Marker Therapeutics, Inc.

Company Overview

Business Model: Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company focused on developing novel T cell-based immunotherapies for hematological malignancies and solid tumor indications. The Company's core technology is Multi Antigen Recognizing (“MAR”)-T cells, designed to recognize and kill highly heterogeneous tumors without genetic modifications. This approach selectively expands natural tumor-specific T cells from a patient’s or donor’s blood that can recognize a broad range of tumor associated antigens (TAAs), targeting hundreds of different epitopes within up to six tumor-specific antigens simultaneously to limit tumor adaptation and escape. The Company licensed this technology from Baylor College of Medicine in March 2018. Current product candidates include an autologous MAR-T cell product (MT-601) and an Off-the-Shelf (“OTS”) product (MT-401-OTS). The Company believes its non-genetically engineered approach offers advantages over CAR-T therapies, including enhanced tumoricidal effects, clinical safety (no treatment-related side effects like cytokine release syndrome or neurotoxicity observed), and reduced manufacturing complexity and cost.

Market Position: Marker Therapeutics, Inc. is a clinical-stage company with no approved products. It aims to address significant unmet medical needs, particularly in relapsed lymphoma patients who have failed or are ineligible for anti-CD19 CAR-T cell therapy, a population with a 40-60% relapse rate. MT-601 is positioned as the only natural T cell product targeting multiple tumor antigens for this specific patient group. The Company operates in a highly competitive biotechnology and immunotherapy industry, competing with numerous pharmaceutical and biotechnology companies, academic institutions, and government agencies that possess greater financial, technical, and human resources. Key competitors in lymphoma treatment include approved CD19-directed CAR-T cell therapies (Yescarta, Kymriah, Tecartus, Bryanzi), as well as other non-CD19 targeting CAR-T cells, multi-targeted CAR-T cells, NK-CAR therapies, and bispecific antibodies.

Recent Strategic Developments:

• MT-601 for Lymphoma (APOLLO Study): The Phase 1 multicenter, open-label study for relapsed lymphoma patients (who failed or are ineligible for anti-CD19 CAR-T) was initiated in January 2023. An August 2025 update (data cutoff June 2025) reported clinical data from 24 B cell lymphoma patients (15 Non-Hodgkin Lymphoma, 9 Hodgkin Lymphoma), showing objective responses and a favorable safety profile (no ICANS observed). The study has advanced to the dose expansion phase for Diffuse Large B Cell Lymphoma patients.
• MT-601 for Pancreatic Cancer (PANACEA Study): Received FDA orphan drug designation in January 2022. An IND was cleared in November 2022 for a Phase 1 multicenter clinical trial to assess MT-601 in combination with front-line chemotherapy for locally advanced, unresectable or metastatic pancreatic cancer. This program is supported by a $9.5 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT) and a $2 million grant from the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program, both awarded in 2024. Prior Phase 1/2 data from Baylor College of Medicine showed encouraging objective clinical responses and an 84.6% disease control rate, with no cytokine release syndrome or neurotoxicity.
• MT-401-OTS Program (RAPID Study): Since January 2024, Marker Therapeutics, Inc. has been advancing MT-401 as an Off-the-Shelf product for Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS). This program aims to provide a fast treatment option (as fast as 72 hours) using commercially available leukapheresis material from healthy donors, with a single donor potentially treating approximately 40 patients. In October 2025, the first patient was treated, showing encouraging preliminary safety data. This program is supported by grants from the FDA Orphan Products Grant program, NIH SBIR program, and CPRIT.
• Manufacturing Partnerships: The Master Services Agreement with Cell Ready was mutually terminated on March 27, 2025, with a settlement payment of $453,000. On June 16, 2025, the Company entered into a Statement of Work with Cellipont Bioservices, a Contract Development and Manufacturing Organization (CDMO), for cGMP manufacturing of MT-601 to support the APOLLO study and future commercial scale production. Baylor College of Medicine continues to supply products for ongoing clinical trials.
• Capital Raising: In July and August 2025, the Company sold 5,358,292 shares of common stock through an At The Market (ATM) Agreement with H.C. Wainwright & Co. LLC, generating net proceeds of $9.9 million. A private placement in December 2024 raised approximately $14.9 million in net proceeds from the sale of common stock, pre-funded warrants, and private placement warrants.

Geographic Footprint: Marker Therapeutics, Inc.'s principal executive offices are in Houston, Texas. Clinical trials, such as the APOLLO study, are conducted across multiple sites in the United States. The Company holds a worldwide exclusive license for its core technology and has received orphan drug designation for MT-401 in AML from the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA), indicating international strategic interest.

Financial Performance

Revenue Analysis

Profitability Metrics:

• Gross Margin: N/A (No product sales revenue)
• Operating Margin: -363.5%
• Net Margin: -343.0%

Investment in Growth:

• R&D Expenditure: $11,799,154 (332.7% of revenue)
• Capital Expenditures: $0
• Strategic Investments:
  • Grant income recognized in 2025: $900,014 from CPRIT AML Grant, $118,478 from FDA Grant, $472,208 from SBIR AML Grant, $391,305 from Decoy Grant, $665,000 from SBIR NHL Grant, $425,670 from PANACEA Grant, and $573,994 from CPRIT Pancreatic Grant.
  • Total grant income recognized in 2025 was $3,546,669.

Business Segment Analysis

Marker Therapeutics, Inc. operates as a single reportable segment, focusing on the discovery, development, and commercialization of T cell-based immunotherapies. The Company's product candidates are MT-601 (autologous) and MT-401-OTS (Off-the-Shelf).

MT-601 (Autologous MAR-T cell product)

Financial Performance:

• Revenue: Grant income recognized for SBIR NHL Grant was $665,000 in 2025 and $665,000 in 2024. Grant income recognized for PANACEA Grant was $425,670 in 2025 and $7,177 in 2024. Grant income recognized for CPRIT Pancreatic Grant was $573,994 in 2025 and $0 in 2024.
• Operating Margin: Not segment-specific.
• Key Growth Drivers: The Phase 1 APOLLO study for relapsed lymphoma patients has shown objective responses and a favorable safety profile, leading to its advancement to the dose expansion phase. For pancreatic cancer, a prior Phase 1/2 trial demonstrated encouraging objective clinical responses and an 84.6% disease control rate. MT-601 has received orphan drug designation for pancreatic cancer.

Product Portfolio:

• MT-601 for Lymphoma: Targets six tumor antigens (Survivin, PRAME, WT1, NY-ESO-1, SSX-2, MAGEA-4).
• MT-601 for Pancreatic Cancer: Targets five tumor associated antigens.

Market Dynamics: MT-601 addresses a high unmet medical need in lymphoma patients who have relapsed after or are ineligible for anti-CD19 CAR-T cell therapy. It is currently the only natural T cell product targeting multiple tumor antigens for this patient population. In pancreatic cancer, it targets locally advanced, unresectable or metastatic disease, a challenging indication.

MT-401-OTS Program (Off-the-Shelf MAR-T cell product)

Financial Performance:

• Revenue: Grant income recognized for CPRIT AML Grant was $900,014 in 2025 and $4,411,149 in 2024. Grant income recognized for FDA Grant was $118,478 in 2025 and $519,750 in 2024. Grant income recognized for SBIR AML Grant was $472,208 in 2025 and $982,182 in 2024.
• Operating Margin: Not segment-specific.
• Key Growth Drivers: The MT-401-OTS program offers the potential for a rapid treatment option (as fast as 72 hours) for patients with rapidly progressing diseases like AML or MDS. Its manufacturing approach, utilizing commercially available leukapheresis material from healthy donors, is designed for scalability and lower per-dose cost, with a single donor potentially providing treatment for approximately 40 patients. Preliminary safety data from the first patient treated in October 2025 has been encouraging.

Product Portfolio:

• MT-401-OTS: Initially investigated in AML or MDS, with potential for expansion to other indications.

Market Dynamics: This program targets patients with AML or MDS, offering a potentially faster and more accessible treatment option compared to autologous therapies. MT-401 has received orphan drug designation for AML from both the FDA and the European Medicines Agency.

Capital Allocation Strategy

Shareholder Returns:

• Share Repurchases: Marker Therapeutics, Inc. did not repurchase any equity securities during the years ended December 31, 2025, or 2024.
• Dividend Payments: No cash dividends have been declared or paid on common stock, and the Company does not anticipate declaring or paying cash dividends for the foreseeable future.
• Future Capital Return Commitments: None disclosed.

Balance Sheet Position:

• Cash and Equivalents: $17,042,847 (as of December 31, 2025)
• Total Debt: None disclosed.
• Net Cash Position: $17,042,847 (as of December 31, 2025)
• Credit Rating: Not disclosed.
• Debt Maturity Profile: Not applicable, as no debt is disclosed.

Cash Flow Generation:

• Operating Cash Flow: $(12,014,081) (2025)
• Free Cash Flow: Not explicitly disclosed, but given nil capital expenditures, it approximates operating cash flow.
• Cash Conversion Metrics: Not explicitly disclosed.

Operational Excellence

Production & Service Model: Marker Therapeutics, Inc. is a clinical-stage company and does not operate its own cGMP manufacturing facility. Its MAR-T cell manufacturing process involves drawing blood from patients or healthy donors, isolating peripheral blood mononuclear cells (PBMCs), and co-culturing them with GMP-grade cytokines and overlapping peptide libraries. This process selectively expands T cells specific for target antigens. The resulting product, a mix of helper (CD4+) and cytotoxic (CD8+) T cells, is tested for identity, sterility, phenotype, and functionality before being frozen and transported for infusion. The Company has optimized its manufacturing process, reducing the total manufacturing time from 36 days (in Baylor College of Medicine studies) to 9 days, which has resulted in increased antigen specificity, diversity, and a four-fold increase in potency in vitro.

Supply Chain Architecture: Key Suppliers & Partners:

• Research & Development/Clinical Supply: Baylor College of Medicine - continues to provide services for research and development, product supply for clinical trials, and support including personnel and space.
• Manufacturing Partners:
  • Cellipont Bioservices - engaged on June 16, 2025, for technology transfer and cGMP manufacturing services for MT-601, in anticipation of larger pivotal trials and commercial scale production.
  • Wilson Wolf Manufacturing Corporation - supplied cell culture devices in 2025.
  • Cell Ready - former contract development and manufacturing organization; Master Services Agreement terminated March 27, 2025.
• Technology Partners: Baylor College of Medicine - exclusive worldwide license for MAR-T cell technology.

Facility Network:

• Manufacturing: Relies entirely on third-party contract manufacturing organizations (CMOs).
• Research & Development: Collaborates with Baylor College of Medicine's Center for Cell and Gene Therapy.
• Distribution: Not yet established for commercialization.

Operational Metrics:

• Manufacturing Time Reduction: From 36 days to 9 days.
• In Vitro Potency Increase: Four-fold with optimized manufacturing process.
• Off-the-Shelf Donor Capacity: A single healthy donor could provide treatment for approximately 40 patients.

Market Access & Customer Relationships

Go-to-Market Strategy: Marker Therapeutics, Inc. is in the clinical development stage and has not yet established a commercial sales, marketing, or distribution organization. Upon potential regulatory approval of its product candidates, the Company expects to either build its own commercial capabilities or enter into strategic collaborations with third parties to perform these services.

Customer Portfolio:

• Enterprise Customers: Not applicable, as the Company is clinical-stage and has no approved products for commercial sale.
• Strategic Partnerships: The Company maintains a strategic alliance with Baylor College of Medicine for preclinical research, early-stage clinical trials, and Phase 2 clinical trials, as well as continued access to clinical data and product manufacturing support. It also has grant agreements with the Cancer Prevention & Research Institute of Texas (CPRIT), the FDA Orphan Products Grant program, and the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program, which provide funding for its clinical investigations.
• Customer Concentration: Not applicable.

Geographic Revenue Distribution: All current revenue is derived from grants, primarily from U.S. federal and state agencies (FDA, NIH, CPRIT). Clinical trials are conducted in the United States.

Competitive Intelligence

Market Structure & Dynamics

Industry Characteristics: The biotechnology and immunotherapy industries are characterized by rapid technological advancements and intense competition. There is a significant unmet need in cancer therapeutics, particularly for patients with relapsed or refractory disease. The field of adoptive cell transfer, including CAR-T and TCR-engineered T cells, is a rapidly evolving area. Tumors are heterogeneous and can develop mechanisms to evade immune detection, necessitating therapies that can target multiple antigens. The regulatory approval process for novel cell therapies is lengthy, complex, expensive, and often unpredictable.

Competitive Positioning Matrix:

Direct Competitors

Primary Competitors:

• CD19-directed CAR-T cell therapies: Yescarta, Kymriah, Tecartus, and Bryanzi are approved for relapsed lymphoma. Marker Therapeutics, Inc.'s MT-601 targets patients who have failed or are ineligible for these therapies, offering an alternative with a potentially improved safety profile.
• Other T cell immunotherapies: Includes non-CD19 targeting CAR-T cells, multi-targeted CAR-T cells, and NK-CAR therapies.
• Bispecific antibodies: Emerging therapies in the oncology space, including for lymphoma.

Emerging Competitive Threats: The Company faces competition from other drug development technologies and methods, new small molecules, and other classes of therapeutic agents. New entrants and disruptive technologies could also pose threats.

Competitive Response Strategy: Marker Therapeutics, Inc.'s strategy focuses on expediting clinical development and regulatory approval of its highly differentiated MAR-T cell therapies. It aims to optimize its manufacturing process, product quality, and commercial scalability through collaborations with third parties. The Company plans to explore new product opportunities by expanding and customizing targeted antigens and optimizing dosing regimens. It also intends to leverage the expertise of its scientific founders, advisors, and institutional partners like Baylor College of Medicine. The Company believes its non-engineered T cell therapy approaches may be synergistic with and improve upon therapies developed by competitors.

Risk Assessment Framework

Strategic & Market Risks

Market Dynamics:

• Clinical Stage Company: Marker Therapeutics, Inc. is a clinical-stage company with a history of operating losses and no approved products, expecting losses to continue indefinitely. This raises substantial doubt about its ability to continue as a going concern.
• Regulatory Approval Process: The FDA regulatory approval process is lengthy, time-consuming, and unpredictable, especially for novel cell therapies. The Company has no prior experience submitting a Biologics License Application (BLA).
• Clinical Trial Outcomes: Preclinical and early-stage clinical trial results may not be predictive of future outcomes. Clinical trials are expensive, complex, and subject to delays (e.g., patient enrollment, manufacturing, regulatory holds, unforeseen safety issues).
• Competition: The biotechnology and immunotherapy industries are highly competitive, with many companies possessing greater financial and technical resources, potentially leading to the development of more effective or earlier-to-market products.
• Limited Market Opportunities: Initial target patient populations for product candidates (e.g., relapsed/refractory patients) may be small, potentially limiting revenue generation.
• Biosimilar Competition: New regulatory pathways for biosimilars could reduce the duration of market exclusivity for future approved products.

Technology Disruption: The rapid pace of technological developments in the biotechnology and immunotherapy industries means that current or proposed immunotherapies could become obsolete.

Operational & Execution Risks

Supply Chain Vulnerabilities:

• Third-Party Manufacturing Reliance: The Company relies on third-party contract manufacturing organizations (CMOs) like Baylor College of Medicine and Cellipont Bioservices for cGMP manufacturing, as it does not own its manufacturing facilities.
• Capacity and Quality Risks: There is no guarantee that third-party manufacturers will meet required capacities, timelines, or quality standards, or that they will not experience disruptions (e.g., cost overruns, equipment failures, labor shortages, natural disasters, competition with other clients).
• Sole-Source/Limited Vendors: Dependence on a limited number of vendors for specialized equipment and materials (e.g., Wilson Wolf Manufacturing Corporation) creates supply chain risk.
• Manufacturing Complexity: The manufacturing process for biologics is complex, highly regulated, and susceptible to product loss or failure due to logistical issues, variability in starting materials, contamination, or equipment/operator error.
• Process Development Risk: The new 9-day manufacturing process is new and subject to uncertainties regarding commercial viability, cost reduction, and scalability.
• Chain of Identity: Maintaining a chain of identity for autologous therapies (MT-601) is complex, and failure could lead to adverse patient outcomes or regulatory action.

Financial & Regulatory Risks

Market & Financial Risks:

• Going Concern Uncertainty: The Company's history of losses and anticipated cash burn raise substantial doubt about its ability to continue as a going concern beyond Q4 2026 without additional funding.
• Capital Needs: Substantial additional funding is required for ongoing R&D and potential commercialization. Inability to raise capital on favorable terms could force delays or termination of programs.
• Stock Price Volatility: The Company's stock price is subject to significant fluctuations due to clinical development risks, market conditions, competitive developments, and financing activities.
• Dilution: Future equity financings will dilute existing shareholder ownership.
• Product Liability: Inherent risk of product liability claims from clinical testing and commercialization, potentially leading to substantial liabilities not fully covered by insurance.
• Global Economic Conditions: Unfavorable global economic conditions, including inflation and recession concerns, could adversely affect the Company's ability to raise capital and increase operating costs.

Regulatory & Compliance Risks:

• Extensive Regulation: Subject to comprehensive and evolving regulations by the FDA and foreign authorities across all stages of product development and commercialization. Non-compliance can result in severe penalties.
• Healthcare Laws: Subject to federal and state healthcare fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act, HIPAA, Physician Payments Sunshine Act), which restrict business practices and can lead to significant penalties for non-compliance.
• Healthcare Reform: Legislative and regulatory changes (e.g., ACA, IRA, OBBBA) aimed at cost containment could negatively impact product pricing, coverage, and reimbursement.
• Data Privacy & Security: Stringent and changing data privacy and security laws (e.g., HIPAA, CCPA, EU GDPR) pose risks of regulatory investigations, litigation, fines, and reputational harm if compromised.
• Internal Controls: As a public company, obligated to maintain effective internal controls over financial reporting; failure could adversely affect investor confidence.

Geopolitical & External Risks

Geopolitical Exposure: Geopolitical events, such as military conflicts, could disrupt operations, supply chains, and financial markets. Catastrophic Events: Major natural disasters, cyberattacks, war, terrorism, or health epidemics/pandemics could severely disrupt business operations, manufacturing, and clinical trials.

Innovation & Technology Leadership

Research & Development Focus: Core Technology Areas:

• Multi Antigen Recognizing (MAR)-T cell technology: Focuses on selectively expanding natural tumor-specific T cells that recognize multiple tumor associated antigens (TAAs) without genetic modification. This approach aims to provide broad-spectrum anti-tumor activity and limit tumor escape by targeting up to six antigens simultaneously.
• Non-genetically engineered T cells: Leverages the native T cell receptor, which is believed to offer a cost-effective and non-toxic strategy compared to gene-modified CAR-T and TCR-engineered T cells.
• Manufacturing Process Optimization: Significant R&D efforts have reduced manufacturing time from 36 days to 9 days, resulting in a four-fold increase in in vitro potency and enhanced antigen specificity and diversity.
• Combination Therapies: Actively assessing the potential of combining MAR-T cell products with other therapeutic agents to expand cancer target recognition.
• Off-the-Shelf (OTS) Development: Advancing MT-401-OTS using healthy donor material to enable faster treatment, broader scalability, and lower per-dose costs.

Innovation Pipeline:

• MT-601: In clinical development for lymphoma (Phase 1 APOLLO study, advancing to dose expansion) and pancreatic cancer (Phase 1 PANACEA study).
• MT-401-OTS: In clinical development for AML or MDS (Phase 1 RAPID study, first patient treated).
• The Company plans to explore new product opportunities by customizing and increasing the number of targeted antigens to expand indications, and to initiate additional clinical trials in other tumor types based on emerging data.

Intellectual Property Portfolio:

• Patent Strategy: Holds an exclusive worldwide license from Baylor College of Medicine for three patent families, including European patent EP 2470644 (estimated expiration August 24, 2030). Patent applications cover methods of generating multi-antigen specific T cell products and their therapeutic uses.
• Licensing Programs: The core intellectual property is in-licensed from Baylor College of Medicine, involving milestone payments and royalties on net sales.
• IP Litigation: Not currently involved in material IP litigation, but acknowledges the inherent risks of challenges to patent validity, enforceability, and potential infringement claims in the biotechnology sector.

Technology Partnerships:

• Strategic Alliances: Baylor College of Medicine is a key strategic partner, providing an exclusive license, sponsored research, clinical supply, workforce grants, and clinical trial agreements.
• Research Collaborations: Engages in research collaborations with Baylor College of Medicine's Center for Cell and Gene Therapy.

Leadership & Governance

Executive Leadership Team

Leadership Continuity: The Company is highly dependent on Juan Vera, M.D., who holds multiple key executive roles. The loss of Dr. Vera's services could significantly harm the business and its relationship with Baylor College of Medicine. The Company prioritizes training additional qualified scientific and medical personnel to ensure business continuity.

Board Composition:

• N. David Eansor (Chairman)
• Katharine Knobil (Director)
• Steve Elms (Director)
• Kathryn Penkus Corzo (Director, appointed effective November 1, 2025) The Board of Directors addresses cybersecurity risk management as part of its general oversight function. The Company states that 100% of its executive officers are women or self-identify as a member of an underrepresented minority group.

Human Capital Strategy

Workforce Composition:

• Total Employees: As of December 31, 2025, Marker Therapeutics, Inc. had 5 full-time employees, comprising 1 in clinical roles and 4 in administrative support.
• Geographic Distribution: Not explicitly detailed beyond the principal executive offices in Houston, Texas.
• Skill Mix: The Company emphasizes the importance of attracting and retaining highly qualified managerial, scientific, and medical personnel.

Talent Management: Acquisition & Retention:

• Hiring Strategy: Objectives include identifying, recruiting, retaining, incentivizing, and integrating existing and additional employees.
• Retention Metrics: Not disclosed.
• Employee Value Proposition: Utilizes equity incentive plans to attract, retain, and motivate selected employees, consultants, and directors through equity-based compensation awards.

Diversity & Development:

• Diversity Metrics: The Company states a commitment to diversity, equity, and inclusion, noting that 100% of its executive officers are women or self-identify as a member of an underrepresented minority group.
• Development Programs: Includes leadership development initiatives and career advancement as part of its human capital objectives.
• Culture & Engagement: Strives to create a diverse environment.

Regulatory Environment & Compliance

Regulatory Framework:

• Industry-Specific Regulations: Marker Therapeutics, Inc. is subject to extensive and rigorous regulation by the FDA in the United States and comparable authorities in foreign countries. This regulation covers all aspects of its biologics, including research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring, and reporting.
• International Compliance: Obtaining regulatory approval in one jurisdiction does not guarantee approval in others. Compliance with foreign regulatory requirements can involve significant delays, difficulties, and costs. MT-401 has received orphan drug designation from the European Medicines Agency (EMA).
• Trade & Export Controls: Not explicitly detailed beyond general risk factor mentions.

Legal Proceedings: Marker Therapeutics, Inc. is not currently a party to any material legal proceedings that are believed to have an adverse effect on its business, operating results, or financial condition. However, the Company may become involved in legal proceedings in the ordinary course of business.

Tax Strategy & Considerations

Tax Profile:

• Effective Tax Rate: The Company reported no federal income tax expense for the years ended December 31, 2025, and 2024, due to operating losses. It recognized a state tax benefit of $(15,156) in 2025 and a state tax expense of $49,953 in 2024.
• Geographic Tax Planning: Not explicitly detailed.
• Tax Reform Impact: The One Big Beautiful Bill Act (OBBBA), enacted July 4, 2025, introduced changes to U.S. tax law, including provisions on bonus depreciation and research and experimental expenditures. Due to the Company's full valuation allowance position, the OBBBA did not have a material impact on its financial statements for 2025. The Inflation Reduction Act of 2022 and other federal/state reforms could affect future pricing, coverage, and reimbursement.

Tax Loss and Credit Carryforwards:

• Federal Net Operating Loss (NOL) Carryforwards: Approximately $186.8 million as of December 31, 2025. Of this, $38.4 million will expire between 2030 and 2037, while $148.4 million (generated from 2018 onwards) carry forward indefinitely but are subject to an 80% limitation on taxable income.
• State NOL Carryforwards: Approximately $38.6 million as of December 31, 2025. Of this, $21.9 million will begin to expire in 2035, while $16.7 million (generated from 2018 onwards) carry forward indefinitely, subject to an 80% limitation on taxable income.
• Research and Development Tax Credit Carryforwards: $0.7 million federal and $0.1 million state, beginning to expire in 2030.
• Section 382 Limitations: The usage of NOL carryforwards may be limited due to potential ownership changes under Section 382 of the Internal Revenue Code.
• Valuation Allowance: A 100% valuation allowance of $43.3 million (2025) and $41.0 million (2024) has been established against deferred tax assets due to the Company's history of losses and uncertainty regarding future realization.
• Unrecognized Tax Benefits: No liability for unrecognized tax benefits was required as of December 31, 2025, and 2024.
• Tax Audits: Income tax returns for 2022 to 2024 are open and subject to audit.

Insurance & Risk Transfer

Risk Management Framework:

• Insurance Coverage: Marker Therapeutics, Inc. maintains products and clinical trial liability insurance policies to mitigate risks associated with clinical testing and potential future commercialization. The Company also carries cybersecurity insurance to cover expenses related to breach events (e.g., notification, credit monitoring, investigation, crisis management, public relations, legal advice) and property and casualty insurance that may cover data restoration, physical damage, or third-party injuries resulting from cybersecurity incidents.
• Risk Transfer Mechanisms: Not explicitly detailed beyond insurance coverage.