Semper Paratus Acquisition Corporation Warrant

Company Overview

Business Model: Tevogen Bio Holdings Inc. is a clinical-stage specialty immunotherapy company focused on developing off-the-shelf, precision T cell therapies. The company harnesses CD8+ cytotoxic T lymphocytes (CTLs) to treat infectious diseases, cancers, and other disorders. Its core technology, ExacTcell, involves processes and methodologies to develop, enrich, and expand single human leukocyte antigen (HLA)-restricted CTL therapies with precisely defined targets. The company aims to provide commercially attractive, economically viable, and cost-effective personalized T cell therapies, with a focus on allogeneic therapeutics derived from third-party donors.

Market Position: Tevogen Bio Holdings Inc. aspires to be a leader in mainstreaming cell therapy through its ExacTcell technology, which it believes represents a significant scientific breakthrough. The company's approach utilizes naturally occurring, genetically unmodified CTLs designed to recognize multiple, distinct antigens, aiming to circumvent the impact of mutations seen with single-target treatments. This high specificity is intended to reduce cross-reactivity and adverse impacts on healthy cells. The company faces intense competition from major pharmaceutical, specialty pharmaceutical, and biotechnology companies, as well as academic and research institutions, many of which have greater financial resources and expertise.

Recent Strategic Developments:

• Clinical Trial Completion: Completed a Phase 1 proof-of-concept clinical trial for TVGN 489, its lead product candidate for COVID-19, in January 2023. Results were published in Blood Advances in June 2024.
• Pivotal Trial Planning: Planning a pivotal trial for TVGN 489 in COVID-19 patients with B cell malignancies, with further studies for other vulnerable populations and Long COVID prevention/treatment.
• Pipeline Expansion: Leveraging ExacTcell technology to develop product candidates for HPV-related diseases (TVGN 920 for cervical cancer, TVGN 960 for oropharyngeal cancer), Hepatitis B (TVGN 116), Epstein-Barr virus (EBV)-associated lymphomas (TVGN 930), and EBV-related Multiple Sclerosis (TVGN 601).
• Manufacturing Initiatives: Actively pursuing the acquisition or construction of manufacturing and research and development facilities, potentially through collaboration with a facility development partner, to establish in-house clinical and commercial supply capabilities.
• Artificial Intelligence Initiative: Launched Tevogen.AI in October 2023 to expedite drug development, optimize laboratory processes and clinical trials, and improve patient outcomes using AI-powered target detection and data analysis. The company has filed patents for related algorithms.
• Business Combination: Completed a business combination with Semper Paratus Acquisition Corporation on February 14, 2024, resulting in Tevogen Bio Holdings Inc. becoming the parent entity.

Geographic Footprint:

• Corporate Headquarters: Warren, New Jersey (6,708 square feet, lease expires February 14, 2026).
• Research & Development Facilities: Two locations in Philadelphia, Pennsylvania: a 3,620 square foot center (lease expires June 30, 2025) and a shared facility for preclinical and pharmacodynamic activities.
• The company anticipates expanding its corporate and R&D facilities and developing in-house manufacturing capabilities.

Financial Performance

Revenue Analysis

Profitability Metrics:

• Gross Margin: Not applicable due to no revenue.
• Operating Margin: Not applicable due to no revenue.
• Net Margin: Not applicable due to no revenue.

Investment in Growth:

• R&D Expenditure: $31.0 million (609.1% increase from $4.4 million in 2023)
• Capital Expenditures: $0 (2024), $0.1 million (2023)
• Strategic Investments:
  • $2.0 million from the sale of Series A Preferred Stock (2024).
  • $6.0 million from the sale of Series C Preferred Stock (2024).
  • $3.0 million in non-refundable prepaid proceeds for anticipated Series A-1 Preferred Stock issuance (2024).
  • $1.0 million drawn under a Loan Agreement with The Patel Family, LLP (2024).
  • $2.0 million grant received from KRHP LLC in January 2025.
  • Committed additional $8.0 million grant from KRHP LLC expected in Q2 2025.
  • Loan Agreement with The Patel Family, LLP provides access to an unsecured line of credit facility of up to $36.0 million, allowing monthly draws of $1.0 million over 36 months.

Business Segment Analysis

Tevogen Bio Holdings Inc. operates in one operating segment, focused on the global discovery, development, and commercialization of proprietary therapeutics. The company's business activities are managed on a consolidated basis, with all expenses incurred from the development of product candidates like TVGN 489, which targets various disease indications.

Capital Allocation Strategy

Shareholder Returns:

• Share Repurchases: Repurchased all outstanding Series B Preferred Stock from the Sponsor in June 2024, in exchange for the Sponsor's release from assumed liabilities, with no cash consideration.
• Dividend Payments: No cash dividends have been paid on common stock. Series A Preferred Stock carries an annual 5% cumulative dividend, increasing by 2% each year. Series C Preferred Stock carries an annual 7.5% cumulative dividend, compounded annually, payable in Series C shares or, at the company's election, in cash.
• Dividend Yield: Not applicable for common stock.
• Future Capital Return Commitments: No explicit future capital return commitments for common shareholders were disclosed.

Balance Sheet Position (as of December 31, 2024):

• Cash and Equivalents: $1.3 million
• Total Debt: $2.65 million (comprising $1.0 million from the Loan Agreement and $1.65 million in Notes Payable)
• Net Cash Position: $(1.37) million
• Credit Rating: Not disclosed.
• Debt Maturity Profile:
  • Notes Payable: $1.65 million (overdue as of December 31, 2024).
  • Loan Agreement: $1.0 million drawn (matures July and August 2028). An additional $2.0 million was drawn in February and March 2025 (maturing February and March 2029, respectively). The facility has a remaining capacity of $26.0 million as of April 2, 2025.

Cash Flow Generation (Year ended December 31, 2024):

• Operating Cash Flow: $(12.0) million
• Free Cash Flow: Not explicitly calculated, but negative given operating cash flow and minimal capital expenditures.
• Cash Conversion Metrics: Not explicitly disclosed.

Operational Excellence

Production & Service Model: Tevogen Bio Holdings Inc.'s operational philosophy centers on its ExacTcell technology, which focuses on the selection and expansion of naturally occurring, genetically unmodified CD8+ cytotoxic T lymphocytes (CTLs). The process involves collecting cells from healthy donors, exposing T cells to preselected targeted peptides, and through repetitive selection and expansion, producing CD8+ CTLs specific for these targets. The goal is to generate over 100, and up to hundreds, of doses from a single donor, enabling off-the-shelf availability. Therapies are designed for rapid, brief intravenous administration in an ambulatory setting.

Supply Chain Architecture: Key Suppliers & Partners:

• Clinical Manufacturing: Thomas Jefferson University - Manufactured TVGN 489 for the Phase 1 proof-of-concept trial.
• Analytical Services: Adaptive Biotechnologies - Conducted analyses to evaluate the persistence of infused TVGN 489 cells in patients.
• AI Technology Partners: Microsoft for Startups program and Microsoft Azure - Utilized for the Tevogen.AI initiative. The company has also entered into agreements with other leading artificial intelligence and technology companies for this initiative. Facility Network:
• Manufacturing: Currently relies on third-party manufacturing for clinical supply. The company is actively working to establish its own manufacturing capabilities through the acquisition or construction of facilities, potentially in collaboration with a facility development partner, to support future clinical and commercial needs.
• Research & Development: Operates two R&D facilities in Philadelphia, Pennsylvania, including a 3,620 square foot center and a shared laboratory space dedicated to preclinical and pharmacodynamic activities.
• Distribution: The company's "off-the-shelf" strategy aims for convenient and cost-efficient delivery, potentially eliminating the need for specialized medical facilities and allowing administration in ambulatory settings.

Operational Metrics:

• Cell Expansion: TVGN 489 cells are expanded by 600-fold or more from donor cells during the manufacturing process.
• Target Retention: More than 95% of the targets for the HLA-A*02:01 TVGN 489 product have remained intact through the first quarter of 2025, demonstrating resilience to viral mutations.
• Cell Persistence: In the Phase 1 clinical trial, infused TVGN 489 cells were detected in patients' peripheral blood for at least six months after treatment.

Market Access & Customer Relationships

Go-to-Market Strategy: Tevogen Bio Holdings Inc. plans to commercialize TVGN 489 and its other product candidates globally, targeting large patient populations. The company's commercial and market access team collaborates with research and development and external experts to understand market dynamics, identify unmet needs, map the patient journey, and analyze competition. The strategy involves identifying potential collaboration and service partners, including distribution partners for its cryopreserved cell therapy products. The company emphasizes patient centricity and aims to collaborate with all stakeholders, including patients, healthcare professionals, sales channel partners, public and private payers, and service providers. Essential commercial capabilities such as market analytics, pricing, and commercial operations are continuously being developed.

Customer Portfolio: Target Patient Populations (U.S. estimates):

• TVGN 489 (COVID-19 & Long COVID):
  • Approximately 750,000 patients with B cell hematologic cancer.
  • Approximately 2,175,000 addressable patients with other cancers (lung, breast, colon, pancreatic, liver).
  • Approximately 18 million addressable patients with Long COVID.
• TVGN 920 (HPV-related diseases): Approximately 5.5 million patients with high-risk HPV infections, with 200,000 diagnosed with high-grade dysplasia per year.
• TVGN 930 (EBV-associated lymphomas): Approximately 92,000 patients.
• TVGN 960 (HPV-related mouth and throat cancer): Approximately 110,000 patients.
• TVGN 601 (EBV-related multiple sclerosis): Approximately 1 million patients.
• TVGN 116 (Hepatitis B): Approximately 500,000 to 1 million patients with high-risk chronic Hepatitis B for prevention of liver cancer. Customer Concentration: Not explicitly disclosed, but the company targets broad patient populations across multiple disease areas.

Geographic Revenue Distribution: The company has not yet generated any revenue. It plans for global commercialization of its product candidates upon regulatory approval.

Competitive Intelligence

Market Structure & Dynamics

Industry Characteristics: The biotechnology industry, particularly the cell therapy sector, is characterized by rapid technological evolution, evolving understanding of disease etiology, intense competition, and robust pursuit and defense of intellectual property. The market for AI in drug discovery is also rapidly changing. Competitive Positioning Matrix:

Direct Competitors

Primary Competitors:

• COVID-19 Therapeutics:
  • Pfizer (Nirmatrelvir with Ritonavir (Paxlovid)): FDA-approved antiviral for high-risk individuals, but associated with drug-drug interactions, COVID-19 rebound (up to 21% in ambulatory patients), and must be started within five days of symptom onset. Limited specific authorization for immunocompromised patients.
  • Gilead Science (Veklury (remdesivir)): FDA-approved antiviral, intravenous administration requiring multiple daily infusions, associated with liver enzyme abnormalities and gastrointestinal side effects.
  • Invivyd (Pemgarda (pemivibart)): Monoclonal antibody with Emergency Use Authorization for COVID-19 prevention in immunocompromised individuals. Vulnerable to novel viral mutations, with observed increased inhibitory concentrations for neutralization against certain circulating strains.
  • OneBlood (High-titer COVID-19 convalescent plasma (CCP)): Provides passive immunity, but data in humorally suppressed individuals is limited, and questions remain regarding widespread availability and effectiveness in specific subgroups.
• Virus-Specific T Cell Therapies:
  • Atara Biotherapeutics (Ebvallo (tabelecleucel)): Approved in Europe for rare EBV-caused hematologic cancer. Its ATA188 (targeting EBV-infected B cells/plasma cells in MS) failed to meet efficacy or biomarker endpoints in Phase 2.
  • AlloVir, Inc.: Developing allogeneic T cell therapies for viral diseases. Conducted a Phase 1b trial for COVID-19 but has not continued clinical development.

Emerging Competitive Threats: New entrants, disruptive technologies, and alternative solutions are continuously emerging in the biopharmaceutical and AI sectors. The rapid evolution of AI technologies also presents a competitive threat if Tevogen Bio Holdings Inc. cannot adapt and develop these technologies effectively.

Competitive Response Strategy: Tevogen Bio Holdings Inc. focuses on addressing critical unmet needs in COVID-19 therapeutics for immunocompromised and high-risk elderly patients, and Long COVID sufferers. Its TVGN 489 product is designed to be less susceptible to viral mutations and drug resistance compared to monoclonal antibodies and antivirals. The company's proprietary approach allows for ongoing monitoring and potential adjustment of products to recognize new viral variants. It aims for fast-acting, single outpatient infusions. The company is also diversifying its pipeline using ExacTcell technology across virology, oncology, and neurology, and leveraging its Tevogen.AI initiative to accelerate product development and maintain a competitive edge.

Risk Assessment Framework

Strategic & Market Risks

• Market Dynamics: The regulatory landscape for cellular therapy is rigorous, complex, uncertain, and subject to change, potentially leading to heightened scrutiny and delays. The company's novel T cell therapy approach is unproven and may not result in marketable products.
• Technology Disruption: The rapid evolution of AI technologies requires significant resources for design, development, testing, and maintenance, with risks of incorrect design, improper operation, or data rights issues.
• Customer Concentration: The commercial success of product candidates depends on significant market acceptance among physicians, patients, healthcare payors, and the medical community, which may not be achieved.
• Market Opportunity: Estimates of target patient populations are based on third-party sources and may be inaccurate, potentially leading to a smaller addressable market than anticipated.
• Competition: Intense competition from companies with greater financial resources and expertise could result in competitors developing superior products or obtaining regulatory approvals faster.

Operational & Execution Risks

• Supply Chain Vulnerabilities: Reliance on third-party suppliers for key manufacturing materials poses risks related to pricing, availability, quality, and delivery schedules, potentially leading to supply interruptions.
• Capacity Constraints: The manufacture of cell therapies is complex, highly regulated, and susceptible to product loss due to contamination, equipment failure, and human error. Establishing in-house manufacturing capabilities requires significant time and expense and may not be successful.
• Clinical Trial Execution: Limited experience in designing and implementing preclinical and clinical trials, which are complex, expensive, and time-consuming. Difficulties in patient enrollment, changes in manufacturing/formulation, or negative/inconclusive results could delay or terminate development.
• Third-Party Reliance: Dependence on CROs, CMOs, and clinical investigators for preclinical studies and clinical trials means their failure to perform contractual duties or comply with regulations could materially harm the business.
• Growth Management: Expected growth in organization size will impose significant responsibilities on management, potentially diverting attention from day-to-day activities.
• Product Liability: Inherent risk of product liability lawsuits from clinical trials and commercialized products, potentially leading to substantial liabilities and limiting commercialization.

Financial & Regulatory Risks

• Need for Additional Capital: The company has a limited operating history, no product sales revenue, and a history of significant losses. Substantial additional financing is required to achieve business objectives, which may not be available on acceptable terms or at all, potentially forcing delays or termination of development programs.
• Regulatory Approval: The FDA approval process is lengthy and time-consuming. There is no guarantee that product candidates will receive regulatory approval, or that RMAT designation will expedite the process or increase approval likelihood.
• Post-Approval Compliance: Even if approved, products will be subject to extensive ongoing regulatory requirements, including manufacturing, labeling, advertising, and post-market surveillance, which can incur significant additional expense and lead to restrictions or withdrawal of approval if not maintained.
• Healthcare Reform: Legislative and regulatory changes (e.g., ACA, Inflation Reduction Act) could negatively impact the ability to sell products profitably through reduced reimbursement, pricing pressures, or increased compliance costs.
• Healthcare Fraud & Abuse: Operations may be subject to federal and state healthcare fraud and abuse laws, false claims laws, and health information privacy and security laws. Non-compliance could result in substantial penalties.
• Tax Strategy: The ability to use net operating loss carryforwards to offset future taxable income may be subject to limitations (e.g., Section 382 of the Internal Revenue Code).

Geopolitical & External Risks

• Geographic Dependencies: Not explicitly detailed, but global commercialization plans imply exposure to international regulatory and market conditions.
• Government Agency Disruptions: Disruptions at FDA and other government agencies (e.g., funding shortages, shutdowns) could hinder or prevent timely product development and commercialization.
• Environmental, Health and Safety: Compliance with environmental, health, and safety laws and regulations is required, with risks of fines or penalties from hazardous materials.

Innovation & Technology Leadership

Research & Development Focus: Core Technology Areas:

• ExacTcell Technology: Investment in developing, enriching, and expanding single HLA-restricted CD8+ CTL therapies. Strategic importance lies in creating off-the-shelf, precision T cell therapies that are genetically unmodified and target multiple, distinct antigens to overcome viral and cancer mutations.
• Innovation Pipeline:
  • TVGN 489: Lead product candidate for COVID-19 (treatment for immunocompromised/high-risk elderly, prevention/treatment of Long COVID).
  • Virology: Product candidates targeting HPV-related diseases (TVGN 920 for cervical cancer, TVGN 960 for oropharyngeal cancer) and Hepatitis B (TVGN 116).
  • Oncology: Developing EBV-associated lymphomas (TVGN 930) and exploring novel techniques to combat cancers with T cell therapy, potentially overcoming limitations of checkpoint inhibitors.
  • Neurology: Developing EBV-specific CTLs for Multiple Sclerosis (TVGN 601).
  • T cell Vaccination: Early investigative work is underway to develop T cell vaccinations for preventative use.
• Tevogen.AI Initiative: Focuses on harnessing artificial intelligence to expedite drug development, optimize laboratory processes and clinical trials, unravel complex biological data, and improve patient outcomes. Specifically exploring AI-powered target detection to accelerate product development.

Intellectual Property Portfolio (as of February 24, 2025):

• Patent Strategy: The company relies on a combination of patents, patent applications, trademarks, and trade secrets to protect its proprietary position, continuously reassessing claim scope for maximum coverage.
• Patent Holdings:
  • U.S. Patents: Three issued U.S. utility patents related to TVGN 489 (methods of treating COVID-19 infection, COVID-19 peptide-specific CTLs, and methods of manufacturing COVID-19 peptide-specific CTLs), all expiring on December 9, 2040.
  • Pending U.S. Patent Applications: Nine applications, including two related to COVID-19 treatment, six related to other viruses or cancer, and one related to artificial intelligence-driven T cell target identification and receptor engagement. Anticipated expiration dates through December 16, 2044.
  • Ex-U.S. Patent Applications: Thirteen applications in various jurisdictions (Australia, Canada, Europe, Japan, Qatar, United Arab Emirates, and Patent Cooperation Treaty) covering viral specific T cells, methods of treating and preventing viral infections, methods for developing CD3+CD+ cells, and systems for predicting immunologically active peptides with machine learning models.
• Licensing Programs: Not explicitly detailed.
• IP Litigation: Not currently a party to any material pending legal proceedings.

Technology Partnerships:

• Strategic Alliances: Entered into agreements with leading artificial intelligence and technology companies, including enrollment in the Microsoft for Startups program and use of Microsoft Azure, to aid the Tevogen.AI initiative. These collaborations provide access to experts and resources for creating foundational algorithmic models of T cell interactions with proteins.

Leadership & Governance

Executive Leadership Team

Leadership Continuity: The company is highly dependent on its key personnel, and the loss of any executive officer or key employee could adversely impact objectives. The company does not have "key person" insurance on its executives.

Board Composition: The Board of Directors has delegated to the audit committee the responsibility for oversight and monitoring of risk assessment, risk management, and risk mitigation policies and programs, including matters related to privacy, information technology, and cybersecurity. Dr. Ryan Saadi beneficially owns approximately 70% of the outstanding shares of Common Stock, making the company a "controlled company" under Nasdaq rules. While the company is not currently taking advantage of the exemptions available to controlled companies (e.g., majority independent board, independent compensation/nominating committees), it maintains the option to do so in the future.

Human Capital Strategy

Workforce Composition (as of March 21, 2025):

• Total Employees: 18 full-time employees.
• Geographic Distribution: Not explicitly detailed, but facilities are in Warren, New Jersey, and Philadelphia, Pennsylvania.
• Skill Mix: Not explicitly detailed, but the company emphasizes attracting and retaining qualified scientific, clinical, and management personnel.

Talent Management: Acquisition & Retention: The company values a work culture that encourages unique and diverse perspectives, optimism, creativity, and a commitment to developing accessible immunotherapies. Its "CORE" values are Curiosity, Optimism, Respect, and Equality. Talent recruitment focuses on evaluating job applicants based on these values and passions, in addition to experience. Diversity & Development:

• Development Programs: As the company grows, it plans to create more defined programs to enhance company culture and personnel retention.
• Culture & Engagement: The company's culture is centered around its four CORE values, aiming to foster a collaborative environment.

Regulatory Environment & Compliance

Regulatory Framework: Industry-Specific Regulations: Tevogen Bio Holdings Inc.'s biological products are subject to extensive and rigorous regulation by the FDA under the Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA). This includes requirements for preclinical studies (GLP), Investigational New Drug (IND) applications, Institutional Review Board (IRB) approvals, human clinical trials (GCP), Biologics License Applications (BLA), manufacturing compliance (cGMP, GTP), user fees (PDUFA), and post-approval requirements (e.g., Risk Evaluation and Mitigation Strategies (REMS), adverse event reporting, post-approval studies). The company plans to seek Regenerative Medicine Advanced Therapy (RMAT) designation for some therapies to potentially expedite development and review. International Compliance: The company intends to seek approval to market its product candidates in selected foreign jurisdictions, which will subject it to equivalent foreign regulatory frameworks.

Trade & Export Controls:

• Export Restrictions: The distribution of prescription drugs and biologics is subject to the Drug Supply Chain Security Act (DSCSA), requiring compliance with product identification, tracing, verification, and licensing. The Prescription Drug Marketing Act and state laws also limit the distribution of pharmaceutical samples.
• Sanctions Compliance: Not explicitly detailed, but compliance with trade restrictions and sanctions is implied by the nature of global commercialization.

Legal Proceedings: Tevogen Bio Holdings Inc. is not currently a party to any material pending legal proceedings.

Tax Strategy & Considerations

Tax Profile (as of December 31, 2024):

• Effective Tax Rate: 0% for 2024 and 2023, due to net losses and the establishment of a full valuation allowance against net deferred tax assets.
• Net Operating Loss (NOL) Carryforwards:
  • Federal: Approximately $25.6 million, with an indefinite life, subject to an 80% limitation on taxable income for NOLs generated after 2017.
  • State: Approximately $27.8 million, which begin expiring in 2040.
• Valuation Allowance: A full valuation allowance of $16.6 million was applied against net deferred tax assets, as management believes it is more likely than not that future taxable income will not be sufficient to realize these assets.

Geographic Tax Planning: Not explicitly detailed in the filing.

Tax Reform Impact: The company acknowledges that legislative and regulatory changes in healthcare, such as the Affordable Care Act (ACA) and the Inflation Reduction Act (IRA), could impact the drug approval process and pricing, potentially affecting market conditions for its product candidates.

Insurance & Risk Transfer

Risk Management Framework: Tevogen Bio Holdings Inc. faces an inherent risk of product liability exposure from testing product candidates in human trials and from potential commercialization.

• Insurance Coverage: The company currently holds liability insurance coverage consistent with industry standards. It intends to expand its insurance coverage to include the sale of commercial products if marketing approval is obtained for its product candidates.
• Risk Transfer Mechanisms: Not explicitly detailed beyond product liability insurance.