Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (August 2021)

32 slides from Tonix Pharmaceuticals's investor presentation, Aug 27, 2021

  1. Slide 1: August 2021 Investor Presentation

    © 2021 Tonix Pharmaceuticals Holding Corp. 1 August 2021 Investor Presentation NASDAQ:TNXP Version P0315 8 - 27 - 2021 (Doc 0888)

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

    © 2021 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: Tonix Pharmaceuticals: Who We Are and What We Do

    © 2021 Tonix Pharmaceuticals Holding Corp. 3 Tonix Pharmaceuticals: Who We Are and What We Do Mission And Purpose Clinical - stage biopharmaceutical company that invents, licenses, acquires and develops innovative medicines to help patients manage central nervous system (CNS) and immunology conditio

  4. Slide 4: Tonix Pipeline – CNS, Immunology and Biodefense Portfolio

    © 2021 Tonix Pharmaceuticals Holding Corp. 4 Tonix Pipeline – CNS, Immunology and Biodefense Portfolio CANDIDATES INDICATION STATUS Central Nervous System (CNS) TNX - 102 SL 1 Fibromyalgia (FM) Posttraumatic Stress Disorder (PTSD) Long COVID (PASC 2 ) Mid - Phase 3 – ongoing Phase 2 Clinical – pre -

  5. Slide 5: Tonix Pipeline – COVID-19 Portfolio

    © 2021 Tonix Pharmaceuticals Holding Corp. 5 Tonix Pipeline – COVID - 19 Portfolio CANDIDATES INDICATION STATUS COVID - 19 Portfolio TNX - 1800 COVID - 19 vaccine 1 Phase 1, 1H 2022* TNX - 2300 COVID - 19 vaccine 2 Preclinical TNX - 102 SL Long COVID (PASC 3 ) Clinical – pre - IND 4 TNX - 2100 SARS

  6. Slide 6: COVID Vaccines with FDA Approval or EUA: Still Uncertainty

    © 2021 Tonix Pharmaceuticals Holding Corp. 6 COVID - 19 Vaccines with FDA Approval or Emergency Use Authorization (EUA): Still Uncertainty Durability of protection • Vaccinated people lose protection, starting at 6 months 1 • Increasing rates of “breakthrough” COVID • White House advocating booster

  7. Slide 7: COVID Vaccines: Where do we go from here?

    © 2021 Tonix Pharmaceuticals Holding Corp. 7 COVID - 19 Vaccines: Where do we go from here? mRNA vaccines have given us some time, but are unlikely to be a long - term solution • Vaccinated people lost protection, increasing rates of “breakthrough” COVID • COVID is becoming endemic; vaccination of e

  8. Slide 8: TNX-1800: a Live Virus COVID Vaccine Candidate

    © 2021 Tonix Pharmaceuticals Holding Corp. 8 TNX - 1800 1 : a Live Virus COVID - 19 Vaccine Candidate • Utilizes Tonix’s proprietary horsepox virus as a vector • Encodes a protein from SARS - CoV - 2, the cause of COVID - 19 • Developed in collaboration with University of Alberta, Canada • Animal te

  9. Slide 9: Vaccinia Induces a Skin Reaction Called “Take”

    © 2021 Tonix Pharmaceuticals Holding Corp. 9 Vaccinia Induces a Skin Reaction Called “Take” – Described by Dr. Edward Jenner 1. Fulginiti VA, et al. Clin Infect Dis. 2003;37(2):241 - 250. 2. Liu L, et al. Nature Med. 2010;16(2):224 - 228. 3. Centers for Disease Control and Prevention. Accessed April

  10. Slide 10: Potential Profile of TNX-1800 Compared to mRNA COVID-19 Vaccines

    © 2021 Tonix Pharmaceuticals Holding Corp. 10 Potential Profile of TNX - 1800 Compared to mRNA COVID - 19 Vaccines Criteria mRNA Vaccines TNX - 1800 Number of shots Two One Duration 8 months Years / decades Boosters Recommended Not required Protection from variants Variable Expected Forward Transmis

  11. Slide 11: COVID Vaccine Platform: Planned Internal Development and Manufacturing Capabilities

    © 2021 Tonix Pharmaceuticals Holding Corp. 11 COVID - 19 Vaccine Platform: Planned Internal Development and Manufacturing Capabilities Infectious Disease R&D Center (RDC) – Frederick, MD • Function : Accelerated development of vaccines and antiviral drugs against COVID - 19, its variants and other i

  12. Slide 12: Infectious Disease R&D Facility

    © 2021 Tonix Pharmaceuticals Holding Corp. 12 Infectious Disease R&D Facility Expect to close on acquisition from Southern Research October 1, 2021 Located in Frederick, MD

  13. Slide 13: Advanced Development Center Renderings

    © 2021 Tonix Pharmaceuticals Holding Corp. 13 Advanced Development Center Renderings • Groundbreaking August 2021 • Expect to be operational 1H22 • Located in New Bedford, MA

  14. Slide 14: US COVID Vaccine Booster Developments

    © 2021 Tonix Pharmaceuticals Holding Corp. 14 US COVID - 19 Vaccine Booster Developments Current US Government recommendation is boosters at EIGHT months post - Pfizer or Moderna vaccination 1 • CDC, FDA, White House, COVID - 19 Response Team believe immunity wanes by 8 months – vaccines will be ava

  15. Slide 15: Assessing Anti-SARS-CoV-2 Protective Immunity

    © 2021 Tonix Pharmaceuticals Holding Corp. 15 Assessing anti - SARS - CoV - 2 Protective Immunity Two types of immunity • Antibodies – can be measured in a blood test, but anti - SARS - CoV - 2 antibodies are not predictive of protection • T cell – can be measured in a blood test, but requires sophi

  16. Slide 16: TNX-2100: Potential Skin Test to Measure SARS-CoV-2 Exposure and T Cell Immunity

    © 2021 Tonix Pharmaceuticals Holding Corp. 16 TNX - 2100 1 : Potential Skin Test to Measure SARS - CoV - 2 Exposure and T Cell Immunity TNX - 2100 (SARS - CoV - 2 epitope peptide mixtures for intradermal administration) • Designed to elicit delayed - type hypersensitivity (DTH) in individuals who ha

  17. Slide 17: Anti-COVID Therapeutics

    © 2021 Tonix Pharmaceuticals Holding Corp. 17 Anti - COVID - 19 Therapeutics The only antiviral that is FDA approved is Remdesivir/ Veklury ® from Gilead • Intravenous ( i.v. ) medicine • Approved for patients who are at least 12 years old and require hospitalization • May shorten the time to recove

  18. Slide 18: TNX-3500: SARS-CoV-2 Antiviral for the Treatment of COVID-19

    © 2021 Tonix Pharmaceuticals Holding Corp. 18 TNX - 3500 1 : SARS - CoV - 2 Antiviral for the Treatment of COVID - 19 TNX - 3500 (sangivamycin) – potential monotherapy antiviral 2 • Licensed from OyaGen , April 2021 • Demonstrated broad spectrum antiviral activity (nanomolar activity against SARS -

  19. Slide 19: TNX-102 SL for Fibromyalgia: Current Status

    © 2021 Tonix Pharmaceuticals Holding Corp. 19 TNX - 102 SL for Fibromyalgia: Current Status 2 nd Phase 3 study, RALLY (F306) • July 2021: Tonix stopped enrollment in the RALLY study following an unblinded, pre - planned interim analysis by the Independent Data Monitoring Committee (IDMC) • Based on

  20. Slide 20: Long COVID (PASC)

    © 2021 Tonix Pharmaceuticals Holding Corp. 20 Long COVID (PASC) Officially known as “Post - acute Sequelae of COVID - 19” (PASC) 1 • Symptoms can include fatigue, sleep disorders, pain, fevers, shortness of breath, cognitive impairment described as “brain fog”, gastrointestinal symptoms, anxiety, an

  21. Slide 21: TNX-102 SL for Long COVID (PASC)

    © 2021 Tonix Pharmaceuticals Holding Corp. 21 TNX - 102 SL for Long COVID (PASC) Long COVID Overlap with Fibromyalgia • Long COVID has been compared to fibromyalgia because of the common symptoms of sleep disturbance, persistent pain, fatigue, and brain fog 1 • Fibromyalgia - like syndrome observed

  22. Slide 22: TNX-102 SL for Other Indications

    © 2021 Tonix Pharmaceuticals Holding Corp. 22 TNX - 102 SL for Other Indications Beyond Long COVID and Fibromyalgia, TNX - 102 SL is under development for multiple indications • PTSD – active IND ‒ Planning Kenya Police Phase 2 study ‒ Phase 2 and two Phase 3 studies missed primary endpoint but show

  23. Slide 23: TNX-1300: Cocaine Antidote

    © 2021 Tonix Pharmaceuticals Holding Corp. 23 TNX - 1300: Cocaine Antidote Positive Phase 2 in volunteers in lab setting - FDA Breakthrough Designation • TNX - 1300 decreased physiological effects of cocaine 1 CocE or cocaine esterase rapidly disintegrates cocaine • Natural bacterial CocE is unstabl

  24. Slide 24: TNX-1900 (Intranasal Potentiated Oxytocin) for the Treatment of Migraine

    © 2021 Tonix Pharmaceuticals Holding Corp. 24 TNX - 1900 (Intranasal Potentiated Oxytocin) for the Treatment of Migraine Intranasal oxytocin(OT) has potential utility in treating migraine 1 • Intranasal ( i.n. ) OT reaches the trigeminal ganglion • Preclinical evidence of OT blocking CGRP release an

  25. Slide 25: TNX-2900 for the Treatment of Prader-Willi Syndrome

    © 2021 Tonix Pharmaceuticals Holding Corp. 25 TNX - 2900 ( i.n. Potentiated OT) for the Treatment of Prader - Willi Syndrome Prader - Willi syndrome is the most common genetic cause of life - threatening childhood obesity 1 • Results in lack of suckling in infants and, in children and adults, severe

  26. Slide 26: TNX-601 CR for Major Depressive Disorder

    © 2021 Tonix Pharmaceuticals Holding Corp. 26 TNX - 601 CR* (Tianeptine Oxalate and Naloxone HCl Controlled Release) Tablets for the Treatment of Major Depressive Disorder (MDD) Proprietary new controlled release formulation for once - daily dosing • Pending toxicology results, and IND clearance, Ph

  27. Slide 27: TNX-601 CR: A Potential Treatment for Depression

    © 2021 Tonix Pharmaceuticals Holding Corp. 27 TNX - 601 CR : A Potential Treatment for Depression TNX - 601 CR’s proposed mechanism of action is completely distinct from any approved antidepressant in the U.S. • Antidepressant activity is believed to relate to indirect modulation of the glutamatergi

  28. Slide 28: TNX-1500, a New CD40L Antibody, for Prevention of Allograft Rejection

    © 2021 Tonix Pharmaceuticals Holding Corp. 28 TNX 1500, a New CD40 Ligand (CD40L) Antibody, for the Prevention of Allograft Rejection The CD40 - CD40L pathway is a pivotal immune system modulator and is a well - established and very promising treatment target to more safely prevent allograft rejecti

  29. Slide 29: Tonix Pipeline: Selected Programs

    © 2021 Tonix Pharmaceuticals Holding Corp. 29 Tonix Pipeline: Selected Programs COVID - 19 Programs • Prevention: TNX - 1800 vaccine – Phase 1 study expected 1H2022 • Treatment of acute COVID - 19: TNX - 3500 antiviral – pre - clinical • Diagnostic indicator of protective immunity: TNX - 2100 skin t

  30. Slide 30: Milestones – Recently Completed and Upcoming

    © 2021 Tonix Pharmaceuticals Holding Corp. 30 Milestones – Recently Completed and Upcoming 1 □ 4 th Quarter 2020 Positive topline data from TNX - 102 SL Phase 3 F304/RELIEF study in fibromyalgia reported □ 1 st Quarter 2021 Non - human primate positive efficacy data from TNX - 1800 in COVID - 19 mod

  31. Slide 31: Management Team

    © 2021 Tonix Pharmaceuticals Holding Corp. 31 Management Team Seth Lederman, MD President & CEO Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger , CPA Chief Financial Officer

  32. Slide 32: Thank You!

    © 2021 Tonix Pharmaceuticals Holding Corp. 32 Thank You!

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