Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (February 2021)

74 slides from Tonix Pharmaceuticals's investor presentation, Feb 19, 2021

  1. Slide 1: Investor Presentation

    © 2021 Tonix Pharmaceuticals Holding Corp. 1 February 2021 Version P0274 2 - 19 - 2021 (Doc 0787) Investor Presentation NASDAQ:TNXP

  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

    © 2021 Tonix Pharmaceuticals Holding Corp. 3 Tonix Pharmaceuticals Clinical - stage biopharmaceutical company • Committed to discovering and developing innovative and proprietary new therapeutics Focus on developing biologics and small molecules • Central Nervous System (CNS) • Lead: fibromyalgia pr

  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 - Related Sleep Disturbance 2 Phase 3 ready Agitation in Alzheimer’s Phase 2 ready Alcohol Use Disorder Ph

  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 Preclinical TNX - 1810, TNX - 1820, TNX - 1830 Covid - 19 vaccine 1 Preclinical TNX - 2100 SARS - CoV

  6. Slide 6: TNX-102 SL: New Potential Treatment for the Management of Fibromyalgia

    © 2021 Tonix Pharmaceuticals Holding Corp. 6 TNX - 102 - SL 1 : New Potential Treatment for the Management of Fibromyalgia 1 TNX - 102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication.

  7. Slide 7: Background on Fibromyalgia

    © 2021 Tonix Pharmaceuticals Holding Corp. 7 Background on Fibromyalgia Fibromyalgia: Chronic condition that causes widespread pain all over the body, sleep problems, fatigue, and often emotional and mental distress 1 American Chronic Pain Association (www.theacpa.org, 2019) 2 . Walitt, B., Nahin, R

  8. Slide 8: Current Pharmacotherapy for Fibromyalgia

    © 2021 Tonix Pharmaceuticals Holding Corp. 8 Current Pharmacotherapy for Fibromyalgia 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 • Inadequate response fo

  9. Slide 9: Fibromyalgia Unmet Need and Ideal Treatment Profile

    © 2021 Tonix Pharmaceuticals Holding Corp. 9 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 Ideal Treatment Profile: Works by a different mech

  10. Slide 10: TNX-102 SL 5.6 mg: Results from Completed Positive Phase 3 RELIEF Study

    © 2021 Tonix Pharmaceuticals Holding Corp. 10 TNX - 102 SL 5.6 mg: Results from Completed Positive Phase 3 RELIEF Study Completed Positive Trial in FM: • Topline results announced in December 2020 • 503 participants randomized across 39 sites in U.S. • 95% of participants were women Topline Efficacy

  11. Slide 11: No Recognized Abuse Potential in Clinical Studies

    © 2021 Tonix Pharmaceuticals Holding Corp. 11 No Recognized Abuse Potential in Clinical Studies Active ingredient is cyclobenzaprine, which is structurally related to tricyclic antidepressants • Cyclobenzaprine interacts with receptors that regulate sleep quality: 5 - HT 2A, a 1 - adrenergic, histam

  12. Slide 12: Positive Phase 3 F304/RELIEF Study: Design

    © 2021 Tonix Pharmaceuticals Holding Corp. 12 Positive Phase 3 F304/RELIEF Study: Design 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 numerical rating scale (NRS), using mixed model rep

  13. Slide 13: F304/RELIEF Study Topline Data: Primary Efficacy Endpoint

    © 2021 Tonix Pharmaceuticals Holding Corp. 13 F304/RELIEF Study Topline Data: Statistical Significance Achieved on Pre - specified Primary Efficacy Endpoint (p=0.01) ◊ ◊ 2 TNX - 102 SL is in clinical stage of development and not approved for any indication Primary Outcome Measure at Week 14 Placebo

  14. Slide 14: F304/RELIEF Study: Primary Efficacy Endpoint Results (continued)

    © 2021 Tonix Pharmaceuticals Holding Corp. 14 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

  15. Slide 15: F304/RELIEF Study: Key Secondary Efficacy Endpoints

    © 2021 Tonix Pharmaceuticals Holding Corp. 15 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

  16. Slide 16: F304/RELIEF Study: Continuous Responder Analysis Graph

    © 2021 Tonix Pharmaceuticals Holding Corp. 16 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

  17. Slide 17: Adverse Events in F304/RELIEF Study

    © 2021 Tonix Pharmaceuticals Holding Corp. 17 Adverse Events* (AEs) in F304/ RELIEF Study TNX - 102 SL (N=248) Placebo (N=255) Total (N=503) Administration Site Reactions N % N % N % Tongue/mouth numbness 43 17.3 2 0.8 45 8.9 Tongue/mouth pain/discomfort 29 11.7 5 2.0 34 6.8 Taste impairment 16 6.5

  18. Slide 18: Safety and Tolerability in F304/RELIEF Study

    © 2021 Tonix Pharmaceuticals Holding Corp. 18 Safety and Tolerability in F304/RELIEF Study • No new safety signals in RELIEF at TNX - 102 SL 5.6 mg dose • 82.3% in active arm and 83.5% in placebo arm completed the study • 8.9% in active arm and 3.9% in placebo arm discontinued due to adverse events

  19. Slide 19: TNX-102 SL 5.6 mg for Fibromyalgia: Phase 3 F306/RALLY Study

    © 2021 Tonix Pharmaceuticals Holding Corp. 19 TNX - 102 SL 5.6 mg for Fibromyalgia: 2 nd Phase 3 F306/RALLY Study – Enrollment Ongoing 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 numer

  20. Slide 20: Approved Fibromyalgia Pharmacotherapies

    © 2021 Tonix Pharmaceuticals Holding Corp. 20 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

  21. Slide 21: Other Fibromyalgia Pharmacotherapies in Development in the U.S.

    © 2021 Tonix Pharmaceuticals Holding Corp. 21 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

  22. Slide 22: TNX-102 SL: PTSD-related Sleep Disturbance

    © 2021 Tonix Pharmaceuticals Holding Corp. 22 TNX - 102 SL 1 : PTSD - related Sleep Disturbance 2 1 TNX - 102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication. 2 Refined indication of PTSD - related sleep disturbance pending agre

  23. Slide 23: Overview of Posttraumatic Stress Disorder (PTSD)

    © 2021 Tonix Pharmaceuticals Holding Corp. 23 Overview of Posttraumatic Stress Disorder (PTSD) PSTD is a chronic disabling disorder in response to experiencing traumatic event(s) Symptoms of PTSD fall into four clusters: 1. Intrusion (aversive memories, nightmares, flashbacks) 2. Avoidance (avoiding

  24. Slide 24: PTSD: Prevalence and Demographics

    © 2021 Tonix Pharmaceuticals Holding Corp. 24 PTSD: Prevalence and Demographics PTSD is a chronic response to traumatic event(s) • A majority of people will experience a traumatic event at some point in their lifetime 1 • 20% of women and 8% of men in the U.S. who experience significant trauma devel

  25. Slide 25: TNX-102 SL: Hypothesized Novel Mechanism Targets Sleep Quality

    © 2021 Tonix Pharmaceuticals Holding Corp. 25 TNX - 102 SL: Hypothesized Novel Mechanism Targets Sleep Quality for Recovery from PTSD PTSD is a disorder of recovery • Most people exposed to extreme trauma recover over a few weeks • In PTSD, recovery process impeded due to insufficient sleep - depend

  26. Slide 26: TNX-102 SL for PTSD: Phase 3 P302/RECOVERY Study Design

    © 2021 Tonix Pharmaceuticals Holding Corp. 26 TNX - 102 SL for PTSD: Completed Phase 3 P302/RECOVERY, Study Design Placebo once - daily at bedtime 12 weeks TNX - 102 SL once - daily at bedtime 5.6 mg (2 x 2.8 mg tablets) General s tudy c haracteristics: • Randomized, double - blind, placebo - contro

  27. Slide 27: P302/RECOVERY Topline Results

    © 2021 Tonix Pharmaceuticals Holding Corp. 27 P302/RECOVERY Topline Results Trial Efficacy Endpoints TNX - 102 SL (N=80) Placebo (N=83) TNX - 102 SL v. Placebo Week 12 Outcome Measure LS Mean SE LS Mean SE LSMD SE 95% CI p - value* ES CAPS - 5 CFB – Primary Endpoint - 20.7 1.97 - 18.5 1.9 - 2.2 2.3

  28. Slide 28: P302/RECOVERY Topline Results: Safety Endpoints

    © 2021 Tonix Pharmaceuticals Holding Corp. 28 P302/RECOVERY Topline Results Safety Endpoints TNX - 102 SL (N=80) Placebo (N=84) Change in Outcome Measure Mean 95% CI Mean 95% CI Weight (kg) 0.03 - 0.48, 0.54 0.58 - 0.01, 1.16 Systolic blood pressure (mmHg) 1.8 - 0.8, 4.5 1.3 - 1.4, 4.0 Diastolic blo

  29. Slide 29: P302/RECOVERY Topline Results: Effects on Female Sexual Function

    © 2021 Tonix Pharmaceuticals Holding Corp. 29 P302/RECOVERY Topline Results Effects of TNX - 102 SL on Female Sexual Function TNX - 102 SL (N=65) Placebo (N=64) TNX - 102 SL v. Placebo Wk 12 Outcome Measure LS Mean SE LS Mean SE LSMD SE 95% CI p - value** ES CSFQ - 14 CFB* (female) 4.6 0.84 2.4 0.86

  30. Slide 30: TNX-102 SL for PTSD: Three Recent Trials

    © 2021 Tonix Pharmaceuticals Holding Corp. 30 TNX - 102 SL for Posttraumatic Stress Disorder (PTSD): Three Recent Trials Phase 3 P302 “RECOVERY” – Civilian PTSD (79% female) 1 • Reported Topline in December 2020 ( mITT , N = 163) • 2 groups: Placebo (n = 83) and TNX 5.6 mg (n = 80) • Primary endpoin

  31. Slide 31: Adverse Event Profile of TNX-102 SL 5.6 mg in PTSD Trials

    © 2021 Tonix Pharmaceuticals Holding Corp. 31 Adverse Event Profile of TNX - 102 SL 5.6 mg in Phase 3 Trials in Both Civilian (P302) and Military - Related (P301) PTSD # Only adverse events (AEs) are listed that are at a rate of ≥ 5% in the TNX - 102 SL - treated groups *No values in a row for eithe

  32. Slide 32: Common Observations from Three Recent PTSD Trials

    © 2021 Tonix Pharmaceuticals Holding Corp. 32 Common Observations from Three Recent PTSD Trials Testing TNX - 102 SL • Consistent nominal improvement or trend at Week 12 for sleep measurements • Supported by nominal benefits in PROMIS Sleep Disturbance and E6 sleep disturbance item in CAPS - 5 analy

  33. Slide 33: Sleep Disturbance Recognized as Clinically Valid Approach to Address PTSD

    © 2021 Tonix Pharmaceuticals Holding Corp. 33 Sleep Disturbance Recognized as Clinically Valid Approach to Address PTSD VA Study on Sleep in PTSD currently recruiting non - registrational 4 - arm study of trazodone, eszopiclone, gabapentin and placebo on VA PTSD patients 1 • Insomnia Severity Index

  34. Slide 34: Future Plans: TNX-102 SL for PTSD

    © 2021 Tonix Pharmaceuticals Holding Corp. 34 Future Plans: TNX - 102 SL for PTSD Plan to propose new indication: “PTSD - related sleep disturbance” • Sleep disturbance is a core symptom of PTSD • TNX - 102 SL works by improving sleep quality which, as a result, improves sleep - dependent emotional

  35. Slide 35: TNX-102 SL Intellectual Property – U.S. Protection expected until 2035

    © 2021 Tonix Pharmaceuticals Holding Corp. 35 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

  36. Slide 36: Opportunities to Expand TNX-102 SL to Other Indications

    © 2021 Tonix Pharmaceuticals Holding Corp. 36 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

  37. Slide 37: TNX-1800: a COVID-19 Vaccine Candidate

    © 2021 Tonix Pharmaceuticals Holding Corp. 37 TNX - 1800 1 : a COVID - 19 Vaccine Candidate 1 TNX - 1800 (horsepox/Cov - 2 spike live vaccine) is at the pre - IND stage of development

  38. Slide 38: TNX-1800: a COVID-19 Vaccine Candidate

    © 2021 Tonix Pharmaceuticals Holding Corp. 38 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

  39. Slide 39: Concerns With Current COVID-19 Vaccines with EUA

    © 2021 Tonix Pharmaceuticals Holding Corp. 39 Concerns With Current COVID - 19 Vaccines with Emergency Use Authorization (EUA) • Durability of protection • Are vaccinated people protected one year later? • Durable protection is associated with T cell response • Protection against death/ventilator su

  40. Slide 40: Warp-Speed COVID-19 Vaccines: Live Virus Vaccines Take Longer to Develop

    © 2021 Tonix Pharmaceuticals Holding Corp. 40 Warp - Speed COVID - 19 Vaccines: Live Virus Vaccines Take Longer to Develop • mRNA • Moderna (mRNA - 1273, LNP 1 - encapsulated CoV - 2 Spike [“Spike”] mRNA) EUA 2 • Pfizer & BioNTech ( LNP - encapsulated Spike mRNA ) EUA • Subunit • Sanofi/GSK (recombi

  41. Slide 41: COVID-19 Vaccine Landscape

    © 2021 Tonix Pharmaceuticals Holding Corp. 41 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

  42. Slide 42: Live, Attenuated Virus Vaccines for Other Infectious Diseases

    © 2021 Tonix Pharmaceuticals Holding Corp. 42 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

  43. Slide 43: TNX-1800 Vaccination of Non-Human Primates Elicited Neutralizing Antibodies

    © 2021 Tonix Pharmaceuticals Holding Corp. 43 TNX - 1800 Vaccination of Non - Human Primates Elicited Anti - SARS - CoV - 2 Neutralizing Antibodies and Skin Reaction or “Take” in All Eight Animals STUDY DESIGN :  Compares TNX - 1800 (modified horsepox virus encoding CoV - 2 spike protein) to TNX -

  44. Slide 44: TNX-1800 Vaccination of Non-Human Primates: Findings, Conclusions and Next Phase

    © 2021 Tonix Pharmaceuticals Holding Corp. 44 TNX - 1800 Vaccination of Non - Human Primates Findings, Conclusions and Next Phase TOLERABILITY :  TNX - 1800 and TNX - 801 were well tolerated at both doses. DOSE:  Supports the expectation that TNX - 1800 at the low dose of 1 x 10 6 PFU is an approp

  45. Slide 45: TNX-1800: Engineered for Long-term Immunity

    © 2021 Tonix Pharmaceuticals Holding Corp. 45 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 • TNX - 1800 has 99.7% colinear identity with circa 1860 smallpox vaccine 2 • Eradicated smallpox (o

  46. Slide 46: Why Use a Horsepox Platform for a Vaccine?

    © 2021 Tonix Pharmaceuticals Holding Corp. 46 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

  47. Slide 47: TNX-1800 is Based on a Horsepox Virus Vector

    © 2021 Tonix Pharmaceuticals Holding Corp. 47 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

  48. Slide 48: Vaccinia Induces a Skin Reaction Called “Take”

    © 2021 Tonix Pharmaceuticals Holding Corp. 48 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

  49. Slide 49: Unique Challenges of SARS-CoV-2

    © 2021 Tonix Pharmaceuticals Holding Corp. 49 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 Nov. 2020) 5 Rate of infectivity 1,4 Incubation time 2,4 As

  50. Slide 50: Infection of Type II Pneumocytes Can Lead to Lethal Respiratory Illness

    © 2021 Tonix Pharmaceuticals Holding Corp. 50 Infection of Type II Pneumocytes Can Lead to Lethal Respiratory Illness Capillary Type II pneumocytes Inhalation Exhalation Type II pneumocytes in the alveoli secrete pulmonary surfactants that are necessary for effective gas exchange. 2 SARS - CoV - 2 I

  51. Slide 51: SARS-CoV-2 Hijacks the Respiratory System to Spread Contagious Virus

    © 2021 Tonix Pharmaceuticals Holding Corp. 51 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

  52. Slide 52: CoV-Specific T Cells Kill the Virus Factories

    © 2021 Tonix Pharmaceuticals Holding Corp. 52 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

  53. Slide 53: Contrasting T cell and Antibody Immunity

    © 2021 Tonix Pharmaceuticals Holding Corp. 53 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

  54. Slide 54: TNX-1800: Potential Development and Uses

    © 2021 Tonix Pharmaceuticals Holding Corp. 54 TNX - 1800: Potential Development and Uses • Potential to protect against CoV - 2 Variants • T cell epitopes are short stretches of peptides (~8 - 14 aa fragments) that so far seem to be conserved between variants • Clinical trials will test potential pr

  55. Slide 55: COVID-19 Vaccine Platform: Bovine Parainfluenza (BPI) Virus

    © 2021 Tonix Pharmaceuticals Holding Corp. 55 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

  56. Slide 56: TNX-2100: Diagnostic Product Candidate to Test for SARS-CoV-2 T Cell Immunity

    © 2021 Tonix Pharmaceuticals Holding Corp. 56 TNX - 2100 1 : Diagnostic Product Candidate to Test for SARS - CoV - 2 T Cell Immunity 1 TNX - 2100 is in the pre - investigational new drug (IND) stage of development and has not been approved for any indication.

  57. Slide 57: TNX-2100: Potential Skin Test to Measure SARS-CoV-2 Exposure and T Cell Immunity

    © 2021 Tonix Pharmaceuticals Holding Corp. 57 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) • Based on mixtures of synthetic peptides for intradermal administration • Desig

  58. Slide 58: TNX-2100: Potential Uses and Development Plans

    © 2021 Tonix Pharmaceuticals Holding Corp. 58 TNX - 2100: Potential Uses and Development Plans TNX - 2100 has the potential to serve as: • a biomarker for cellular immunity and protective immunity • a method to stratify participants in COVID - 19 vaccine trials by immune status • an endpoint in COVI

  59. Slide 59: TNX-1300: New Potential Treatment for Cocaine Intoxication

    © 2021 Tonix Pharmaceuticals Holding Corp. 59 TNX - 1300 1 : New Potential Treatment for Cocaine Intoxication 1 TNX - 1300 is an investigational new biologic and has not been approved for any indication.

  60. Slide 60: TNX-1300 for the Treatment of Cocaine Intoxication

    © 2021 Tonix Pharmaceuticals Holding Corp. 60 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

  61. Slide 61: TNX-1300 Is a Fast-acting Cocaine Antidote

    © 2021 Tonix Pharmaceuticals Holding Corp. 61 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

  62. Slide 62: TNX-1300 Development Plan

    © 2021 Tonix Pharmaceuticals Holding Corp. 62 TNX - 1300 Development Plan 62 • 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

  63. Slide 63: TNX-1900: New Potential Treatment for Migraine and Craniofacial Pain

    © 2021 Tonix Pharmaceuticals Holding Corp. 63 TNX - 1900 1 : New Potential Treatment for Migraine and Craniofacial Pain 1 TNX - 1900 is at the pre - IND stage of development. A Phase 2 trial under an investigator - initiated IND has been completed in the U .S. using TNX - 1900.

  64. Slide 64: TNX-1900 for the Treatment of Migraine and Craniofacial Pain – Overview

    © 2021 Tonix Pharmaceuticals Holding Corp. 64 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

  65. Slide 65: TNX-1900 for the Treatment of Migraine – Prevalence

    © 2021 Tonix Pharmaceuticals Holding Corp. 65 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

  66. Slide 66: TNX-1900 for the Treatment of Migraine – Mechanism of Action

    © 2021 Tonix Pharmaceuticals Holding Corp. 66 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

  67. Slide 67: 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

  68. Slide 68: 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

  69. Slide 69: TNX-1900 for the Treatment of Migraine – Development Status

    © 2021 Tonix Pharmaceuticals Holding Corp. 69 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

  70. Slide 70: Pipeline Summary – by Select Therapeutic Areas

    © 2021 Tonix Pharmaceuticals Holding Corp. 70 Pipeline 1 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 Sleep Disturbance Phase 3/R

  71. Slide 71: Pipeline Summary – by Select Therapeutic Areas (continued)

    © 2021 Tonix Pharmaceuticals Holding Corp. 71 Pipeline 1 Summary – by Select Therapeutic Areas (continued) Oncology • TNX - 1700 (rTFF2 2 ) for treatment of gastric and pancreatic cancer Preclinical Public Health • TNX - 1800, TNX - 1810, TNX - 1820 & TNX - 1830 (live modified horsepox vaccine) for

  72. Slide 72: Milestones – Recently Completed and Upcoming

    © 2021 Tonix Pharmaceuticals Holding Corp. 72 Milestones – Recently Completed and Upcoming 1 □ 4 th Quarter 2020 Non - human primate immune response positive results reported □ 4 th Quarter 2020 Positive topline data from TNX - 102 SL Phase 3 F304/RELIEF study in fibromyalgia reported □ 1 st Quarter

  73. Slide 73: Management Team

    © 2021 Tonix Pharmaceuticals Holding Corp. 73 Management Team Seth Lederman, MD President & CEO Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger , CPA Chief Financial Officer

  74. Slide 74: Thank You!

    © 2021 Tonix Pharmaceuticals Holding Corp. 74 Thank You!

Tonix Pharmaceuticals Holding — Investor Presentation (February 2021) on 6ix