Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (August 2020)

39 slides from Tonix Pharmaceuticals's investor presentation, Aug 3, 2020

  1. Slide 1: Investor Presentation

    © 2020 Tonix Pharmaceuticals Holding Corp. 1 August 2020 Version P0239 8 - 3 - 20 (Doc 0679) 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: Developing novel therapies for humanity

    © 2020 Tonix Pharmaceuticals Holding Corp. 3 Tonix Pharmaceuticals © 2020 Tonix Pharmaceuticals Holding Corp . Developing novel therapies for humanity • A clinical - stage biopharmaceutical company committed to discovering and developing innovative and proprietary new therapeutics that address the n

  4. Slide 4: Our Pipeline – CNS Portfolio

    © 2020 Tonix Pharmaceuticals Holding Corp. 4 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 Pre - Investigational New Drug (IND) meeting completed in October 2019 with FDA. Upon recei

  5. Slide 5: Our Pipeline – Immunology Portfolio

    © 2020 Tonix Pharmaceuticals Holding Corp. 5 Our Pipeline – Immunology Portfolio CANDIDATES INDICATION STATUS Immunology Portfolio TNX - 1800 Covid - 19 vaccine – Prioritized Program 1 Preclinical TNX - 2300 Covid - 19 vaccine 2 Preclinical TNX - 801 Smallpox and monkeypox preventing vaccine 3 Precl

  6. Slide 6: TNX-1800, a SARS-CoV-2 Vaccine Candidate

    © 2020 Tonix Pharmaceuticals Holding Corp. 6 TNX - 1800 1 , a SARS - CoV - 2 Vaccine Candidate Utilizes Tonix’s proprietary horsepox virus as a vector • Designed to express a protein from SARS - CoV - 2, the cause of COVID - 19 • Collaboration with Southern Research • Manufacturing agreement with FU

  7. Slide 7: COVID-19 Vaccine Landscape

    © 2020 Tonix Pharmaceuticals Holding Corp. 7 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

  8. Slide 8: Unique Challenges of SARS-CoV-2

    © 2020 Tonix Pharmaceuticals Holding Corp. 8 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,

  9. Slide 9: Why Use a Horsepox Platform for a Vaccine?

    © 2020 Tonix Pharmaceuticals Holding Corp. 9 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 – direct

  10. Slide 10: TNX-1800 is Based on a Horsepox Virus Vector

    © 2020 Tonix Pharmaceuticals Holding Corp. 10 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

  11. Slide 11: TNX-1800 is Designed to Induce Robust TH1 Cellular Immunity

    © 2020 Tonix Pharmaceuticals Holding Corp. 11 TNX - 1800 is Designed to Induce Robust T H 1 Cellular Immunity 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 15, 2020. http

  12. Slide 12: Contrasting T cell and Antibody Immunity

    © 2020 Tonix Pharmaceuticals Holding Corp. 12 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

  13. Slide 13: TNX-1800 Development Status

    © 2020 Tonix Pharmaceuticals Holding Corp. 13 TNX - 1800 Development Status Southern Research will address two key questions: • Will vaccination of animals elicit an immune response to the S protein? • 4th Quarter 2020 – Small animal response expected 1 • Will immune response protect non - human pri

  14. Slide 14: TNX-2300, a SARS-CoV-2 Vaccine Candidate

    © 2020 Tonix Pharmaceuticals Holding Corp. 14 TNX - 2300 1 , a 2 nd SARS - CoV - 2 Vaccine Candidate 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 - ligand to stimulat

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

    © 2020 Tonix Pharmaceuticals Holding Corp. 15 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 replicatio

  16. Slide 16: Overview of TNX-102 SL Protectic formulation

    © 2020 Tonix Pharmaceuticals Holding Corp. 16 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

  17. Slide 17: TNX-102 SL: Differentiation from Oral Formulations

    © 2020 Tonix Pharmaceuticals Holding Corp. 17 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

  18. Slide 18: TNX-102 SL: Results from Completed Fibromyalgia Trials

    © 2020 Tonix Pharmaceuticals Holding Corp. 18 TNX - 102 SL: Results from Completed Fibromyalgia (FM) Trials Completed Trials in FM: • Phase 2 (F202 BESTFIT) – 205 patients randomized • Phase 3 (F301 AFFIRM) – 519 patients randomized Topline Efficacy Results: • Studies did not achieve statistical sig

  19. Slide 19: Phase 2b F202 and Phase 3 F301 Efficacy Results

    © 2020 Tonix Pharmaceuticals Holding Corp. 19 p=0.005 p=0.038 P<0.001 P<0.001 P<0.001 Phase 3 F301 (AFFIRM) Dose: 2.8 mg Responder analysis ≥ 30% pain reduction (Logistic regression) • Imbalance in missing data and individuals with missing data treated as ‘non - responder’ • Current FDA statistical

  20. Slide 20: F301 Results Using Current FDA Statistical Guidance

    © 2020 Tonix Pharmaceuticals Holding Corp. 20 Results from F301 (AFFIRM) Using Current FDA Statistical Guidance on Handling of Missing Data • A retrospective analysis conducted using Mean Pain Analysis, MMRM with MI † demonstrated a significant effect on pain, even though the dose was 2.8 mg -1.8 -1

  21. Slide 21: Where Are We on the Dose-Response Curve?

    © 2020 Tonix Pharmaceuticals Holding Corp. 21 Where Are We on the Dose - Response Curve? Basic Pharmacology • Dose can make the difference in the strength of the response Response Dosage Dose - Response Inconsistent response No clear response Consistent response Consistent but trade - offs* (AEs) *T

  22. Slide 22: Dose Response from Phase 2 PTSD Study

    © 2020 Tonix Pharmaceuticals Holding Corp. 22 Dose Response from Phase 2 PTSD Study * Placebo 5.6 mg 2.8 mg * P < 0.05 Consistent Dose - response Across Primary and Key Secondary Endpoints at Week 12 • Clinician Administered PTSD Scale for DSM - 5 (CAP - 5) * Phase 2 study (AtEase), a randomized, pl

  23. Slide 23: Dose Response from Phase 2 PTSD Study: SDS

    © 2020 Tonix Pharmaceuticals Holding Corp. 23 Dose Response from Phase 2 PTSD Study Placebo 5.6 mg 2.8 mg * P < 0.05 Consistent Dose - response Across Primary and Key Secondary Endpoints at Week 12 • Sheehan Disability Score (SDS) -3 -2.5 -2 -1.5 -1 -0.5 0 SDS Work/School -4 -3.5 -3 -2.5 -2 -1.5 -1

  24. Slide 24: Dose Response from Phase 2 PTSD Study: CGI-I, PGIC

    © 2020 Tonix Pharmaceuticals Holding Corp. 24 Dose Response from Phase 2 PTSD Study 0% 10% 20% 30% 40% 50% 60% 70% Percent Responders CGI - I Responders 2.45 2.5 2.55 2.6 2.65 2.7 2.75 2.8 2.85 2.9 2.95 Mean Score PGIC Improvement Placebo 5.6 mg 2.8 mg * P < 0.05 * * Improvement Improvement • Consis

  25. Slide 25: Effect of Dose on Adverse Events in PTSD Studies

    © 2020 Tonix Pharmaceuticals Holding Corp. 25 Effect of Dose on Adverse Events (AEs) in the P201/ AtEase and P301/HONOR 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) i

  26. Slide 26: TNX-102 SL: Ongoing Phase 3 Study in FM (RELIEF)

    © 2020 Tonix Pharmaceuticals Holding Corp. 26 TNX - 102 SL: On - going Phase 3 Study in FM (F304/RELIEF) © 2020 Tonix Pharmaceuticals Holding Corp. • Key changes to protocol from previous Phase 3 trial in FM • Exclusive use of higher dose of 5.6 mg (2 x 2.8 mg) • Primary endpoint: mean pain improvem

  27. Slide 27: Lead Programs Summary

    © 2020 Tonix Pharmaceuticals Holding Corp. 27 Tonix Pharmaceuticals: Lead Programs Summary 1 © 2020 Tonix Pharmaceuticals Holding Corp. • TNX - 102 SL for fibromyalgia (FM) • Phase 3 clinical development – RELIEF study fully enrolled • Sublingual cyclobenzaprine tablets at higher dose of 5.6 mg • Mi

  28. Slide 28: Opportunities to Expand TNX-102 SL to Other Indications

    © 2020 Tonix Pharmaceuticals Holding Corp. 28 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

  29. Slide 29: TNX-102 SL: Potential Treatment for Agitation in Alzheimer's Disease

    © 2020 Tonix Pharmaceuticals Holding Corp. 29 TNX - 102 SL: Potential Treatment for Agitation in Alzheimer’s Disease (AAD) Agitation is one of the most distressing and debilitating of the behavioral complications of Alzheimer’s disease • Includes emotional lability, restlessness, irritability and ag

  30. Slide 30: TNX-102 SL: Potential Treatment for Alcohol Use Disorder

    © 2020 Tonix Pharmaceuticals Holding Corp. 30 TNX - 102 SL: Potential Treatment for Alcohol Use Disorder (AUD) AUD is a chronic relapsing brain disease • Characterized by compulsive alcohol use, loss of control over alcohol intake, and a negative emotional state when not using Sleep disturbance is e

  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: Psychiatry, Immunology and Oncology Preclinical Pipeline

    © 2020 Tonix Pharmaceuticals Holding Corp. 33 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

  34. Slide 34: Pipeline Summary – by Select Therapeutic Areas

    © 2020 Tonix Pharmaceuticals Holding Corp. 34 Pipeline Summary – by Select Therapeutic Areas Pain Psychiatry Addiction Medicine • TNX - 102 SL (sublingual cyclobenzaprine) for fibromyalgia Phase 3/RELIEF • TNX - 102 SL (sublingual cyclobenzaprine) for PTSD Phase 3/RECOVERY • TNX - 102 SL (sublingual

  35. Slide 35: Pipeline Summary – by Select Therapeutic Areas

    © 2020 Tonix Pharmaceuticals Holding Corp. 35 Pipeline Summary – by Select Therapeutic Areas Pain Psychiatry Addiction Medicine • TNX - 102 SL (sublingual cyclobenzaprine) for fibromyalgia Phase 3/RELIEF • TNX - 102 SL (sublingual cyclobenzaprine) for PTSD Phase 3/RECOVERY • TNX - 102 SL (sublingual

  36. Slide 36: Pipeline Summary – by Select Therapeutic Areas (continued)

    © 2020 Tonix Pharmaceuticals Holding Corp. 36 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

  37. Slide 37: Milestones – Recently Completed and Upcoming

    © 2020 Tonix Pharmaceuticals Holding Corp. 37 Milestones – Recently Completed and Upcoming 1 □ 2 nd Quarter 2020 Submitted IND application for TNX - 102 SL to support Phase 2 POC study in AUD □ September 2020 Interim analysis results from TNX - 102 SL Phase 3 F304/RELIEF study in fibromyalgia expect

  38. Slide 38: Management Team

    © 2020 Tonix Pharmaceuticals Holding Corp. 38 Management Team Seth Lederman, MD President & CEO Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger , CPA Chief Financial Officer

  39. Slide 39: Thank You!

    © 2020 Tonix Pharmaceuticals Holding Corp. 39 Thank You! 39 RK124

Tonix Pharmaceuticals Holding — Investor Presentation (August 2020) on 6ix