTS program aims to expedite treatment by utilizing commercially available leukapheresis material, potentially allowing for treatment initiation within 72 hours and reducing manufacturing costs [3][4] 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 [9] - The company has a strong foundation in research and development, having conducted clinical trials with over 200 patients, demonstrating the tolerability and durable clinical responses of its MAR-T cell products [9] Funding and Support - The OTS program is supported by non-dilutive funding from the FDA, NIH Small Business Innovation Research (SBIR) program, and the Cancer Prevention and Research Institute of Texas (CPRIT), allowing the company to advance its clinical investigations without affecting its financial runway [3][8] Scientific Basis - The MAR-T cell platform is a novel, non-genetically modified cell therapy that selectively expands tumor-specific T cells capable of recognizing a broad range of tumor antigens, potentially reducing the risk of tumor escape [6][7] - The OTS product, MT-401-OTS, targets four tumor antigens (Survivin, PRAME, NY-ESO-1, WT-1) and is currently being investigated in a multicenter, open-label trial [8]

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]