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].

Core Insights - The APOLLO study demonstrates promising efficacy and safety for MT-601 in patients with relapsed lymphoma, with 78% of patients achieving objective response rates and 44.4% showing complete response [1][4][10] Safety - MT-601 infusion was well tolerated among all participants, with no cases of immune-effector cell associated neurotoxicity syndrome (ICANS) reported and only one instance of Grade 1 cytokine release syndrome (CRS) [3][11] - No dose limiting toxicities (DLTs) have been reported to date [3] Efficacy - In the first dose cohort, 7 out of 9 patients achieved objective responses (78%) at the first response assessment, with 4 patients demonstrating complete response (CR; 44.4%) [4][7] - Immunomonitoring data indicated that lymphodepletion enhanced the expansion and persistence of MAR-T cell clones in vivo [2] Follow-Up - Long-term follow-up data is available for three patients, with ongoing visits to assess the durability of responses [5][8] - The longest follow-up period recorded is 12 months for one patient, with two patients showing complete response (CR) and partial response (PR) at 6 months [8] Company Overview - Marker Therapeutics, Inc. is focused on developing next-generation T cell-based immunotherapies for hematological malignancies and solid tumors, with MT-601 being a multi-antigen recognizing (MAR) T cell product targeting six tumor antigens [13][16] - The APOLLO trial is a Phase 1, multicenter, open-label study evaluating the safety and efficacy of MT-601 in patients with relapsed or refractory lymphoma who have failed or are ineligible for anti-CD19 CAR-T cell therapy [14]

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].

Corporate Updates - Marker Therapeutics, Inc. is making significant progress in its Phase 1 APOLLO study of MT-601 for lymphoma patients who have relapsed after anti-CD19 CAR-T cell therapy or where CAR-T is not an option, with preliminary safety and efficacy data expected by the end of 2024 [2][3] - The company received two $2 million Small Business Innovation Research (SBIR) grants from the NIH to support the development of MT-601 in non-Hodgkin's lymphoma and pancreatic cancer [2][4] Program Updates - The Phase 1 APOLLO study is ongoing, with sustained objective responses observed in three participants, and no severe adverse effects reported [3] - The clinical investigation of MT-601 in metastatic pancreatic cancer is expected to start in 2025 [4] - Marker anticipates initiating the clinical program for MT-401-OTS in Acute Myeloid Leukemia or Myelodysplastic Syndrome in the first half of 2025 [5] Financial Highlights - As of September 30, 2024, Marker had cash and cash equivalents of $9 million, which is expected to fund operations into October 2025 [6] - Research and development expenses for Q3 2024 were $3.5 million, up from $2.0 million in Q3 2023, reflecting increased clinical trial activity [7] - General and administrative expenses decreased to $0.9 million in Q3 2024 from $1.4 million in Q3 2023 due to cost savings from a reorganization [7] - The net loss from continuing operations for Q3 2024 was $2.3 million, compared to $3.0 million in Q3 2023 [8] Revenue and Operating Expenses - Total revenues for Q3 2024 were $1.93 million, significantly higher than $0.26 million in Q3 2023, primarily due to increased grant income [15] - Total operating expenses for Q3 2024 were $4.33 million, compared to $3.46 million in Q3 2023 [15] T Cell Therapy Platform - Marker Therapeutics' multiTAA-specific T cell platform is a novel, non-genetically modified cell therapy that expands tumor-specific T cells capable of recognizing a broad range of tumor antigens, potentially offering improved safety and clinical benefits [9][10]

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]

Financial Performance - Total revenues for the three months ended June 30, 2024, were $1,169,000, representing a 53% increase from $763,000 in the same period of 2023[86]. - Total revenues for the six months ended June 30, 2024, were $2.4 million, a 21% increase from $2.0 million in the same period in 2023[93]. - Loss from operations improved by 44%, decreasing to $(2,308,000) in Q2 2024 from $(4,134,000) in Q2 2023[86]. - The net loss from continuing operations decreased by 45% to $4.6 million for the six months ended June 30, 2024, from $8.3 million in the same period in 2023[93]. Operating Expenses - Operating expenses decreased by 29% to $3,477,000 in Q2 2024 from $4,897,000 in Q2 2023, with general and administrative expenses dropping by 55%[86]. - Operating expenses for the three months ended June 30, 2024, were $3.5 million, a decrease from $4.9 million in the same period in 2023[89]. - Total operating expenses for the six months ended June 30, 2024, were $7.3 million, down 30% from $10.4 million in the same period in 2023[96]. - Operating expenses for the three and six months ended June 30, 2024 were $3.4 million and $7.2 million, respectively, compared to $4.9 million and $10.4 million in the prior year periods, indicating a decrease of approximately 30.6% and 30.6%[111]. Interest Income - Interest income increased significantly by 229% to $115,000 in Q2 2024 compared to $35,000 in Q2 2023[86]. - Interest income increased by 127% to $272,000 for the six months ended June 30, 2024, compared to $120,000 in the same period in 2023[93]. Grants and Revenue Recognition - The company recognized $0.7 million in revenue from the CPRIT grant for both Q2 2024 and Q2 2023, with additional revenue from FDA and NIH grants totaling $0.2 million and $0.2 million respectively in Q2 2024[87][88]. - The company has received a total of $13.1 million in grants from CPRIT to support the clinical investigation of MT-401, with $9.7 million received to date[107]. - The company recognizes revenue from grant income when qualifying costs are incurred, reflecting its critical accounting estimates[117]. Cash and Liquidity - Cash and cash equivalents as of June 30, 2024, were $7.8 million, down from $15.1 million as of December 31, 2023[101]. - As of June 30, 2024, the company had working capital of $9.7 million, down from $14.1 million as of December 31, 2023[111]. - The company expects its cash and cash equivalents will fund operations into the fourth quarter of 2025[100]. - The company expects its cash and cash equivalents as of June 30, 2024 to fund operating expenses and capital expenditures into Q4 2025, although this estimate is subject to change[111]. Organizational Changes - Organizational changes in 2023 included a reduction in headcount and the appointment of Dr. Juan Vera as President and CEO[82]. Product Development - The company is advancing two product candidates for clinical indications: MT-601 for lymphoma and pancreatic cancer, and MT-401-OTS for various indications[72]. Financing and Market Conditions - The company plans to fund operations and capital needs through equity and/or debt financing, which may dilute existing stockholders' ownership[113]. - High inflation and economic recession concerns have led to capital market volatility, potentially affecting the company's liquidity[114]. - The company may need additional funds sooner than planned to meet operational needs and capital requirements for product development and commercialization[111]. - The company is unable to estimate the actual amounts necessary for the development and commercialization of product candidates due to the early stages of clinical development[112]. Stock and Shareholder Matters - A reverse stock split of 1-for-10 was executed on January 26, 2023, reducing the total number of authorized shares from 300 million to 30 million[84]. - The company sold 8,178 shares under the ATM Agreement during the six months ended June 30, 2024, resulting in net proceeds of approximately $37,000 after agent commissions[115]. - The company has the right to sell up to $25 million of shares to Lincoln Park Capital Fund, LLC, but terminated this Purchase Agreement effective March 1, 2024[116].

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) ...