Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (August 2020)

23 slides from Tonix Pharmaceuticals's investor presentation, Aug 17, 2020

  1. Slide 1: COVID-19 Vaccines: Challenges and Opportunities

    © 2020 Tonix Pharmaceuticals Holding Corp. 1 August 2020 NASDAQ: TNXP Version P0240 (Doc 0691) COVID - 19 Vaccines: Challenges and Opportunities

  2. Slide 2: Cautionary Note on Forward-Looking Statements

    © 2020 Tonix Pharmaceuticals Holding Corp. 2 Cautionary Note on Forward - Looking Statements Certain statements in this presentation regarding strategic plans, expectations and objectives for future operations or results are “forward - looking statements” as defined by the Private Securities Litigat

  3. Slide 3: Seth Lederman, MD

    © 2020 Tonix Pharmaceuticals Holding Corp. 3 Seth Lederman, MD Currently, CEO of Tonix Pharmaceuticals, Dr. Lederman began his career in research in the early days of the AIDS crisis and studied the entry of HIV into cells at the molecular and cell biological levels. Dr. Lederman is a co - inventor

  4. Slide 4: What Is the Goal of Vaccination?

    © 2020 Tonix Pharmaceuticals Holding Corp. 4 What Is the Goal of Vaccination? • Vaccination instructs the immune system how to respond rapidly upon reinfection 1 - 3 • A typical infection is a race between the virus and the immune response • Vaccination gives the body a “head start” • Most vaccines

  5. Slide 5: Immune Memory

    © 2020 Tonix Pharmaceuticals Holding Corp. 5 Immune Memory • Recognizes the offending pathogen or toxin • T cells recognize fragments of pathogens on the surfaces of infected cells • Antibodies recognize the pathogens directly • Recalls the type of immune response elicited • For better: Protective r

  6. Slide 6: The Roles of Antibodies and Cellular Immunity in Vaccines

    © 2020 Tonix Pharmaceuticals Holding Corp. 6 The Roles of Antibodies and Cellular Immunity in Vaccines • Antibody immunity • Recognizes pathogens directly • Antibodies can prevent infection (in lab experiments) • Typical clinical test for exposure to a virus • T cell immunity • Recognizes fragments

  7. Slide 7: Scale: T cells are Much Larger than Antibodies and Viruses

    © 2020 Tonix Pharmaceuticals Holding Corp. 7 Scale: T cells are Much Larger than Antibodies and Viruses Antibodies CD8 T cell Infected host cell CD8 T cell Reduced in size Magnified in size Antibodies Infected host cell Virus

  8. Slide 8: Contrasting T cell and Antibody Immunity

    © 2020 Tonix Pharmaceuticals Holding Corp. 8 Contrasting T cell and Antibody Immunity • T cell immunity • Durable or long - lived (many years) • Recognize fragments of pathogens on the surfaces of infected cells • Cannot recognize pathogens directly • Potential to clear viral infections (by killing

  9. Slide 9: Distinct, Non-Overlapping Roles for T cells and Antibodies in Viral Immunity

    © 2020 Tonix Pharmaceuticals Holding Corp. 9 Distinct, Non - Overlapping Roles for T cells and Antibodies in Viral Immunity Antigens Recognized Effector Functions Infected cells Viruses directly Kill infected cells Block entry T cells + - + - Antibodies - + - + 1 Intracellular pathogens include intr

  10. Slide 10: Unique Challenges of SARS-CoV-2

    © 2020 Tonix Pharmaceuticals Holding Corp. 10 Unique Challenges of SARS - CoV - 2 SARS - CoV - 2 is more infectious, has a longer incubation time, and presents asymptomatically in more individuals, making it highly spreadable 1 The death rate for COVID - 19 is significantly lower compared to SARS. 1

  11. Slide 11: COVID-19: Reason for Optimism?

    © 2020 Tonix Pharmaceuticals Holding Corp. 11 COVID - 19: Reason for Optimism? • Most people recover, which suggests: • Vaccines can be designed that safely mimic infection • Herd immunity can be achieved by vaccination • Vaccine developers can learn from individuals who recover • Study their immuni

  12. Slide 12: Successful Vaccines Recapitulate Optimal Immune Responses to Infection

    © 2020 Tonix Pharmaceuticals Holding Corp. 12 Humoral Immunity (T H 2) Inactive CD8 T cell DC Memory CD4 T cell Memory CD8 T cell CD8 T cell Cellular Immunity (T H 1) Memory B cell Antibodies CD4 T cell B cell IFNs IL - 4 Vaccine Inactive CD4 T cell Successful Vaccines Recapitulate Optimal Immune Re

  13. Slide 13: Humoral Immunity May Only Be Protective Against SARS-CoV for a Limited Duration

    © 2020 Tonix Pharmaceuticals Holding Corp. 13 Humoral Immunity May Only Be Protective Against SARS - CoV for a Limited Duration • High levels of virus - specific antibodies are found in recovered SARS patients, though these decline rapidly 1 - 3 • Virus - specific memory B - cell responses are undet

  14. Slide 14: Over-Active Humoral Immunity May Be Damaging in SARS-CoV Infection

    © 2020 Tonix Pharmaceuticals Holding Corp. 14 100 Over - Active Humoral Immunity May Be Damaging in SARS - CoV Infection • Patients with early, strong humoral responses against SARS - CoV had worse outcomes, with disease severity correlated to T H 2 cytokine patterns 1 - 3 • Over - active antibody r

  15. Slide 15: Live, Replicating Virus Vaccines for Other Infectious Diseases

    © 2020 Tonix Pharmaceuticals Holding Corp. 15 Live, Replicating Virus Vaccines for Other Infectious Diseases 1 • Long term, durable immunity • Stimulate T cells and provide years to decades of protection • Single administration, scalable manufacturing • Low dose is amplified by replication, mRNA and

  16. Slide 16: Live Replicating Vaccines Induce T Helper (TH1) Polarization of Immunity

    © 2020 Tonix Pharmaceuticals Holding Corp. 16 Live Replicating Vaccines Induce T Helper 1 (T H 1) Polarization of Immunity Initial exposure to a vaccine or pathogen pushes immunity towards one of two mutually exclusive responses 1 • T H 1 is T cell predominant – “cell mediated immunity” • Effective

  17. Slide 17: TH Polarization is Typically Effective Against Viruses

    © 2020 Tonix Pharmaceuticals Holding Corp. 17 T H 1 Polarization is Typically Effective Against Viruses FDA’s guidance on COVID - 19 vaccines recognizes T H 1 responses 1 • T H 1 inducing vaccines may go to First - in - Human studies without certain animal testing An inappropriate T H 2 immune respo

  18. Slide 18: Types of Pathogen and Effective Immune Responses

    © 2020 Tonix Pharmaceuticals Holding Corp. 18 Types of Pathogen and Effective Immune Responses Type of Pathogen Intra - cellular (Viruses 1 ) Extra - cellular (Bacteria 2 ) T - Helper Polarization Predominant Immunity T H 1 T cells + - T H 2 Antibodies - + 1 Intracellular pathogens include intracell

  19. Slide 19: Vaccine Type and Expected Immunity

    © 2020 Tonix Pharmaceuticals Holding Corp. 19 Vaccine Type and Expected Immunity Type of Vaccine Subunit DNA/RNA Non - Replicating Live Replicating Probability of Expected Polarization T H 1 Unlikely Unknown Unknown Likely T H 2 Likely Unknown Unknown Unlikely DNA/RNA vaccines and non - replicating

  20. Slide 20: COVID-19 Vaccine Landscape

    © 2020 Tonix Pharmaceuticals Holding Corp. 20 COVID - 19 Vaccine Landscape • We expect more than one vaccine will be approved by FDA • Different vaccines for different individuals • More than 150 vaccines in development • Diversity of approaches is important since protective immunity is not yet unde

  21. Slide 21: Where Do We Go From Here?

    © 2020 Tonix Pharmaceuticals Holding Corp. 21 Where Do We Go From Here? • Goal: Effective COVID - 19 vaccines • So we can return to work and school • Need #1 Quickly available vaccines • Even if they offer only temporary immunity -- several now in human trials • Need #2 Vaccines providing long - ter

  22. Slide 22: TNX-1800: COVID-19 Vaccine Engineered for Long-term Immunity

    © 2020 Tonix Pharmaceuticals Holding Corp. 22 TNX - 1800 1 : COVID - 19 Vaccine Engineered for Long - term Immunity • Based on viral vaccine developed more than 200 years ago by Edward Jenner for a smallpox vaccine • Eradicated smallpox • T cell eliciting immunity • Single dose immunity without adju

  23. Slide 23: Thank You!

    © 2020 Tonix Pharmaceuticals Holding Corp. 23 Thank You!

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