Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (November 2020)

45 slides from Tonix Pharmaceuticals's investor presentation, Nov 10, 2020

  1. Slide 1: Investor Presentation

    © 2020 Tonix Pharmaceuticals Holding Corp. 1 November 2020 Version P0253 11 - 10 - 20 (Doc 0726) Investor Presentation NASDAQ:TNXP

  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: Tonix Pharmaceuticals

    © 2020 Tonix Pharmaceuticals Holding Corp. 3 Tonix Pharmaceuticals © 2020 Tonix Pharmaceuticals Holding Corp . • Clinical - stage biopharmaceutical company • Committed to discovering and developing innovative and proprietary new therapeutics • Focus on developing biologics and small molecules • Immu

  4. Slide 4: Our Pipeline – Immunology & Biodefense Portfolio

    © 2020 Tonix Pharmaceuticals Holding Corp. 4 Our Pipeline – Immunology & Biodefense Portfolio CANDIDATES INDICATION STATUS Immunology Portfolio TNX - 1800 Covid - 19 vaccine – Prioritized Program 1 Preclinical TNX - 1810, TNX - 1820, TNX - 1830 Covid - 19 vaccine 1 Preclinical TNX - 2300 Covid - 19

  5. Slide 5: Our Pipeline – CNS Portfolio

    © 2020 Tonix Pharmaceuticals Holding Corp. 5 Our Pipeline – CNS Portfolio 1 TNX - 102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication. 2 TNX - 1300 (T172R/G173Q double - mutant cocaine esterase 200 mg, i.v. solution) is an inves

  6. Slide 6: COVID-Vaccine Landscape

    © 2020 Tonix Pharmaceuticals Holding Corp. 6 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 under

  7. Slide 7: Live, Attenuated Virus Vaccines for Other Infectious Diseases

    © 2020 Tonix Pharmaceuticals Holding Corp. 7 Live, Attenuated Virus Vaccines for Other Infectious Diseases 1 • Long term, durable immunity • Expected to stimulate T cells and provide years to decades of protection • Single administration, scalable manufacturing • Low dose is amplified by replication

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

    © 2020 Tonix Pharmaceuticals Holding Corp. 8 TNX - 1800 1 : a 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 testing with

  9. Slide 9: TNX-1800: Engineered for Long-term Immunity

    © 2020 Tonix Pharmaceuticals Holding Corp. 9 TNX - 1800 1 : Engineered for Long - term Immunity • Based on “vaccinia” vaccine developed more than 200 years ago by Dr. Edward Jenner to prevent smallpox • Eradicated smallpox (only viral disease ever eradicated) • Elicits durable (many decades) T cell

  10. Slide 10: Why Use a Horsepox Platform for a Vaccine?

    © 2020 Tonix Pharmaceuticals Holding Corp. 10 Why Use a Horsepox Platform for a Vaccine? Horsepox can be engineered to express foreign genes • Lack of persistence or genomic integration in the host • Strong immunogenicity as a vaccine • Readily manufacture at scale • Live, attenuated vaccine – direc

  11. Slide 11: TNX-1800 is Based on a Horsepox Virus Vector

    © 2020 Tonix Pharmaceuticals Holding Corp. 11 TNX - 1800 is Based on a Horsepox Virus (HPXV) Vector Designed to Express SARS - CoV - 2 S Protein *TNX - 1800 is at the pre - IND stage of development Horsepox sHPXV ~200,000 Bp TNX - 1800 * rHPXV/SARS - CoV - 2S ~200,000 Bp Homologous Recombination

  12. Slide 12: Vaccinia Induces a Skin Reaction Called "Take"

    © 2020 Tonix Pharmaceuticals Holding Corp. 12 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 Apri

  13. Slide 13: Unique Challenges of SARS-CoV-2

    © 2020 Tonix Pharmaceuticals Holding Corp. 13 Unique Challenges of SARS - CoV - 2 SARS Rate of death 1,2 Deaths 2 Rate of infectivity 1 Incubation time 2 Asymptomatic 3 0.4 2 - 7 days ~13% ~10% SARS - CoV - 2 Rate of death 1,4 Deaths (as of Oct. 2020) 5 Rate of infectivity 1,4 Incubation time 2,4 As

  14. Slide 14: Infection of Type II Pneumocytes Can Lead to Lethal Respiratory Illness

    © 2020 Tonix Pharmaceuticals Holding Corp. 14 Infection of Type II Pneumocytes Can Lead to Lethal Respiratory Illness Capillary Type II pneumocytes Inhalation Exhalation Inhalation Exhalation Fluid leakage Activated CD8 T cell Antibodies Type II pneumocytes in the alveoli secrete pulmonary surfactan

  15. Slide 15: SARS-CoV-2 Hijacks the Respiratory System to Spread Contagious Virus

    © 2020 Tonix Pharmaceuticals Holding Corp. 15 SARS - CoV - 2 Hijacks the Respiratory System to Spread Contagious Virus Respiratory epithelium Capillary Airway Resting CD8 T cell Endothelial cell Exhalation spreads virus • Virus factories release virions by continuous budding • Breathing, speaking or

  16. Slide 16: CoV-Specific T Cells Kill the Virus Factories

    © 2020 Tonix Pharmaceuticals Holding Corp. 16 CoV - 2 Specific T Cells Kill the Virus Factories • Natural immunity or vaccine protection has the potential to decrease forward transmission • T cells specifically kill virally infected cells Bar - On YM, et al. eLife . 2020;9:e57309 . Respiratory epith

  17. Slide 17: Contrasting T cell and Antibody Immunity

    © 2020 Tonix Pharmaceuticals Holding Corp. 17 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

  18. Slide 18: TNX-1800 Upcoming Milestones

    © 2020 Tonix Pharmaceuticals Holding Corp. 18 TNX - 1800 Upcoming Milestones Southern Research studies will address two key questions: • Will vaccination of animals elicit an immune response to the S protein? • 4th Quarter 2020 – Non - human primate and small animal response results expected 1 • Wil

  19. Slide 19: COVID-19 Vaccine Platform: Bovine Parainfluenza (BPI) Virus

    © 2020 Tonix Pharmaceuticals Holding Corp. 19 2 nd SARS - CoV - 2 Vaccine Platform: Bovine Parainfluenza (BPI) Virus Collaboration with Kansas State University to develop a vaccine candidate for the prevention of COVID - 19 • Utilizes a novel live attenuated vaccine vector platform and the CD40 - li

  20. Slide 20: Overview of TNX-102 SL Protectic Formulation

    © 2020 Tonix Pharmaceuticals Holding Corp. 20 Overview of TNX - 102 SL* Protectic ® proprietary formulation of cyclobenzaprine that supports sublingual administration Scientific Rationale for Protectic ® Formulation • Engenders unique pharmacokinetic and pharmacodynamic properties that emphasize sle

  21. Slide 21: TNX-102 SL: Differentiation from Oral Formulations

    © 2020 Tonix Pharmaceuticals Holding Corp. 21 TNX - 102 SL: Differentiation from Oral Formulations FEATURE BENEFIT ADVANTAGE Cyclobenzaprine 40+ years as oral medication Established safety record Formulation: Protectic ® Allows submucosal absorption Not achievable with oral formulation Administratio

  22. Slide 22: TNX-102 SL: Results from Completed Fibromyalgia Trials

    © 2020 Tonix Pharmaceuticals Holding Corp. 22 TNX - 102 SL: Results from Completed Fibromyalgia (FM) Trials Completed Trials in FM at 2.8 mg: • Phase 2 (F202 BESTFIT) – 205 patients randomized • Phase 3 (F301 AFFIRM) – 519 patients randomized Topline Efficacy Results: • Studies did not achieve stati

  23. Slide 23: Effect of Dose on Adverse Events at 5.6 mg in PTSD Studies

    © 2020 Tonix Pharmaceuticals Holding Corp. 23 Effect of Dose on Adverse Events (AEs) at 5.6 mg in PTSD Studies # Only adverse events (AEs) are listed that are at a rate of ≥ 5% in any TNX - treated group *No values in a row for either study means the AE in the active group(s) in that study was at a

  24. Slide 24: TNX-102 SL 5.6 mg for Fibromyalgia: Phase 3 F304/RELIEF Study

    © 2020 Tonix Pharmaceuticals Holding Corp. 24 TNX - 102 SL 5.6 mg for Fibromyalgia: Phase 3 F304/RELIEF Study © 2020 Tonix Pharmaceuticals Holding Corp. • Interim Analysis Completed in September 2020 • Independent data monitoring committee (IDMC) made a non - binding recommendation to continue the t

  25. Slide 25: F304/RELIEF Study – Interim Analysis Completed

    © 2020 Tonix Pharmaceuticals Holding Corp. 25 TNX - 102 SL 5.6 mg for Fibromyalgia: Phase 3 F304/RELIEF Study – Interim Analysis Completed Primary e ndpoint (Week 14) : • Daily diary pain severity score change (TNX - 102 SL 5.6 mg vs. placebo) from baseline in the weekly average as measured by the n

  26. Slide 26: F306/RALLY Study – Enrollment Initiated

    © 2020 Tonix Pharmaceuticals Holding Corp. 26 TNX - 102 SL 5.6 mg for Fibromyalgia: Phase 3 F306/RALLY Study – Enrollment Initiated Primary e ndpoint (Week 14) : • Daily diary pain severity score change (TNX - 102 SL 5.6 mg vs. placebo) from baseline in the weekly average as measured by the numerica

  27. Slide 27: TNX-102 SL Intellectual Property – U.S. Protection expected until 2035

    © 2020 Tonix Pharmaceuticals Holding Corp. 27 TNX - 102 SL Intellectual Property – U.S. Protection expected until 2035 • United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent

  28. Slide 28: Approved Fibromyalgia Pharmacotherapies

    © 2020 Tonix Pharmaceuticals Holding Corp. 28 Approved Fibromyalgia Pharmacotherapies Pfizer • Drug: Lyrica® or pregabalin (U.S. patent expired in 2018) • Approved: 2004 • Mechanism: modulates nerve impulses involved in the transmission of pain through selective binding to the alpha2 - delta protein

  29. Slide 29: Other Fibromyalgia Pharmacotherapies in Development in the U.S.

    © 2020 Tonix Pharmaceuticals Holding Corp. 29 Other Fibromyalgia Pharmacotherapies in Development in the U.S. Axsome Therapeutics - AXS - 14 • Drug: esreboxetine • Mechanism: Selective norepinephrine reuptake inhibitor • Developmental Stage: At least mid - Phase 3 (Phase 2 and Phase 3 trial positive

  30. Slide 30: Opportunities to Expand TNX-102 SL to Other Indications

    © 2020 Tonix Pharmaceuticals Holding Corp. 30 Opportunities to Expand TNX - 102 SL to Other Indications Growing recognition that there are many disorders where sleep disturbances may have a role in the pathophysiology (cardiovascular, metabolic, neurologic) • Sleep quality plays a homeostatic role i

  31. Slide 31: TNX-1300 for the Treatment of Cocaine Intoxication

    © 2020 Tonix Pharmaceuticals Holding Corp. 31 TNX - 1300* for the Treatment of Cocaine Intoxication Recombinant protein that degrades cocaine in the bloodstream 1 • Double - mutant cocaine esterase ( CocE ) • CocE was identified in a bacterium ( Rhodococcus ) that use cocaine as its sole source of c

  32. Slide 32: TNX-1300 Is a Fast-acting Cocaine Antidote

    © 2020 Tonix Pharmaceuticals Holding Corp. 32 TNX - 1300 (Cocaine Esterase or CocE ) Is a Fast - acting Cocaine Antidote CocE Rhodococcus bacteria living in the roots of the coca plant use CocE to metabolize cocaine 1 CocE cleaves chemical bonds in cocaine and disintegrates it 800 times faster than

  33. Slide 33: TNX-1300 Development Plan

    © 2020 Tonix Pharmaceuticals Holding Corp. 33 TNX - 1300 Development Plan 33 • Targeting to initiate a Phase 2 open - label, randomized pilot study of TNX - 1300 in the first quarter of 2021 • Emergency department (ED) setting with patients coming in for treatment of cocaine and/or polysubstance int

  34. Slide 34: TNX-1900 for Migraine and Craniofacial Pain – Overview

    © 2020 Tonix Pharmaceuticals Holding Corp. 34 TNX - 1900 for the Treatment of Migraine and Craniofacial Pain – Overview Novel intranasal oxytocin formulation being developed as a prophylactic treatment for chronic migraine • Based on a propriety formulation of oxytocin*, a naturally occurring human

  35. Slide 35: TNX-1900 for the Treatment of Migraine – Prevalence

    © 2020 Tonix Pharmaceuticals Holding Corp. 35 TNX - 1900 for the Treatment of Migraine – Prevalence One billion individuals worldwide suffer from migraines (~14% of population) 1 Migraine is the second leading cause of years lived with disability 1 In U.S., the estimated cost of all migraine headach

  36. Slide 36: TNX-1900 for Migraine – Mechanism of Action

    © 2020 Tonix Pharmaceuticals Holding Corp. 36 TNX - 1900 for the Treatment of Migraine – Mechanism of Action Preclinical research showed that nasally applied TNX - 1900 selectively inhibits the activity of trigeminal pain - sensing nerve cells and blocks the release of CGRP • TNX - 1900 is believed

  37. Slide 37: TNX-1900 Mechanism of Action (continued)

    TNX - 1900 for the Treatment of Migraine – Mechanism of Action (continued) HEAD PAIN PATIENT USES TNX - 1900 TARGETED DELIVERY Permeates nasal mucosa Transported to trigeminal system and brain Proprietary Nasal to Brain Delivery CGRP: NEUROTRANSMITTER THAT HAS BEEN VALIDATED AS KEY MIGRAINE TARGET T

  38. Slide 38: TNX-1900: Mechanism of Action (continued)

    TNX - 1900: Mechanism of Action (continued) In animal models, intranasal oxytocin concentrates in the trigeminal system I nhibits trigeminal neuronal firing, and decreases CGRP (and PACP) release onto meningeal vasculature and within the brainstem - Believed to have effects on: - Neurogenic inflamma

  39. Slide 39: TNX-1900 for Migraine – Development Status

    © 2020 Tonix Pharmaceuticals Holding Corp. 39 TNX - 1900 for the Treatment of Migraine – Development Status In June 2020, Tonix acquired a proprietary formulation of nasal oxytocin solution for intranasal delivery from Trigemina Also acquired migraine and pain treatment technologies of Trigemina , I

  40. Slide 40: Psychiatry, Immunology and Oncology Preclinical Pipeline

    © 2020 Tonix Pharmaceuticals Holding Corp. 40 Psychiatry, Immunology and Oncology Preclinical Pipeline 1 1 Experimental new medicines and biologics, not approved for any indication 2 (2S,4R,5R) - 5 - (((2 - aminobenzo[d]thiazol - 6 - yl)methyl)amino) - 2 - (bis(4 - fluorophenyl)methyl)tetrahydro - 2

  41. Slide 41: Pipeline Summary – by Select Therapeutic Areas

    © 2020 Tonix Pharmaceuticals Holding Corp. 41 Pipeline Summary – by Select Therapeutic Areas Pain Psychiatry Addiction Medicine • TNX - 102 SL (sublingual cyclobenzaprine) for fibromyalgia Phase 3/RELIEF Phase 3/RALLY • TNX - 102 SL (sublingual cyclobenzaprine) for PTSD Phase 3/RECOVERY • TNX - 102

  42. Slide 42: Pipeline Summary – by Select Therapeutic Areas (continued)

    © 2020 Tonix Pharmaceuticals Holding Corp. 42 Pipeline Summary – by Select Therapeutic Areas (continued) Biodefense • TNX - 801 (live horsepox vaccine) for preventing smallpox and monkeypox Preclinical • TNX - 1200 (live vaccinia vaccine) for preventing smallpox and monkeypox Preclinical • TNX - 701

  43. Slide 43: Milestones – Recently Completed and Upcoming

    © 2020 Tonix Pharmaceuticals Holding Corp. 43 Milestones – Recently Completed and Upcoming 1 □ September 2020 Interim analysis of TNX - 102 SL Phase 3 F304/RELIEF study in fibromyalgia completed □ 4 th Quarter 2020 Topline data from TNX - 102 SL Phase 3 F304/RELIEF study in fibromyalgia expected □ 4

  44. Slide 44: Management Team

    © 2020 Tonix Pharmaceuticals Holding Corp. 44 Management Team Seth Lederman, MD President & CEO Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger , CPA Chief Financial Officer

  45. Slide 45: Thank You!

    © 2020 Tonix Pharmaceuticals Holding Corp. 45 Thank You!

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