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.

MARKER THERAPEUTICS CORPORATE PRESENTATION December 2024 NASDAQ: MRKR Forward Looking Statements Certain statements contained herein are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, that involve risks and uncertainties. All statements other than statements relating to historical matters including statements to the effect that we "believe", "expect", "anticipate", "plan", "target", " ...

Media and Investor Contact To join the virtual panel discussion, please contact your Canaccord Genuity conference representative. About Marker Therapeutics, Inc. Marker Therapeutics, Inc. is a Houston, TX-based clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors. The Company was founded at Baylor College of Medicine, and clinical trials that enrolled more than 200 patients acro ...

Exhibit 99.1 Marker Therapeutics Reports Year-End 2024 Corporate and Financial Results Lead program investigating MT-601 in patients with refractory lymphomas, including anti-CD19 CAR-T cell therapy, demonstrated safety and ef icacy in 9 patients with 78% having objective responses, including durable complete responses Secured over $13 million in non-dilutive funding from the Cancer Prevention & Research Institute of Texas (CPRIT) and the National Institute of Health (NIH) Small Business Innovation Research ...

Lead program investigating MT-601 in patients with refractory lymphomas, including anti-CD19 CAR-T cell therapy, demonstrated safety and efficacy in 9 patients with 78% having objective responses, including durable complete responses "In 2024, we made substantial progress advancing MT-601, our lead multi antigen recognizing (MAR)-T cell therapy, and laid the groundwork for continued momentum in 2025," said Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. "Preliminary data from ...

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].

Core Viewpoint - Marker Therapeutics, Inc. is actively participating in the H.C. Wainwright 3 Annual Cell Therapy Virtual Conference to present its advancements in T cell-based immunotherapies for treating hematological malignancies and solid tumors [1][2]. Company Overview - Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company based in Houston, TX, focusing on next-generation T cell-based immunotherapies [4]. - 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 [4]. - The company aims to introduce novel T cell therapies to the market while prioritizing financial resource preservation and operational excellence [4]. - Marker Therapeutics benefits from non-dilutive funding from U.S. state and federal agencies that support cancer research [4]. Event Details - Dr. Juan Vera, President and CEO of Marker Therapeutics, will present at the H.C. Wainwright 3 Annual Cell Therapy Virtual Conference on February 25, 2025, at 3:30 PM ET [2][3]. - The event will be held virtually, and registered participants can access the presentation through the event portal [3].

Core Viewpoint - Marker Therapeutics, Inc. has announced a private placement resulting in gross proceeds of $16.1 million to support the clinical advancement of its Phase 1 APOLLO study investigating MT-601 in patients with lymphoma who have relapsed after anti-CD19 CAR-T cell therapy or are ineligible for it [1][2]. Financing Details - The financing will support the collection of additional clinical data for Marker’s lead clinical asset in lymphoma, MT-601 [3]. - The company is selling 5,031,250 shares of common stock at a purchase price of $3.20 per share, along with accompanying warrants [4]. - The pre-funded warrants will be exercisable at a price of $0.001 per share, while the accompanying warrants will have an exercise price of $4.03 per share [5]. Clinical Study Information - MT-601 is a multi-antigen recognizing (MAR) T cell product targeting six different tumor antigens upregulated in lymphoma cells [8]. - The APOLLO trial is a Phase 1, multicenter, open-label study designed to evaluate the safety and efficacy of MT-601 in participants with relapsed or refractory lymphoma [9]. - The trial aims to enroll approximately 30 participants across nine clinical sites in the United States during the dose escalation phase [9]. Company Overview - Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company based in Houston, TX, focusing on developing next-generation T cell-based immunotherapies for hematological malignancies and solid tumors [12]. - The company’s unique T cell platform is supported by non-dilutive funding from U.S. state and federal agencies [12].

APOLLO study investigating MT-601 in patients with relapsed lymphoma: 78% of patients achieved objective response rates, with 44.4% demonstrating complete response (CR) MT-601 was observed to be well tolerated in all study participants with no observation of immune-effector cell associated neurotoxicity syndrome (ICANS) HOUSTON, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherap ...