Marker Therapeutics (NasdaqCM:MRKR) FY Conference February 25, 2026 08:00 AM ET Company ParticipantsAnthony - AssociateJuan Vera - President and CEOAnthonyGood morning, everyone, and thanks so much for joining us. I'm Anthony, an associate here at Oppenheimer, and it is my pleasure to introduce Marker Therapeutics. Marker is an immuno-oncology company focused on developing T-cell therapies using its multi-antigen recognizing or MAR-T platform. The lead program is MT-601, and it's being studied in relapse ly ...

Core Viewpoint - CAR-T cell therapy has shown clinical success in hematological malignancies, but its efficacy in solid tumors remains significantly lower, highlighting the challenges faced by T cell therapies in this area [2][3]. Group 1: Challenges in T Cell Therapy for Solid Tumors - Three key obstacles for T cell therapy in solid tumors include: 1) antigen heterogeneity; 2) tumor microenvironment suppressing T cell function; 3) difficulty in cultivating sufficient non-exhausted T cells in vitro [3][5]. Group 2: Research Findings on ScTIL - A study published in Cell Reports Medicine introduced a "three-in-one" strategy to produce super circulating TIL-like cells (ScTIL) for the treatment of biliary tract cancer, demonstrating safety and significantly extending survival for late-stage patients [3][5][9]. - The ScTIL production involves: 1) isolating PD-1+ T cells from patient peripheral blood; 2) modifying these T cells with enhanced receptors to counteract tumor microenvironment suppression; 3) co-expressing amplification factors and anti-CD19 CAR for rapid in vivo expansion [5][8]. - In a clinical trial with 10 late-stage biliary tract cancer patients, ScTIL treatment resulted in a median overall survival (OS) of 18.3 months, surpassing the standard treatment OS of approximately 12 months [5][8]. Group 3: Implications for Future Treatments - The study indicates that ScTIL significantly improves survival rates for late-stage biliary tract cancer patients, suggesting it as a promising therapy for solid tumors and offering new hope for cell therapy in this domain [9].

Core Viewpoint - The research presents a breakthrough in T cell therapy by designing the world's first soluble Notch agonist, enabling efficient T cell differentiation in suspension culture and enhancing T cell function and anti-tumor immunity [3][7][8]. Group 1: Research Background - Notch signaling pathway is one of the most evolutionarily conserved pathways, crucial for the development and function of immune cells, particularly T cells [2][10]. - Traditional methods for T cell production rely on complex environments, making large-scale production challenging and costly [7][11]. Group 2: Research Breakthrough - The research team utilized AI protein design tools to create a soluble Notch agonist that activates the Notch signaling pathway in suspension culture, overcoming the mechanical activation challenge [3][8][12]. - The designed C3-DLL4 structure effectively bridges cells, facilitating the formation of immune synapses and activating Notch signaling [13][14]. Group 3: Applications and Advantages - The new method allows for the mass production of T cells in suspension bioreactors, significantly reducing production time and costs compared to traditional methods [16][19]. - In vivo experiments showed that C3-DLL4 enhances T cell function, indicating potential for developing Notch enhancers to improve cancer vaccines and infection prevention [18][19]. Group 4: Future Prospects - The research team is developing an upgraded version, C515H-DLL4, which further improves T cell differentiation efficiency, marking a step towards practical applications [22]. - The AI-designed proteins offer advantages in manufacturing, storage, and clinical administration, potentially transforming CAR-T cell production and vaccine development [23].

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.