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 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q DELAWARE 45-4497941 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 9350 Kirby Drive, Suite 300 Houston, Texas 77054 (Address of principal executive offices) (Zip Code) (713) 400-6400 (Issuer's telephone number) 4551 Kennedy Commerce Drive, Houston, Texas, 77032 ☒ Quarterly Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quart ...

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, 2023 ☐ 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. (Name of registrant in its charter) | DELAWARE | 45-4497941 | | --- | --- | | (State or oth ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q MARKER THERAPEUTICS, INC. (Name of registrant in its charter) DELAWARE 45-4497941 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 4551 Kennedy Commerce Drive Houston, Texas 77032 ☒ Quarterly Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended March 31, 2023 (Address of principal executive offices) (Zip Code) ...

Part I [Business](index=6&type=section&id=Item%201.%20Business) Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company developing non-engineered, multi-tumor associated antigen (multiTAA)-specific T cell therapies for hematological malignancies and solid tumors - The company's core technology is a **multiTAA-specific T cell platform** that manufactures non-engineered, tumor-specific T cells designed to recognize and kill cancer cells by targeting multiple tumor-associated antigens (TAAs)[19](index=19&type=chunk) - Key advantages of the multiTAA platform include targeting multiple antigens to minimize tumor escape, inducing a broader immune response, a **strong clinical safety profile** with no reported CRS, and a **less complex, lower-cost manufacturing process** compared to CAR-T therapies[22](index=22&type=chunk) Clinical Pipeline Overview | Product Candidate | Indication | Phase | Sponsor | |---|---|---|---| | MT-401 (zedenoleucel) | Post-Transplant AML (Adjuvant & Active Disease) | Phase 2 (ARTEMIS) | Company | | MT-401-OTS | AML/MDS | Phase 2 (IND Cleared) | Company | | MT-601 | Pancreatic Cancer (in combination with chemo) | Phase 1 (PANACEA) | Company | | MT-601 | Relapsed/Refractory Non-Hodgkin Lymphoma | Phase 1 (APOLLO) | Company | | multiTAA-T | Pancreatic Cancer | Phase 1/2 | BCM | | multiTAA-T | Lymphoma | Phase 1 | BCM | | multiTAA-T | Multiple Myeloma | Phase 1b/2a | BCM | | multiTAA-T | Acute Lymphoblastic Leukemia (ALL) | Phase 1 | BCM | | multiTAA-T | Breast Cancer | Phase 2 | BCM | - The company has developed an improved T cell manufacturing process that reduces production time from **over 30 days to 9 days**, yielding a product with **five times** the measurable specificity and **four times** the potency[32](index=32&type=chunk)[47](index=47&type=chunk) - The company operates its **own fully validated, FDA-registered cGMP manufacturing facility** in Houston, Texas, reducing reliance on contract manufacturing organizations (CMOs)[26](index=26&type=chunk)[103](index=103&type=chunk)[104](index=104&type=chunk) - The company holds a worldwide, exclusive license from Baylor College of Medicine (BCM) for the multiTAA-specific T cell technology, including up to **$64.85 million** in milestone payments and tiered royalties from **0.65% to 5.0%** on net sales[111](index=111&type=chunk)[112](index=112&type=chunk) [Risk Factors](index=51&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks related to its financial position, clinical development, and reliance on third parties - The company has a history of operating losses and expects them to continue, which raises **substantial doubt** about its ability to continue as a going concern, with cash reserves expected to fund operations only into the **third quarter of 2023**[183](index=183&type=chunk)[185](index=185&type=chunk)[186](index=186&type=chunk) - All product candidates are in clinical development, facing a **high risk of failure**, with no guarantee of successful trial completion, regulatory approval, or commercialization[190](index=190&type=chunk)[191](index=191&type=chunk) - The company's strategic relationship with Baylor College of Medicine (BCM) is **critical**, as the multiTAA-specific T cell therapy was developed through this collaboration, and most intellectual property is exclusively licensed from BCM[236](index=236&type=chunk)[237](index=237&type=chunk)[238](index=238&type=chunk) - Manufacturing of cell therapies is **complex and costly**, with risks related to scaling up production, equipment failures, and reliance on a **limited number of vendors** for specialized equipment and materials like the G-Rex® device[220](index=220&type=chunk)[225](index=225&type=chunk)[228](index=228&type=chunk) - The biotechnology industry is **highly competitive**, with Marker Therapeutics competing against larger, well-funded pharmaceutical and biotech companies that have **greater resources and experience** in development and commercialization[258](index=258&type=chunk)[259](index=259&type=chunk) - The business is subject to **extensive and costly government regulation** by the FDA and other authorities, with a lengthy and unpredictable regulatory approval process and no precedent for successful commercialization of multiTAA-specific T cell therapies[312](index=312&type=chunk)[313](index=313&type=chunk)[314](index=314&type=chunk) [Unresolved Staff Comments](index=113&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - None[375](index=375&type=chunk) [Properties](index=113&type=section&id=Item%202.%20Properties) Marker Therapeutics leases a manufacturing facility and principal business office in Houston, Texas, under a ten-year agreement expiring in November 2030, and a separate research facility under a 71-month lease - The company leases its principal business office and manufacturing facility in Houston, TX, with the lease set to expire in **November 2030**[376](index=376&type=chunk) - A separate research facility in Houston, TX is leased for a term of **71 months**, which commenced in **April 2020**[377](index=377&type=chunk) [Legal Proceedings](index=114&type=section&id=Item%203.%20Legal%20Proceedings) The company was involved in a FINRA arbitration proceeding regarding compensation for 2018 financing transactions, resulting in a total payment of $2.6 million - A FINRA arbitration panel awarded a broker **$2.4 million** for compensation, interest, and attorney fees related to 2018 financing transactions, with the company's motion to vacate the award denied[380](index=380&type=chunk) - The company paid the **$2.5 million** judgment (including interest) in March 2022 and an additional **$0.1 million** in post-judgment interest in January 2023, resolving the matter[380](index=380&type=chunk) [Mine Safety Disclosure](index=114&type=section&id=Item%204.%20Mine%20Safety%20Disclosure) This item is not applicable to the company - Not Applicable[381](index=381&type=chunk) Part II [Market For Registrant's Common Equity, Related Stockholder Matters And Issuer Purchases Of Equity Securities](index=115&type=section&id=Item%205.%20Market%20For%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20And%20Issuer%20Purchases%20Of%20Equity%20Securities) The company's common stock is traded on the Nasdaq Capital Market under "MRKR", and it has never paid cash dividends due to recurring losses - The company's common stock is listed on the **Nasdaq Capital Market** under the symbol "**MRKR**"[383](index=383&type=chunk) - **No dividends** have been declared or paid, and the company does not anticipate paying cash dividends in the foreseeable future[384](index=384&type=chunk) [Management's Discussion And Analysis Of Financial Condition And Results Of Operations](index=116&type=section&id=Item%207.%20Management%27s%20Discussion%20And%20Analysis%20Of%20Financial%20Condition%20And%20Results%20Of%20Operations) For FY2022, Marker Therapeutics reported $9.0 million in revenue, a net loss of $29.9 million, and a cash position of $11.8 million, raising substantial doubt about its going concern ability Results of Operations (2022 vs. 2021) | | For the Year Ended December 31, | Change | % Change | |---|---|---|---|---| | | 2022 | 2021 | ($) | (%) | | **Total revenues** | **$9,014,000** | **$1,242,000** | **$7,772,000** | **626%** | | Grant income | $3,514,000 | $1,242,000 | $2,272,000 | 183% | | Related party service revenue | $5,500,000 | $— | $5,500,000 | 100% | | **Total operating expenses** | **$38,959,000** | **$40,720,000** | **($1,761,000)** | **(4)%** | | Research and development | $26,139,000 | $27,795,000 | ($1,656,000) | (6)% | | General and administrative | $12,820,000 | $12,925,000 | ($105,000) | (1)% | | **Loss from operations** | **($29,946,000)** | **($39,478,000)** | **$9,532,000** | **(24)%** | | **Net loss** | **($29,931,000)** | **($41,879,000)** | **$11,948,000** | **(29)%** | | **Net loss per share** | **($3.58)** | **($5.47)** | **$1.89** | **(35)%** | - The company's cash, cash equivalents, and restricted cash decreased from **$43.5 million** at year-end 2021 to **$11.8 million** at year-end 2022[419](index=419&type=chunk) - Management states that existing cash will only fund operations into the **third quarter of 2023**, which raises **substantial doubt** about the company's ability to continue as a going concern[434](index=434&type=chunk)[442](index=442&type=chunk) - In December 2022, the company entered into a purchase agreement with Lincoln Park Capital Fund for the right to sell up to **$25.0 million** of its common stock over a **24-month period**[440](index=440&type=chunk) - A **one-for-ten reverse stock split** was effected on **January 26, 2023**, and all share and per-share data in the report have been retroactively adjusted[392](index=392&type=chunk)[393](index=393&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=136&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Marker Therapeutics is not required to provide the information for this item - The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide this information[464](index=464&type=chunk) [Financial Statements and Supplementary Data](index=136&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section contains the company's audited consolidated financial statements for FY2022 and FY2021, including the independent auditor's report and accompanying notes [Report of Independent Registered Public Accounting Firm](index=152&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The independent auditor issued an unqualified opinion on the financial statements, highlighting **substantial doubt** about the company's ability to continue as a **going concern** - The auditor's report contains an explanatory paragraph expressing **substantial doubt** about the Company's ability to continue as a **going concern**[515](index=515&type=chunk) - A critical audit matter identified was the determination of **impairment indicators** for **long-lived assets** and **right-of-use assets**, which involved significant management judgment[519](index=519&type=chunk)[521](index=521&type=chunk) [Consolidated Financial Statements](index=154&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements detail the company's financial position and performance, showing a decrease in total assets and a net loss for 2022 Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2022 | Dec 31, 2021 | |---|---|---| | Cash and cash equivalents | $11,782 | $42,351 | | Total Current Assets | $16,619 | $45,982 | | Total Assets | $34,422 | $68,135 | | Total Current Liabilities | $7,782 | $12,902 | | Total Liabilities | $14,821 | $24,150 | | Total Stockholders' Equity | $19,601 | $43,986 | Consolidated Cash Flow Data (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | |---|---|---| | Net cash used in operating activities | $(26,972) | $(27,280) | | Net cash used in investing activities | $(4,945) | $(3,131) | | Net cash provided by financing activities | $202 | $52,556 | | **Net (decrease) increase in cash** | **$(31,715)** | **$22,145** | [Notes to Consolidated Financial Statements](index=158&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes provide detailed information on the reverse stock split, going concern uncertainty, related party transactions, grant income, and net operating loss carryforwards - A **one-for-ten reverse stock split** was effected on **January 26, 2023**, with all share and per-share data retrospectively adjusted[535](index=535&type=chunk) - The company entered into a services agreement with Wilson Wolf, a related party, receiving an **$8.0 million** cash payment for training and research services, with **$5.5 million** recognized as revenue for 2022[542](index=542&type=chunk)[594](index=594&type=chunk)[599](index=599&type=chunk) - The company is recognizing revenue from a **$13.1 million** CPRIT grant and a **$2.0 million** FDA Orphan Products Grant to support its Phase 2 trial of MT-401[539](index=539&type=chunk)[543](index=543&type=chunk) - As of December 31, 2022, the company had approximately **$135.2 million** of federal and **$38.5 million** of state net operating loss (NOL) carryforwards, though their use may be limited under **Section 382**[634](index=634&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=136&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its principal independent accountants - The company had no changes in, or disagreements with, its principal independent accountants[466](index=466&type=chunk) [Controls and Procedures](index=137&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2022 - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2022[468](index=468&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2022[469](index=469&type=chunk) [Other Information](index=138&type=section&id=Item%209B.%20Other%20Information) The company reports no other information for this item - None[475](index=475&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=139&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information for this item is incorporated by reference from the company's 2023 Annual Meeting of Stockholders proxy statement - Information is incorporated by reference from the registrant's definitive proxy statement for the 2023 Annual Meeting of Stockholders[479](index=479&type=chunk) [Executive Compensation](index=139&type=section&id=Item%2011.%20Executive%20Compensation) Information for this item is incorporated by reference from the company's definitive proxy statement - Information is incorporated by reference from the registrant's definitive proxy statement[481](index=481&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=139&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information for this item is incorporated by reference from the company's definitive proxy statement - Information is incorporated by reference from the registrant's definitive proxy statement[482](index=482&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=139&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information for this item is incorporated by reference from the company's definitive proxy statement - Information is incorporated by reference from the registrant's definitive proxy statement[484](index=484&type=chunk) [Principal Accounting Fees and Services](index=139&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information for this item is incorporated by reference from the company's definitive proxy statement - Information is incorporated by reference from the registrant's definitive proxy statement[485](index=485&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=140&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the exhibits filed as part of the Form 10-K, including corporate governance documents, material contracts, and required certifications - This section contains the index of all exhibits filed with the Form 10-K[489](index=489&type=chunk) [Form 10-K Summary](index=148&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company did not provide a summary for this item - None[500](index=500&type=chunk)