Tevogen Bio Holdings Inc. · NASDAQ:TVGN
Tevogen Bio — Investor Presentation (June 2025)
34 slides from Tevogen Bio's investor presentation, June 2025
Slide 1: Corporate Overview | June 2025
A healthier world is possible when lifesaving innovations are within the reach of all ẅẅẅ CORPORATE OVERVIEW | June 2025
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains certain forward-looking statements, including without limitation statements relating to: expectations regarding the healthcare and biopharmaceutical industries; Tevogen’s development of, the potential benefits of, and patient access to its produc
Slide 3: Executive Summary
Executive Summary
Slide 4: Executive Summary
Executive Summary EXACTCELLTM TECHNOLOGY Proprietary technology with broad applications for convenient and affordable cellular immunotherapies with Tevogen Bio is a clinical-stage specialty disease target specificity; highly enriched, scalable, genetically unmodified allogeneic T cells for the treat
Slide 5: Key Achievements
Key Achievements Tevogen moved its first product from discovery to clinical phase within 18 months of inception REGULATORY Mar 2021 May 2021 TVGN 489 Ambulatory acute-risk SARS-CoV-2 pre-clinical treatment IND cleared by FDA completed (TVGN 489) Apr 2021 Oct 2021 Jan 2023 Jun 2024 CLINICAL TVGN 489
Slide 6: Planned Priorities
Planned Priorities Reflects management’s current assumptions, estimates, projections and beliefs SHORT TERM MID TERM • Expand R&D and clinical manufacturing capacity • Expand manufacturing capacity to match the forecasted demand • TVGN 489 pivotal trial for treatment of SARS-CoV-2 infection • Prepar
Slide 7: Our Science and ExacTcell Technology
Our Science and ExacTcell Technology TM • Naturally occurring T cells enriched and expanded for precision targeting restricted by a single HLA molecule • A unique approach focused on administering allogeneic, personalized, and economically sustainable T cell therapeutics
Slide 8: ExacTcell - Mechanism of Action
ExacTcell - Mechanism of Action
Slide 9: ExacTcell - Manufacturing Like Nature
ExacTcell - Manufacturing Like Nature
Slide 10: ExacTcell – Mode of Action
ExacTcell – Mode of Action Focuses on the selection and expansion of naturally occurring, genetically unmodified T cells to target multiple, distinct, preselected proteins present only on virus-infected or malignant cells and to kill those cells. VIEW ANIMATION ON Human Leukocyte Antigens (HLA) show
Slide 11: ExacTcell – Tevogen's T Cell Therapy
ExacTcell – Tevogen's T Cell Therapy Tevogen’s commercial scale ready manufacturing process yields a highly efficient ratio of doses per cell donor VIEW ANIMATION ON T cells donated by T cells exposed to T cells that naturally The selected T cells After infusion T cells a single donor. artificially
Slide 12: ExacTcell – Benefits and Uniqueness
ExacTcell – Benefits and Uniqueness A technology that enables potentially safe, effective, and easy to administer cell therapy Tumor Infiltrating Bispecific T cell ExacTcell Autologous CAR-T Allogeneic CAR-T Lymphocytes (TILs) Engager (BiTE®) Designed to attack only diseased cells and spare normal h
Slide 13: Advantages of Using TVGN 489 to Treat Cancer Patients with SARS-CoV-2
Advantages of Using TVGN 489 to Treat Cancer Patients with SARS-CoV-2 Avoiding prolonged gaps in cancer treatment increases chances of cancer treatment success • Cancer is typically treated in repetitive fashion. The time interval between cancer treatments allow the body to recover more so than the
Slide 14: Pipeline & Strategy
Pipeline & Strategy • Tevogen Bio is developing therapeutic products that not only treat cancer but also enable oncology patients to maintain uninterrupted therapy. • Addition of non-oncology products to the pipeline is an opportunistic approach to maximize ROI from our proprietary ExacTcell technol
Slide 15: Pipeline – Oncology
Pipeline – Oncology Oncology Discovery / Preclinical Phase 1 / Safety Data Available1 Phase 2/3 (Potentially Pivotal2) Incidence / Prevalence TVGN 489 Tx: SARS-CoV-2 infection in patients with B cell hematologic cancer3 ~65,0004 / 750,0005 B cell NHL ~715,000 / 2.175 million TVGN 489 Tx: SARS-CoV-2
Slide 16: Pipeline – Rheumatology / Multiple Specialties / Neurology
Pipeline – Rheumatology / Multiple Specialties / Neurology Immune suppressed patients with SARS-CoV-2 infection or patients with late sequalae of viral infections Rheumatology Discovery / Preclinical Phase 1 / Safety Data Available1 Phase 2/3 (Potentially Pivotal2) Prevalence TVGN 489 Tx: SARS-CoV-2
Slide 17: TVGN 489 in Long COVID
TVGN 489 in Long COVID • Recent studies1 have detected persistent Spike and Nucleocapsid proteins in some Long COVID patients suggesting the existence of a viral reservoir in these patients. • None of the patients treated with TVGN 489 developed Long COVID during the 6-month study follow up period2.
Slide 18: Leadership & Board
Leadership & Board
Slide 19: Key Executive Leadership
Key Executive Leadership Leadership with diversified experience across all sectors of the healthcare ecosystem and a successful track Neal Flomenberg, MD record in drug development Ryan Saadi, MD, MPH Chief Scientific Officer and Chief Executive Officer Global R&D Lead Yale University Thomas Jeffers
Slide 20: Board of Directors
Board of Directors Curtis Patton, PhD Susan Podlogar, MBA Ryan Saadi, MD, MPH Board of Directors Board of Directors Chair, Board of Directors Professor Emeritus of Former: CHRO MetLife, J&J, Leadership Council Yale SPH Epidemiology, Yale SPH Bayer, BMS Jeffrey Feike, MPH Victor Sordillo Lindee Goh,
Slide 21: Clinical Trial
Clinical Trial Safety and feasibility of third-party cytotoxic T lymphocytes for high-risk patients with COVID-19 | Blood Advances | American Society of Hematology (ashpublications.org)
Slide 22: Clinical Trial – Design and Objectives
Clinical Trial – Design and Objectives DESIGN OBJECTIVES Patient Assignment Primary Endpoints (Interventional Arm) Assignment to the Interventional versus Observational Arm was based on the Assess the safety of TVGN 489 when given at 4 escalating dose levels. Safety subject’s HLA type. Rapid HLA typ
Slide 23: Clinical Trial – Target & Size of Population
Clinical Trial – Target & Size of Population Dose-finding study with four dosing levels of SARS-CoV-2-Specific Cytotoxic T Lymphocytes (TVGN 489) TARGET POPULATION Ambulatory patients with newly diagnosed SARS-CoV-2 infection at acute risk for complications due to one or more of the following condit
Slide 24: Clinical Trial – Patient Characteristics
Clinical Trial – Patient Characteristics 50% of patients in the Interventional Arm were on active cancer or lupus treatment Patient Interventional Observational Vaccination Dosing Level Ethnicity / Age Comorbidities Variant Arm Arm Status Gender Median Age 59 57 African Amer (Range) (24 – 83) (26 –
Slide 25: Clinical Trial – Key Observations
Clinical Trial – Key Observations Therapy well-tolerated at all dose levels, no dose limiting toxicities observed PRIMARY ENDPOINT EXPLORATORY ENDPOINT 25 Dose-Limiting Toxicity Criteria Trial Result 20 ≥ Grade 3 acute infusion reaction None Day Felt Better 15 Cytokine release syndrome (Hypoxia and/
Slide 26: Clinical Trial – Key Observations
Clinical Trial – Key Observations Rapid viral load reduction after TVGN 489 treatment; documented persistence of TVGN 489 SECONDARY ENDPOINTS Time to Eliminate 99-100% of Viral Load Persistence of CTLs Patient Day 0 Day 4 Day 7 Day 10 Day 14 1 2 0.02% 3 Frequency of Product Clones SARS-CoV-2 viral p
Slide 27: ExacTcell – Ongoing Efficacy Against SARS-CoV-2 Strains
ExacTcell – Ongoing Efficacy Against SARS-CoV-2 Strains as of Sep 2024 Tevogen’s targets have been preserved throughout the pandemic; vaccines and mAbs target the quickly mutating Spike protein, leading to a potential sudden loss or reduction in efficacy Percentage of Isolates with Preserved Spike T
Slide 28: Artificial Intelligence
TEVOGEN Artificial Intelligence
Slide 29: Enhancing Patient Access by Utilizing Artificial Intelligence-powered Tools
Enhancing Patient Access by Utilizing Artificial Intelligence-powered Tools Target Detection: We are exploring ways to deploy Tevogen.AI continues to build a data pipeline and AI-powered target detection to further accelerate our Tevogen.AI will leverage Microsoft’s digital curate data across numero
Slide 30: Thank You
Thank You Please contact us with investor inquiries at: ir@tevogen.com For all other inquiries: info@tevogen.com 1 877-TEVOGEN
Slide 31: Appendix
Appendix Slide 10 TIL Therapy 1. Tumor-Infiltrating Lymphocyte (TIL) Therapy | Dana-Farber Cancer Institute 2. TIL Therapy | Treatment for Melanoma | OHSU Knight Cancer 3. NIH cost of TIL therapy, in First Cancer TIL Therapy Gets FDA Approval for Advanced Melanoma, Lifileucel First Cellular Therapy
Slide 32: Appendix
Appendix Slide 13 1. Phase 1 clinical trials are designed in part to generate proof of concept data and safety-related data on tolerability and side effects. 2. A pivotal trial is a trial designed to generate data sufficient to support the filing of an application for regulatory approval. A pivotal
Slide 33: Appendix
Appendix Slide 13 9. Top lymphomas associated with EBV are1: Annual Incidence: Prevalence: 1. Burkitt Lymphoma (Sporadic) (Incidence of EBV association is 10%) 1,2003 x 10% = 120 <5,0004 x 10% = 500 2. Classical Hodgkin Lymphoma (Incidence of EBV association is 31%) 8,5705 x 31% = 2,657 228,0815 x 3
Slide 34: Appendix
Appendix Slide 14 1. Phase 1 clinical trials are designed in part to generate proof of concept data and safety-related data on tolerability and side effects. 2. A pivotal trial is a trial designed to generate data sufficient to support the filing of an application for regulatory approval. A pivotal
Tevogen Bio Holdings — Investor Presentation (June 2025) on 6ix