Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (June 2021)

33 slides from Tonix Pharmaceuticals's investor presentation, Jun 28, 2021

  1. Slide 1: June 2021 Investor Presentation

    © 2021 Tonix Pharmaceuticals Holding Corp. 1 June 2021 Investor Presentation NASDAQ:TNXP Version P0305 6 - 28 - 2021 (Doc 0853)

  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: Our Pipeline – CNS Portfolio

    © 2021 Tonix Pharmaceuticals Holding Corp. 4 Our Pipeline – CNS Portfolio CANDIDATES INDICATION STATUS CNS Portfolio TNX - 102 SL 1 Fibromyalgia (FM) - Lead Program Mid - Phase 3 – ongoing PTSD Phase 3 ready Agitation in Alzheimer’s Phase 2 ready Alcohol Use Disorder Long COVID (PASC 2 ) Phase 2 rea

  5. Slide 5: Our Pipeline – Immunology & Biodefense Portfolio

    © 2021 Tonix Pharmaceuticals Holding Corp. 5 Our Pipeline – Immunology & Biodefense Portfolio CANDIDATES INDICATION STATUS Immunology Portfolio TNX - 1800 Covid - 19 vaccine – Prioritized Program 1 Phase 1, 1H 2022* TNX - 2100 SARS - CoV - 2 skin test for T cell immunity 2 First - in - human study Q

  6. Slide 6: TNX-102 SL FM Lead Program: Background on Fibromyalgia

    © 2021 Tonix Pharmaceuticals Holding Corp. 6 TNX - 102 SL FM Lead Program Background on Fibromyalgia Fibromyalgia (FM): A chronic condition Core symptoms: • widespread pain • sleep disturbance • fatigue • cognitive symptoms. Significant disabilities (impaired daily function). Course of disease can l

  7. Slide 7: Challenges with Current Pharmacotherapy

    © 2021 Tonix Pharmaceuticals Holding Corp. 7 Challenges with Current Pharmacotherapy Limitations of Current Therapies Fewer than half of those treated for fibromyalgia receive relief from the three FDA - approved drugs 1 • Lack of overall response leading to discontinuation or augmentation • Lack of

  8. Slide 8: Fibromyalgia Unmet Need and Ideal Treatment Profile

    © 2021 Tonix Pharmaceuticals Holding Corp. 8 Fibromyalgia Unmet Need and Ideal Treatment Profile Unmet Medical Need: Current treatment patterns indicate that new, more effective, and better - tolerated treatments are necessary for management of FM 1 Source: 1. Yang, et al, 2016 Ideal Treatment Profi

  9. Slide 9: TNX-102 SL: Engineered to Treat FM

    © 2021 Tonix Pharmaceuticals Holding Corp. 9 TNX - 102 SL: Engineered to Treat FM This unique formulation of cyclobenzaprine has been designed to optimize delivery and absorption, while minimizing the potential residual effects of oral formulations of cyclobenzaprine. Innovative and proprietary Prot

  10. Slide 10: Phase 3 F304/RELIEF Study: Design

    © 2021 Tonix Pharmaceuticals Holding Corp. 10 Phase 3 F304/RELIEF Study: Design Primary e ndpoint (Week 14) : • Daily diary pain severity score change from baseline Key Secondary e ndpoint s (Week 14): Symptom Relief • PROMIS Sleep Disturbance instrument T - score • PROMIS Fatigue instrument T - sco

  11. Slide 11: F304/RELIEF Study Topline Primary Efficacy Endpoint

    © 2021 Tonix Pharmaceuticals Holding Corp. 11 F304/RELIEF Study Topline Primary Efficacy Endpoint ◊ ◊ Primary Outcome Measure at Week 14 Placebo (N=255) TNX - 102 SL (N=248) Treatment Difference P value LS Mean Change from Baseline 1 (SE) - 1.5 (0.12) - 1.9 (0.12) - 0.4 (0.16) 0.010* Statistical Met

  12. Slide 12: F304/RELIEF Study: Primary Efficacy Endpoint Results (continued)

    © 2021 Tonix Pharmaceuticals Holding Corp. 12 F304/RELIEF Study: Primary Efficacy Endpoint Results (continued) -2.2 -2 -1.8 -1.6 -1.4 -1.2 -1 -0.8 -0.6 -0.4 -0.2 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 LS Mean Change from Baseline (SE) in NRS Pain Score Study Week RELIEF Study Mean Change from Baseline

  13. Slide 13: F304/RELIEF Study: Continuous Responder Analysis Graph

    © 2021 Tonix Pharmaceuticals Holding Corp. 13 P e r c e n t o f S u b j e c t s 0 10 20 30 40 50 60 70 80 90 100 Percentage Redution in Pain >=0% >=10% >=20% >=30% >=40% >=50% >=60% >=70% >=80% >=90% =100% Placebo TNX-102 SL Proportion of Subjects in Arm Cut - Off Points for Percentage Pain Responde

  14. Slide 14: F304/RELIEF Study: Key Secondary Efficacy Endpoints

    © 2021 Tonix Pharmaceuticals Holding Corp. 14 F304/RELIEF Study: Key Secondary Efficacy Endpoints ◊ ◊ *TNX - 102 SL is in clinical stage of development and not approved for any indication Outcome Measure at Week 14 Intent - to - Treat Analysis 1 P - value Non - Specific Patient Global Impression of

  15. Slide 15: Adverse Events in F304/RELIEF Study

    © 2021 Tonix Pharmaceuticals Holding Corp. 15 Adverse Events*(AEs) in F304/RELIEF Study Discontinuation rate due to adverse events: 8.9% TNX - 102 SL compared to 3.9% for placebo No serious and unexpected AEs in RELIEF related to TNX - 102 SL • Systemic AEs comparable with prior studies • Oral AEs s

  16. Slide 16: Approved Fibromyalgia Pharmacotherapies

    © 2021 Tonix Pharmaceuticals Holding Corp. 16 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

  17. Slide 17: TNX-102 SL Intellectual Property – U.S. Protection expected until 2035

    © 2021 Tonix Pharmaceuticals Holding Corp. 17 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, and Pa

  18. Slide 18: TNX-102 SL for FM: Next Steps

    © 2021 Tonix Pharmaceuticals Holding Corp. 18 TNX - 102 SL for FM: Next Steps 2 nd Phase 3 study, RALLY (F306) • Same protocol design as RELIEF study but with 200 more patients • Enrollment began in September 2020 • Interim cohort recruited in March 2021 • Clinical phase of interim cohort completed

  19. Slide 19: TNX-102 SL for Long COVID (PASC)

    © 2021 Tonix Pharmaceuticals Holding Corp. 19 TNX - 102 SL for Long COVID (PASC) Long COVID or Post - acute Sequelae of COVID - 19 (PASC) • Symptoms can include fatigue, sleep disorders, pain, fevers, shortness of breath, cognitive impairment described as “brain fo g”, gastrointestinal symptoms, anx

  20. Slide 20: COVID Vaccines with EUA: Still Uncertainty

    © 2021 Tonix Pharmaceuticals Holding Corp. 20 COVID - 19 Vaccines with Emergency Use Authorization (EUA): Still Uncertainty Durability of protection • Are vaccinated people protected one year later? • Need for annual vaccinations with mRNA vaccines? Will annual boosters work? • Durable protection is

  21. Slide 21: TNX-1800: a COVID-19 Vaccine Candidate

    © 2021 Tonix Pharmaceuticals Holding Corp. 21 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

  22. Slide 22: Potential Profile of TNX-1800 Compared to EUA Covid-19 Vaccines

    © 2021 Tonix Pharmaceuticals Holding Corp. 22 Potential Profile of TNX - 1800 Compared to EUA Covid - 19 Vaccines 22 Criteria EUA Vaccines TNX - 1800 Number of shots One – two One Duration Unknown Years / decades Boosters Unknown Not required Protection from variants Unknown Likely provides protecti

  23. Slide 23: TNX-3500: Antiviral for the Treatment of COVID-19

    © 2021 Tonix Pharmaceuticals Holding Corp. 23 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 (nanomolar activity against SARS - CoV - 2,

  24. Slide 24: TNX-2100: Potential Skin Test to Measure SARS-CoV-2 T Cell Immunity

    © 2021 Tonix Pharmaceuticals Holding Corp. 24 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

  25. Slide 25: TNX-1300: Cocaine Esterase (CocE)

    © 2021 Tonix Pharmaceuticals Holding Corp. 25 TNX - 1300: Cocaine Esterase (CocE) CocE is the most potent known catalyst for cocaine degradation • Natural bacterial CocE is unstable at body temperature Thermostable bacterial CocE (active for ~6 hours at body temperature) • Targeted mutations stabili

  26. Slide 26: TNX-1900 (Intranasal Potentiated Oxytocin) for Migraine

    © 2021 Tonix Pharmaceuticals Holding Corp. 26 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

  27. Slide 27: TNX-2900 for the Treatment of Prader-Willi Syndrome

    © 2021 Tonix Pharmaceuticals Holding Corp. 27 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

  28. Slide 28: TNX-601 CR for Major Depressive Disorder

    © 2021 Tonix Pharmaceuticals Holding Corp. 28 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 • Expect to open IND with a Human Abuse Potential s

  29. Slide 29: TNX-601 CR: A Potential Treatment for Depression

    © 2021 Tonix Pharmaceuticals Holding Corp. 29 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

  30. Slide 30: TNX-1500, a New CD40L Antibody, for Prevention of Allograft Rejection

    © 2021 Tonix Pharmaceuticals Holding Corp. 30 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 rejec

  31. Slide 31: Milestones – Recently Completed and Upcoming

    © 2021 Tonix Pharmaceuticals Holding Corp. 31 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

  32. Slide 32: Management Team

    © 2021 Tonix Pharmaceuticals Holding Corp. 32 Management Team Seth Lederman, MD President & CEO Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger , CPA Chief Financial Officer

  33. Slide 33: Thank You!

    © 2021 Tonix Pharmaceuticals Holding Corp. 33 Thank You!

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