Core Viewpoint - Marker Therapeutics, Inc. has received a $9.5 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT) to support the clinical investigation of its lead product MT-601 in patients with metastatic pancreatic cancer [1][5]. Group 1: Grant and Study Details - The CPRIT grant will support the Phase 1 PANACEA study, which evaluates the safety and tolerability of MT-601, a multi-tumor associated antigen-specific T cell product, in patients with metastatic pancreatic cancer [2]. - The company has received over $30 million in non-dilutive funding from various governmental institutions, including a recent $2 million grant from the NIH Small Business Innovation Research (SBIR) program [5][6]. Group 2: Product and Clinical Background - MT-601 is currently being studied for CD19-CAR relapsed lymphoma and has shown preliminary safety and efficacy with sustained objective responses in three participants [3]. - Previous studies have indicated that MT-601 can target multiple tumor-specific antigens, which may allow its application in solid tumors beyond lymphoma [4][9]. - A prior study at Baylor College of Medicine demonstrated favorable safety and durable cancer control in patients with pancreatic cancer treated with multiTAA-specific T cells [4]. Group 3: Company Overview - Marker Therapeutics is a clinical-stage immuno-oncology company focused on developing next-generation T cell-based immunotherapies for hematological malignancies and solid tumors [11]. - The company aims to introduce novel T cell therapies to the market while preserving financial resources and ensuring operational excellence [11].

Core Viewpoint - Marker Therapeutics, Inc. has received a $9.5 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT) to support the clinical investigation of its lead asset MT-601 in patients with metastatic pancreatic cancer [1][5]. Funding and Grants - The CPRIT grant will support the Phase 1 PANACEA study evaluating the safety and tolerability of MT-601 in patients with metastatic pancreatic cancer [2]. - Including the CPRIT grant, the company has secured over $30 million in non-dilutive funding from various governmental institutions, including a recent $2 million grant from the NIH Small Business Innovation Research (SBIR) program [5][6]. Clinical Trials and Research - MT-601 is currently being studied in patients with CD19-CAR relapsed lymphoma, with preliminary safety and efficacy data showing sustained objective responses in three participants [3]. - Previous studies at Baylor College of Medicine indicated that multiTAA-specific T cells, similar to MT-601, demonstrated a favorable safety profile and durable cancer control in pancreatic cancer patients [4]. Product Overview - MT-601 is a multi-tumor associated antigen (multiTAA)-specific T cell product that targets six different tumor antigens upregulated in cancer cells [7]. - The product utilizes a non-genetically modified approach, which may offer easier and less expensive manufacturing with an improved safety profile compared to current engineered T cell therapies [8]. Company Background - 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 [9]. - The company aims to introduce novel T cell therapies to the market while prioritizing financial resource preservation and operational excellence [9].

Financial Performance - Marker Therapeutics reported a net loss of $2.3 million for Q3 2024, an improvement from a net loss of $3.0 million in Q3 2023, representing a 23.3% reduction in losses year-over-year[10]. - The company reported a loss from continuing operations of $2.31 million for Q3 2024, compared to a loss of $2.98 million in Q3 2023, indicating a 22.4% improvement[16]. - Net loss from continuing operations for the nine months ended September 30, 2024, was $6,893,691, compared to a loss of $11,305,768 for the same period in 2023[18]. - Total net cash used in operating activities decreased to $6,207,189 for the nine months ended September 30, 2024, from $14,072,377 in 2023[18]. - The company reported a net decrease in cash and cash equivalents of $6,111,786 for the nine months ended September 30, 2024[18]. Revenue and Grants - Total revenues for Q3 2024 were $1.93 million, significantly higher than $257,606 reported in Q3 2023, marking a 650.5% increase[16]. - The company received two $2 million grants from the NIH Small Business Innovation Research (SBIR) program to support the clinical investigation of MT-601 in lymphoma and pancreatic cancer[2]. Research and Development - Research and development expenses increased to $3.5 million in Q3 2024, up from $2.0 million in Q3 2023, reflecting heightened clinical trial activity[9]. - The Phase 1 APOLLO study of MT-601 in lymphoma patients is ongoing, with preliminary safety and efficacy data expected by the end of 2024[2]. - The company anticipates starting the clinical program for MT-601 in metastatic pancreatic cancer in 2025[7]. Cash and Assets - As of September 30, 2024, Marker Therapeutics had cash and cash equivalents of $9 million, which is expected to fund operations into October 2025[8]. - Cash and cash equivalents at the end of the period were $8,999,664, down from $17,473,899 at the end of the same period in 2023[18]. - Marker Therapeutics' total assets decreased to $10.91 million as of September 30, 2024, down from $17.13 million at the end of 2023[15]. Expenses and Cost Management - General and administrative expenses decreased to $0.9 million in Q3 2024 from $1.4 million in Q3 2023, reflecting cost savings from a reorganization[9]. - Stock-based compensation for the nine months ended September 30, 2024, was $195,320, a decrease from $714,899 in 2023[18]. - Net cash provided by financing activities totaled $95,403, significantly lower than $1,099,982 in the same period last year[18]. - Proceeds from the issuance of common stock, net, amounted to $36,902, compared to $1,014,640 in the previous year[18]. Changes in Financial Position - Changes in accounts payable and accrued expenses resulted in an increase of $812,142 for the nine months ended September 30, 2024[18]. - Other receivables showed a significant decrease, with a net change of $283,405 compared to $2,318,691 in the previous year[18]. - Cash flows from discontinued operations showed no net cash provided by investing activities for the current period, compared to $18,664,122 in 2023[18].

HOUSTON, Nov. 14, 2024 (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 reported corporate updates and financial results for the third quarter ended September 30, 2024. “As we approach the end of 2024, we continue to build momentum across our clinical and corporate programs,” said Juan Vera, M.D., President and Chief ...

Revenue Generation - The company did not generate any revenue during the three months ended September 30, 2024 and 2023 from the sales or licensing of its product candidates [110]. - The company recognized $0.9 million and $0.2 million of revenue during the three months ended September 30, 2024 and 2023, respectively, associated with a $13.1 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) [111]. - The company recognized $0.02 million of revenue during the three months ended September 30, 2024 and 2023, respectively, associated with a $2.0 million grant from the FDA's Orphan Products Grant program [112]. - The company recognized $0.3 million of revenue during the three months ended September 30, 2024, associated with a $2.0 million grant from the National Institutes of Health SBIR program, while no revenue was recognized in the same period of 2023 [113]. - Grant income for the three months ended September 30, 2024, was $1,926,000, a 647% increase from $258,000 in the same period of 2023 [114]. - Total revenues for the three months ended September 30, 2024, were $1,926,000, reflecting a 647% increase compared to $258,000 in the prior year [114]. - Grant income for the nine months ended September 30, 2024, was $4,339,000, a 92% increase from $2,255,000 in the same period of 2023 [130]. - The company recorded $0.9 million and $2.4 million of grant income related to the CPRIT grant as revenue during the three and nine months ended September 30, 2024, respectively [146]. Expenses and Losses - The company incurred $1.2 million and $3.1 million in expenses related to services and manufacturing costs for the three and nine months ended September 30, 2024, respectively [101]. - Research and development expenses increased by 70% to $3,471,000 for the three months ended September 30, 2024, up from $2,045,000 in the same period of 2023 [117]. - General and administrative expenses decreased by 39% to $855,000 for the three months ended September 30, 2024, compared to $1,413,000 in the same period of 2023 [119]. - Total operating expenses for the three months ended September 30, 2024, were $4,326,000, a 25% increase from $3,458,000 in the same period of 2023 [114]. - Loss from operations for the three months ended September 30, 2024, was $(2,400,000), a 25% improvement from $(3,200,000) in the same period of 2023 [114]. - Total operating expenses for the nine months ended September 30, 2024, were $11,597,000, a 17% decrease from $13,898,000 in the same period of 2023 [130]. - Net loss from continuing operations for the nine months ended September 30, 2024, was $(6,895,000), a 39% improvement from $(11,305,000) in the same period of 2023 [130]. - Operating expenses for the three and nine months ended September 30, 2024, were $4.3 million and $11.6 million, respectively, compared to $3.5 million and $13.9 million in the prior year periods [152]. Grants and Funding - The company received a $2.0 million grant from the National Institutes of Health SBIR Program in August 2024 to support the advancement of MT-601 in patients with pancreatic cancer [107]. - The company received notice of a $2.0 million grant from the National Institutes of Health SBIR Program to support the clinical investigation of MT-601 in patients with non-Hodgkin's lymphoma who have relapsed following anti-CD19 CAR T cell therapy [108]. - The company received a $2.0 million grant from the FDA's Orphan Products Grant program for the clinical investigation of MT-401, with $1.0 million received to date [147]. - The company has received a total of approximately $13.1 million from the CPRIT grant, with $9.7 million received to date [146]. Financial Position - Cash and cash equivalents as of September 30, 2024, were $9,000,000, down from $15,111,000 as of December 31, 2023 [137]. - As of September 30, 2024, the company had working capital of $7.4 million, down from $14.1 million as of December 31, 2023 [152]. - The company anticipates needing substantial additional funding for ongoing operations and may need to raise capital sooner than planned [152]. - The company has entered into an ATM Agreement allowing for the sale of up to $75.0 million in common stock, with net proceeds of approximately $37,000 from sales during the nine months ended September 30, 2024 [156]. Organizational Changes - The company implemented organizational changes in 2023, including a reduction in headcount and the appointment of Dr. Juan Vera as President and CEO [103]. - The company executed a one-for-ten reverse stock split on January 26, 2023, reducing the total number of authorized shares from 300 million to 30 million [106]. Market Conditions - High inflation and economic recession concerns have resulted in capital market volatility, potentially affecting the company's liquidity [155]. - The company plans to continue funding operations through equity and/or debt financing, which may dilute existing stockholders' interests [154].

Financial Performance - Marker Therapeutics reported a net loss of $2.2 million for Q2 2024, a decrease from $4.1 million in Q2 2023, reflecting improved financial performance[7] - Total revenues for June 2024 were $1,169,236, an increase of 53.3% compared to $762,658 in June 2023[14] - Loss from operations improved to $(2,308,065) in June 2024 compared to $(4,134,060) in June 2023, a decrease of 44.2%[14] - Net loss from continuing operations for June 2024 was $(4,585,499), down from $(8,323,807) in June 2023, reflecting a 44.0% improvement[16] Expenses - Research and development expenses for Q2 2024 were $2.3 million, slightly down from $2.4 million in the same quarter last year[7] - General and administrative expenses decreased significantly to $1.1 million in Q2 2024 from $2.5 million in Q2 2023[7] - Total operating expenses decreased to $3,477,301 in June 2024 from $4,896,718 in June 2023, representing a reduction of 29.0%[14] - Research and development expenses were $2,335,430 in June 2024, slightly down from $2,377,993 in June 2023[14] - General and administrative expenses significantly decreased to $1,141,871 in June 2024 from $2,518,725 in June 2023, a reduction of 54.7%[14] Cash Position - The company had cash and cash equivalents of $7.8 million as of June 30, 2024, which is expected to fund operations into Q4 2025[7] - Cash and cash equivalents at the end of June 2024 were $7,800,464, a decrease from $18,122,086 at the end of June 2023[16] - Net cash used in operating activities for June 2024 was $(7,404,688), compared to $(12,944,918) in June 2023, indicating a 42.0% reduction[16] Clinical Trials and Research - The Phase 1 APOLLO study of MT-601 showed that all three participants had objective responses, with no significant treatment-related adverse events reported[2] - Marker Therapeutics received a $2 million grant from the NIH to support the clinical investigation of MT-601 in patients with lymphoma[4] - The FDA cleared the IND application for MT-601 to be investigated in combination with front-line chemotherapy for metastatic pancreatic cancer[5] - The company is enrolling additional participants in the Phase 1 APOLLO trial and expects to provide updates on safety and durability in Q3 2024[4] - Marker Therapeutics has established a cellular inventory for MT-401-OTS, which is intended for patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome[5] Stockholders' Equity - Total stockholders' equity decreased to $9.7 million as of June 30, 2024, down from $14.1 million at the end of 2023[13] Other Financial Metrics - Interest income increased to $115,388 in June 2024 from $35,080 in June 2023, marking a growth of 228.3%[14] - The weighted average number of common shares outstanding was 8,918,233 in June 2024, compared to 8,798,956 in June 2023, an increase of 1.4%[14]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ Quarterly Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended June 30, 2024 ☐ Transition Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from _____ to _____. Commission File Number: 001-37939 MARKER THERAPEUTICS, INC. | --- | --- | |----------------------------------------------------------------|----------- ...

Preliminary safety and efficacy with sustained objective responses observed in patients with lymphoma treated with MT-601 in Phase 1 APOLLO study MT-601 was well tolerated with no observation of cytokine release syndrome (CRS) or immune effector cell associated neurotoxicity syndrome (ICANS) Marker Therapeutics to receive $2 million funding from NIH Small Business Innovation Research (SBIR) program to support clinical investigation of MT-601 in patients with lymphoma HOUSTON, Aug. 14, 2024 (GLOBE NEWSWIRE) ...

Exhibit 99.1 Marker Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Updates Preliminary safety and ef icacy with sustained objective responses observed in patients with lymphoma treated with MT-601 in Phase 1 APOLLO study Study participant with Non-Hodgkin's Lymphoma who relapsed within 90 days of anti-CD19 CAR T cell therapy remains in complete response nine months after MT-601 treatment Company received approval from United States Adopted Name (USAN) council and Internation ...

MT-601 (Lymphoma) Phase 1 multicenter APOLLO trial (clinicaltrials.gov identifier: NCT05798897), investigating MT-601 in patients with lymphoma who relapsed or are ineligible for anti-CD19 CAR T cell therapies, was selected as lead program based on promising preliminary clinical results and non-clinical proof-of-concept data (Press Release, January 8, 2024). Three patients were treated at City of Hope National Medical Center as part of the APOLLO study: First study participant treated with MT-601 had diffus ...