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].

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 - 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) ...

[First Quarter 2024 Business and Clinical Update](index=1&type=section&id=First%20Quarter%202024%20Business%20and%20Clinical%20Update) Marker Therapeutics provides an overview of its Q1 2024 business and clinical advancements, highlighting promising MT-601 lymphoma data and program milestones [First Quarter 2024 Highlights](index=1&type=section&id=First%20Quarter%202024%20Highlights) Marker Therapeutics reported promising preliminary Phase 1 APOLLO study data for MT-601 in lymphoma, showing sustained objective responses and securing the nonproprietary name "neldaleucel" - Preliminary safety and efficacy with **sustained objective responses** were observed in lymphoma patients treated with MT-601 in the Phase 1 APOLLO study[1](index=1&type=chunk) - A study participant with Non-Hodgkin's Lymphoma, who had relapsed within 90 days of anti-CD19 CAR T cell therapy, remains in **complete response nine months** after receiving MT-601 treatment[1](index=1&type=chunk)[2](index=2&type=chunk) - MT-601 received the approved nonproprietary name "**neldaleucel**" from the United States Adopted Name (USAN) council and the International Nonproprietary Names (INN) expert committee[1](index=1&type=chunk)[2](index=2&type=chunk) [Program Updates & Expected Milestones](index=2&type=section&id=PROGRAM%20UPDATES%20%26%20EXPECTED%20MILESTONES) The company is prioritizing the MT-601 lymphoma program, while the pancreatic cancer program awaits funding and the AML program shifts to an "Off-the-Shelf" approach [MT-601 (Lymphoma)](index=2&type=section&id=MT-601%20(Lymphoma)) The MT-601 lymphoma program, selected as the lead, shows objective responses in all three initial patients with plans for further enrollment and data reporting - The Phase 1 multicenter APOLLO trial for MT-601 was selected as the **lead program** for patients with lymphoma who relapsed or are ineligible for anti-CD19 CAR T cell therapies[3](index=3&type=chunk) - **All three patients** treated at City of Hope demonstrated **objective responses** (two complete, one partial) and the treatment was well-tolerated with no significant treatment-related adverse events like cytokine release syndrome or neurotoxicity[5](index=5&type=chunk) - The company plans to enroll additional patients in the APOLLO trial and report further data in the **second half of 2024**[5](index=5&type=chunk) [MT-601 (Pancreatic)](index=2&type=section&id=MT-601%20(Pancreatic)) The MT-601 pancreatic cancer program has FDA IND clearance, with clinical advancement contingent on securing additional non-dilutive funding - The FDA has cleared the Investigational New Drug (**IND**) application for a Phase 1 trial of MT-601 in patients with metastatic pancreatic cancer[5](index=5&type=chunk) - Clinical advancement for the pancreatic cancer program is **contingent upon securing additional financial support** through non-dilutive grant activities[5](index=5&type=chunk) [MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic Syndrome)](index=2&type=section&id=MT-401-OTS%20(Acute%20Myeloid%20Leukemia%20or%20Myelodysplastic%20Syndrome)) The AML program has shifted to an "Off-the-Shelf" MT-401-OTS product, which has received IND and Orphan Drug Designations, with clinical trials expected in H2 2024 - The company has shifted its AML program to focus on an "**Off-the-Shelf**" (**OTS**) **product, MT-401-OTS**, discontinuing the patient-specific approach to streamline resources[4](index=4&type=chunk) - MT-401-OTS has been granted an **IND** by the U.S. FDA and received **Orphan Drug Designation** from both the EMA and FDA[10](index=10&type=chunk) - Clinical program initiation for MT-401-OTS is anticipated in the **second half of 2024**, supported by **$2 million** in non-dilutive funding from an NIH SBIR grant[10](index=10&type=chunk) [First Quarter 2024 Financial Results](index=3&type=section&id=First%20Quarter%202024%20Financial%20Results) Marker Therapeutics reports its Q1 2024 financial performance, detailing cash position, reduced operating expenses, and a significantly lower net loss [Financial Highlights Summary](index=3&type=section&id=FIRST%20QUARTER%202024%20FINANCIAL%20HIGHLIGHTS) Marker Therapeutics held **$11.3 million** in cash as of March 31, 2024, projecting funding into Q4 2025, with reduced R&D and G&A expenses leading to a lower **$2.4 million** net loss - Cash and cash equivalents stood at **$11.3 million** as of March 31, 2024, which is expected to fund operating expenses into the **fourth quarter of 2025**[6](index=6&type=chunk) Q1 2024 vs. Q1 2023 Financial Comparison | Financial Metric | Q1 2024 ($) | Q1 2023 ($) | | :--- | :--- | :--- | | R&D Expenses | $2.6 million | $3.4 million | | G&A Expenses | $1.2 million | $2.2 million | | Net Loss | $2.4 million | $4.9 million | [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2024, total assets were **$14.1 million**, a decrease from **$17.1 million** at year-end 2023, with total liabilities at **$2.3 million** and stockholders' equity at **$11.8 million** Balance Sheet Summary (Unaudited) | Balance Sheet Item | March 31, 2024 ($) | December 31, 2023 ($) | | :--- | :--- | :--- | | Cash and cash equivalents | $11,323,428 | $15,111,450 | | Total Assets | $14,091,899 | $17,127,391 | | Total Liabilities | $2,303,665 | $3,074,848 | | Total Stockholders' Equity | $11,788,234 | $14,052,543 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) In Q1 2024, Marker Therapeutics reported **$1.24 million** in grant income and significantly reduced operating expenses to **$3.8 million**, resulting in a net loss of **$2.4 million**, or **($0.27)** per share Statement of Operations Summary (Unaudited, For the Three Months Ended March 31) | Income Statement Item | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Grant income | $1,244,061 | $1,234,336 | | Total operating expenses | $3,793,078 | $5,543,815 | | Loss from operations | ($2,549,017) | ($4,309,479) | | **Net loss** | **($2,392,822)** | **($4,967,576)** | | **Net loss per share, basic and diluted** | **($0.27)** | **($0.57)** | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) In Q1 2024, the company utilized **$3.8 million** in cash for operating activities, resulting in a **$3.8 million** decrease in cash and equivalents, ending the period at **$11.3 million** Statement of Cash Flows Summary (Unaudited, For the Three Months Ended March 31) | Cash Flow Item | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | ($3,837,118) | ($5,888,295) | | Net cash provided by financing activities | $49,096 | $619,974 | | Net decrease in cash and cash equivalents | ($3,788,022) | ($5,380,929) | | **Cash and cash equivalents at end of period** | **$11,323,428** | **$6,401,243** | [About Marker Therapeutics](index=3&type=section&id=About%20Marker%20Therapeutics) Marker Therapeutics is a clinical-stage immuno-oncology company leveraging its multiTAA-specific T cell platform for cancer therapies, emphasizing financial discipline and non-dilutive funding [About multiTAA-specific T cells](index=3&type=section&id=About%20multiTAA-specific%20T%20cells) Marker Therapeutics' core multiTAA-specific T cell platform is a non-genetically modified cell therapy designed to recognize a broad range of tumor antigens, offering potential advantages over engineered CAR-T and TCR therapies - The **multiTAA-specific T cell platform** is a novel, **non-genetically modified cell therapy** approach that expands tumor-specific T cells capable of recognizing a broad range of tumor antigens[8](index=8&type=chunk) - Marker believes its product candidates will be **easier and less expensive to manufacture**, with **reduced toxicities**, compared to current engineered CAR-T and TCR-based approaches[8](index=8&type=chunk) [Company Overview](index=3&type=section&id=Company%20Overview) Marker Therapeutics is a Houston-based clinical-stage immuno-oncology company developing T cell immunotherapies for cancers, prioritizing financial discipline and leveraging non-dilutive government funding - Marker Therapeutics is a **clinical-stage immuno-oncology company** focused on developing **T cell-based immunotherapies** for hematological malignancies and solid tumors[9](index=9&type=chunk) - The company prioritizes the preservation of financial resources and operational excellence, and its platform is supported by **non-dilutive funding** from U.S. state and federal agencies[9](index=9&type=chunk)

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 ...

[PART I – FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Marker Therapeutics reported a net loss of **$2.4 million** for Q1 2024, a significant reduction from **$5.0 million** in Q1 2023, driven by lower operating expenses [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$14.1 million** as of March 31, 2024, from **$17.1 million** at year-end 2023, primarily due to reduced cash and cash equivalents Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $11,323 | $15,111 | | Total current assets | $14,092 | $17,127 | | **Total assets** | **$14,092** | **$17,127** | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $2,304 | $3,075 | | **Total liabilities** | **$2,304** | **$3,075** | | **Total stockholders' equity** | **$11,788** | **$14,053** | | **Total liabilities and stockholders' equity** | **$14,092** | **$17,127** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss significantly decreased to **$2.4 million** in Q1 2024 from **$5.0 million** in Q1 2023, driven by reduced R&D and G&A expenses Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Grant income | $1,244 | $1,234 | | **Total revenues** | **$1,244** | **$1,234** | | Research and development | $2,575 | $3,376 | | General and administrative | $1,218 | $2,167 | | **Total operating expenses** | **$3,793** | **$5,544** | | Loss from operations | ($2,549) | ($4,309) | | Loss from continuing operations | ($2,393) | ($4,225) | | Loss from discontinued operations | $0 | ($743) | | **Net loss** | **($2,393)** | **($4,968)** | | **Net loss per share** | **($0.27)** | **($0.57)** | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$3.8 million** in Q1 2024, leading to a net decrease in cash and cash equivalents to **$11.3 million** Condensed Consolidated Statements of Cash Flows (in thousands) | | For the Three Months Ended March 31, 2024 | For the Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($3,837) | ($5,888) | | Net cash used in investing activities | $0 | ($113) | | Net cash provided by financing activities | $49 | $620 | | **Net decrease in cash and cash equivalents** | **($3,788)** | **($5,381)** | | Cash and cash equivalents at beginning of period | $15,111 | $11,782 | | **Cash and cash equivalents at end of period** | **$11,323** | **$6,401** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's immuno-oncology focus, the strategic shift from its 2023 asset sale, reliance on grant funding, and projected cash runway into Q4 2025 - The company is a clinical-stage immuno-oncology company focused on developing multiTAA-specific T cell immunotherapies[14](index=14&type=chunk) - In June 2023, the company sold its manufacturing facilities and related assets to Cell Ready, LLC for **$19.0 million**, treated as a discontinued operation and a significant strategic shift[15](index=15&type=chunk)[16](index=16&type=chunk) - The company effected a **1-for-10 reverse stock split** on January 26, 2023, reducing authorized common stock from **300 million** to **30 million** shares[21](index=21&type=chunk) - Based on current plans, the company expects its cash and cash equivalents of **$11.3 million** as of March 31, 2024, will fund operations into the **fourth quarter of 2025**[30](index=30&type=chunk) - In Q1 2024, the company incurred **$1.2 million** in expenses for services from Cell Ready, a related party, for GMP drug product manufacturing[72](index=72&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management attributes improved Q1 2024 financial results to significant cost reductions post-asset sale, focusing on advancing its clinical pipeline with outsourced manufacturing, while relying on external financing for future operations [Company Overview and Pipeline](index=24&type=section&id=Company%20Overview%20and%20Pipeline) Marker Therapeutics is a clinical-stage immuno-oncology company developing multiTAA-specific T cell therapies, with a pipeline including MT-601 and MT-401-OTS, offering advantages over CAR-T - The company specializes in multiTAA-specific T cell technology, which expands a patient's own tumor-specific T cells to recognize and kill cancer cells[78](index=78&type=chunk) - Key advantages cited over CAR-T therapies include targeting multiple tumor antigens, a strong clinical safety profile with no observed CRS, and a non-genetically engineered process reducing manufacturing complexity and cost[80](index=80&type=chunk)[81](index=81&type=chunk) - The clinical pipeline features **MT-601** (autologous) for lymphoma and pancreatic cancer, and **MT-401-OTS** (off-the-shelf) for various indications[80](index=80&type=chunk)[84](index=84&type=chunk) - Recent data from the APOLLO study of **MT-601** presented in April 2024 showed that participants tolerated the initial dose level well and demonstrated durable objective responses[83](index=83&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Loss from continuing operations decreased **43%** to **$2.4 million** in Q1 2024, driven by a **32%** reduction in total operating expenses, including R&D and G&A Comparison of Operations for the Three Months Ended March 31 (in thousands) | | 2024 | 2023 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Grant income | $1,244 | $1,234 | $10 | 1% | | Research and development | $2,575 | $3,376 | ($801) | (24)% | | General and administrative | $1,218 | $2,167 | ($949) | (44)% | | **Loss from continuing operations** | **($2,393)** | **($4,224)** | **$1,831** | **(43)%** | - The **$0.8 million** decrease in R&D expenses was mainly due to lower process development, clinical trial, and headcount costs, partially offset by a **$1.2 million** increase in outsourced clinical manufacturing costs with Cell Ready[107](index=107&type=chunk)[108](index=108&type=chunk) - The **$1.0 million** decrease in G&A expenses was primarily driven by reduced headcount-related costs (**$0.4 million**) and lower legal and professional fees (**$0.4 million**)[108](index=108&type=chunk)[109](index=109&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) The company's cash and cash equivalents decreased to **$11.3 million** by March 31, 2024, with current funds projected to last into Q4 2025, necessitating continued reliance on external financing Cash and Working Capital (in thousands) | | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $11,323 | $15,111 | | Working capital | $11,788 | $14,053 | - Net cash used in operating activities from continuing operations was **$3.8 million** for Q1 2024[113](index=113&type=chunk)[114](index=114&type=chunk) - The company expects its cash on hand as of March 31, 2024, will fund operating expenses and capital requirements into the **fourth quarter of 2025**[124](index=124&type=chunk) - The company has access to capital through an ATM agreement, though its use is limited, selling **8,178 shares** for net proceeds of **$0.04 million** in April 2024[128](index=128&type=chunk)[73](index=73&type=chunk) - The company terminated its **$25 million** stock purchase agreement with Lincoln Park Capital on February 29, 2024[129](index=129&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, Marker Therapeutics is exempt from providing quantitative and qualitative disclosures about market risk - The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information under this item[131](index=131&type=chunk) [Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded that disclosure controls and procedures were effective as of March 31, 2024, with no material changes to internal control over financial reporting during the quarter - Management evaluated disclosure controls and procedures and concluded they were effective as of the end of the period covered by the report[132](index=132&type=chunk) - There were no changes in internal control over financial reporting during the fiscal quarter ended March 31, 2024, that materially affected, or are reasonably likely to materially affect, internal controls[135](index=135&type=chunk) [PART II – OTHER INFORMATION](index=38&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings.) The company is not currently a party to any material legal proceedings, nor is it aware of any pending or threatened litigation - The company is not currently a party to any material legal proceedings[136](index=136&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.Risk%20Factors.) No material changes to the risk factors previously disclosed in the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 - There have been no material changes to the risk factors described in the Annual Report on Form 10-K for the fiscal year ended December 31, 2023[137](index=137&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=38&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) The company recorded no unregistered sales of equity securities during the three months ended March 31, 2024 - No issuances of unregistered securities were recorded during the three months ended March 31, 2024[138](index=138&type=chunk) [Exhibits](index=39&type=section&id=Item%206.%20Exhibits.) This section lists exhibits filed with the Form 10-Q, including CEO and CFO certifications and interactive data files - The report includes CEO and CFO certifications pursuant to Rule 13a-14(a) and Section 906 of the Sarbanes-Oxley Act of 2002[142](index=142&type=chunk) - The Master Services Agreement with Cell Ready LLC is incorporated by reference[142](index=142&type=chunk)

Exhibit 99.1 Marker Therapeutics Reports Year-End 2023 Corporate and Financial Results Lead program in patients with lymphoma demonstrated preliminary safety and efficacy results with sustained complete response in first study participant treated with MT-601 (Neldaleucel) following CAR T relapse Secured non-dilutive funding of $2 million from National Institute of Health (NIH) to support clinical program for treatment of patients with Acute Myeloid Leukemia (AML) Received Orphan Drug Designation (ODD) from ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO 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. (Exact name of registrant as specified in its charter) Delawa ...