Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (October 2023)

55 slides from Tonix Pharmaceuticals's investor presentation, Oct 16, 2023

  1. Slide 1: Corporate Presentation October 2023

    © 2023 Tonix Pharmaceuticals Holding Corp. Corporate Presentation October 2023 NASDAQ: TNXP Version P0496 October 16, 2023 (Doc 1332 )

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

    2 © 2023 Tonix Pharmaceuticals Holding Corp. 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: Who We Are

    © 2023 Tonix Pharmaceuticals Holding Corp. 3 Who We Are Tonix is committed to developing and marketing therapeutics to treat pain, neurologic, psychiatric and addiction conditions through our central nervous system portfolio and within other areas of high unmet need , including immunology, infectiou

  4. Slide 4: Focused Biopharma with Preclinical to Commercial Stage Products

    4 © 2023 Tonix Pharmaceuticals Holding Corp. CNS - Focused Biopharma with Preclinical to Commercial Stage Products Marketed Products For the treatment of acute migraine Robust Development Pipeline Topline data for three late - stage CNS programs expected by end of 2023 Internal Facilities For R&D an

  5. Slide 5: Late-Stage Clinical Portfolio

    5 © 2023 Tonix Pharmaceuticals Holding Corp. NDA Submission Phase 3 Phase 2 Phase 1 Indication Molecule* Fibromyalgia (FM) TNX - 102 SL Cyclobenzaprine Protectic ® Sublingual Tablets FM - Type Long COVID Major Depressive Disorder TNX - 601 ER Tianeptine Hemioxalate Extended - Release Tablets Chronic

  6. Slide 6: Tonix Medicines: Marketed Products

    © 2023 Tonix Pharmaceuticals Holding Corp. TONIX MEDICINES: MARKETED PRODUCTS

  7. Slide 7: Two Marketed Proprietary Migraine Drugs

    7 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Two Marketed Proprietary Migraine Drugs Non - oral Formulations of Sumatriptan • Each indicated for the tr eatment of acute migraine with or without aura in adults • Sumatriptan remains the acute migraine ‘gold standard’ treatment for many p

  8. Slide 8: Zembrace and Tosymra Bypass the GI Tract

    8 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Zembrace and Tosymra Bypass the GI Tract Bypassing gastrointestinal (GI) tract is potential advantage for treating acute migraine • GI absorption may be inconsistent in migraineurs due to gastric stasis (also called “gastroparesis”) 1 - 4 •

  9. Slide 9: Upcoming Expected Topline Results Fourth Quarter 2023

    9 © 2023 Tonix Pharmaceuticals Holding Corp. Upcoming Expected Topline Results Fourth Quarter 2023 TNX - 1900 for Chronic Migraine Topline Results Expected – early December Phase 2 Proof - of - Concept Study TNX - 601 ER for Depression Topline Results Expected – early November Phase 2 Potential Pivo

  10. Slide 10: Key Development Candidates

    © 2023 Tonix Pharmaceuticals Holding Corp. CNS: KEY DEVELOPMENT CANDIDATES

  11. Slide 11: TNX-102 SL Cyclobenzaprine (Protectic)

    11 © 2023 Tonix Pharmaceuticals Holding Corp. TNX - 102 SL Cyclobenzaprine ( Protectic ® ) A unique, sublingual formulation of cyclobenzaprine designed to optimize delivery and absorption

  12. Slide 12: Unique MOA Facilitates Restorative Sleep

    Unique MOA Facilitates Restorative Sleep: Centrally Acting Analgesic 12 Potent binding and antagonist activities at four key receptors facilitate restorative sleep • serotonergic - 5 - HT2A • adrenergic - α1 • histaminergic - H1 • muscarinic - M1 Relative to Oral Cyclobenzaprine o Lower daytime expo

  13. Slide 13: Fibromyalgia Overview

    13 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CNS PORTFOLIO Fibromyalgia a fflicts an estimated 6 - 12 million adults in the US, predominantly women 1 1 American Chronic Pain Association (www.theacpa.org, 2019) 2 Robinson et al, Pain Medicine 2013;14:1400 3 The three drugs with FDA app

  14. Slide 14: Fibromyalgia Program Status

    14 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fibromyalgia Program Status Fibromyalgia TNX - 102 SL Cyclobenzaprine Protectic ® Sublingual Tablets FM - Type Long COVID Phase 3 Topline Results Expected 4Q’23 (Late December) Phase 2 Topline Results Reported 3Q’23 1) One positive Phase 3

  15. Slide 15: RESILIENT Study Design

    15 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Phase 3 RESILIENT Study Design General s tudy c haracteristics: • Randomized, double - blind, placebo - controlle d study in fibromyalgia • U.S. sites only, completed enrollment of 457 patients Primary Endpoint: • Daily diary pain severity

  16. Slide 16: About Fibromyalgia-Type Long COVID

    16 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO About Fibromyalgia - Type Long COVID Many Long - COVID symptoms overlap with core symptoms of fibromyalgia and are hallmarks of other chronic pain syndromes like myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) Multisite pain Mem

  17. Slide 17: PREVAIL Study Design

    17 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Phase 2 PREVAIL Study Design Study c haracteristics: • Randomized, double - blind, placebo - controlle d study of TNX - 102 SL in fibromyalgia - type Long COVID • U.S. sites only, completed enrollment of 63 patients Primary Endpoint: • Dail

  18. Slide 18: PREVAIL Topline Results

    18 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Phase 2 PREVAIL Topline Results 1 D id not meet the primary endpoint of multi - site pain reduction at W eek 14 However, f indings fulfill the objectives of proof - of - concept study, supporting the decision to advance the program b ased o

  19. Slide 19: TNX-601 ER Tianeptine Hemioxalate Extended-Release Tablets

    19 © 2023 Tonix Pharmaceuticals Holding Corp. TNX - 601 ER Tianeptine Hemioxalate Extended - Release Tablets An innovative approach to treating depression

  20. Slide 20: Improved Formulation of Tianeptine Promotes Neuroplasticity

    Improved Formulation of Tianeptine Promotes Neuroplasticity 20 Unique mechanism of action – beyond neurotransmitter modulation Key Differentiators © 2023 Tonix Pharmaceuticals Holding Corp. Relative to tianeptine immediate release available ex - US o Once daily dosing Relative to traditional antidep

  21. Slide 21: Tianeptine Composed of Two Isomers

    21 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tianeptine Composed of Two Isomers Racemic tianeptine (TNX - 601) : • Approved in Europe and ex - US • 1:1 mixture of 2 mirror r - image isomers 1,2 • Weak µ - o pioid receptor agonism 2 (S) - t ianeptine (R) - tianeptine 1 Stablon. Summary

  22. Slide 22: About Major Depressive Disorder

    22 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CNS PORTFOLIO Depression afflicts nearly 47 million adults in the US (18.4% of population) About Major Depressive Disorder Major depressive disorder (MDD) is a leading cause of disability worldwide, with 21 million adults in the US alone ex

  23. Slide 23: TNX-601 ER UPLIFT Study Design

    23 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 601 ER - Phase 2 UPLIFT* Study Design General s tudy c haracteristics: • Randomized, double - blind, placebo - controlle d study in Major Depressive Disorder to evaluate monotherapy with TNX - 601 ER versus placebo • Parallel design w

  24. Slide 24: (S)-Tianeptine Directly Affects Neuroplasticity

    24 © 2023 Tonix Pharmaceuticals Holding Corp. While Monoaminergic Antidepressants Work at the Synapse, (S) - Tianeptine “Cuts in Line” to More Directly Affect Neuroplasticity 1 Decreased connectivity and neuroplasticity 1 Sullivan G et al. Poster presentation at the American Society of Clinical Psyc

  25. Slide 25: TNX-1900 and TNX-2900 Intranasal Potentiated Oxytocin

    25 © 2023 Tonix Pharmaceuticals Holding Corp. TNX - 1900 and TNX - 2900 Intranasal Potentiated Oxytocin with Magnesium A n ovel, non - CGRP antagonist approach to treatment

  26. Slide 26: Intranasal Oxytocin Potentiated with Magnesium

    Novel Formulation of Intranasal Oxytocin (OT) Potentiated with Magnesium 26 Magnesium is known to potentiate the binding of OT to its receptor 1 ,2 Key Differentiators © 2023 Tonix Pharmaceuticals Holding Corp. Oxytocin receptor Oxytocin o Targeted intranasal delivery • Low systemic exposure o Block

  27. Slide 27: Magnesium Augments Oxytocin-Induced Analgesia in Animal Model

    27 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO 1 Adapted from: Bharadwaj VN, et al. Pharmaceutics . 2022;14(5):1105. Vehicle 0.5 1 4 8 32 0 5 10 15 20 Oxytocin only Oxytocin with 300 mM Mg 2+ * * * * Oxytocin dose (µg) Withdrawal latency (seconds) C Fiber Response 1 * P <0.05 Oxytocin E

  28. Slide 28: About Chronic Migraine

    28 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CNS PORTFOLIO Chronic migraine afflicts 3 - 7 million adults in the US 1 About Chronic Migraine Chronic migraine involves frequent (>15 days per month) or long - lasting episodes of headaches and migraines over the course of at least 3 mont

  29. Slide 29: TNX-1900 PREVENTION Study Design

    29 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 1900: Phase 2 PREVENTION Study Design General s tudy c haracteristics: • Randomized, double - blind, placebo - controlle d study (three arms – two treatment regimens and one placebo) in chronic migraine • U.S. sites only, completed en

  30. Slide 30: Potential Applications of TNX-1900 & TNX-2900

    30 © 2023 Tonix Pharmaceuticals Holding Corp. Potential Applications of TNX - 1900 & TNX - 2900: Investigator Led Studies Adolescent Obesity Binge Eating Dis. Eating Behavior and Weight Disorders Autism Social Functioning Disorders Social Anxiety Disorder Migraine Craniofacial Pain Pain Conditions P

  31. Slide 31: About Prader-Willi Syndrome

    31 © 2023 Tonix Pharmaceuticals Holding Corp. RARE DISEASE PORTFOLIO Rare genetic diseas e that afflicts 10 - 20 thousand individuals in the US About Prader - Willi Syndrome Prader - Willi Syndrome (PWS) is the most common genetic cause of life - threatening childhood obesity. PWS causes unhealthy b

  32. Slide 32: TNX-1300 Cocaine Esterase

    32 © 2023 Tonix Pharmaceuticals Holding Corp. TNX - 1300 Cocaine Esterase Fast acting antidote for life threatening cocaine intoxication

  33. Slide 33: Recombinant Protein Rapidly Degrades Cocaine in the Bloodstream

    Recombinant Protein Rapidly Degrades Cocaine in the Bloodstream 33 Drops plasma exposure by 90% in 2 minutes Key Differentiators © 2023 Tonix Pharmaceuticals Holding Corp. o Rapidly metabolizes cocaine within matter of minutes o N o other product currently on the market for this indication CocE Coca

  34. Slide 34: About Cocaine Intoxication

    34 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CNS PORTFOLIO Over 500,000 emergency department visits for cocaine, annually 3,4 About Cocaine Intoxication Over 5 million Americans reported current cocaine use in 2020, which is almost 2% of the population 1 . In 2021, more than 24,900 in

  35. Slide 35: Immunology: Key Candidates

    © 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY: KEY CANDIDATES

  36. Slide 36: TNX-1500 Anti-CD40L Monoclonal Antibody

    36 © 2023 Tonix Pharmaceuticals Holding Corp. TNX - 1500 Anti - CD40L Monoclonal Antibody Next Generation mAb preserves efficacy without risk of thrombosis

  37. Slide 37: Next Generation anti-CD40L mAb

    Next Generation anti - CD40L mAb 37 Re - engineered to better modulate the binding of Fc ઻ R and mitigate risk of thrombosis Key Differentiators © 2023 Tonix Pharmaceuticals Holding Corp. Selectively Modified anti - CD40L AB Ruplizumab full Fab Contains the full ruplizumab Fab and the engineered Fc

  38. Slide 38: TNX-1500 Strategy and Status

    38 © 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 Strategy and Status 1 Lassiter, G . , et al . ( 2023 ) . TNX - 1500 , a crystallizable fragment – modified anti - CD 154 antibody, prolongs non - human primate renal allograft survival . American Journal of Transplantation

  39. Slide 39: TNX-1700 Recombinant TFF2-HSA Fusion Protein

    39 © 2023 Tonix Pharmaceuticals Holding Corp. TNX - 1700 Recombinant Trefoil Factor Family Member 2 (rTFF2 - HSA) Fusion Protein Targeting the toxic tumor micro - environment

  40. Slide 40: Fighting Cancer by Targeting the Tumor Micro-Environment

    Fighting Cancer by Targeting the Tumor Micro - Environment 40 S uppresses myeloid - derived suppressor cells (MDSCs) and activates anti - cancer CD8+ T cells o Different MOA than checkpoint inhibitors o Potential synergy with anti - PD - 1 or anti - PD - L1 monoclonal antibodies Key Differentiators

  41. Slide 41: About Gastric and Colorectal Cancer

    41 © 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO People living with colorectal cancer in the US 2 About Gastric and Colorectal Cancer Gastric and colorectal cancer are both leading cancers in the US. C olorectal cancer is the 3 rd leading cause of cancer - related deaths in both me

  42. Slide 42: Infectious Disease: Key Candidates

    © 2023 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE: KEY CANDIDATES

  43. Slide 43: Internal Development & Manufacturing Capabilities

    43 © 2023 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Internal Development & Manufacturing Capabilities R&D Center (RDC): Frederick, MD • Research advancing CNS and immunology drugs • Accelerated development of vaccines and antiviral drugs against infectious diseases • ~48,000 s

  44. Slide 44: Broad-Spectrum Antiviral Discovery Programs

    44 © 2023 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Broad - Spectrum Antiviral Discovery Programs Host - directed antiviral discovery programs CD45 targeted therapeutics • Small molecule therapeutics that reduce endogenous levels of CD45, a protein tyrosine phosphatase • Reduc

  45. Slide 45: TNX-801 Live Virus Vaccine

    45 © 2023 Tonix Pharmaceuticals Holding Corp. TNX - 801 Live Virus Vaccine Live virus vaccine platform with multitude of potential applications

  46. Slide 46: Recombinant Pox Vaccine Platform Using Live Virus Technology

    Recombinant Pox Vaccine (RPV) Platform Using Live Virus Technology 46 C loned version of horsepox 1 purified from cell culture Key Differentiators © 2023 Tonix Pharmaceuticals Holding Corp. TNX - 801* scHPXV (Horsepox) 212,811 bp *TNX - 801 is in the pre - IND stage of development and has not been a

  47. Slide 47: Team, Network, & Upcoming Milestones

    © 2023 Tonix Pharmaceuticals Holding Corp. TEAM, NETWORK, & UPCOMING MILESTONES

  48. Slide 48: Key Development Partners

    48 © 2023 Tonix Pharmaceuticals Holding Corp. TNX - 1300: COCAINE INTOXICATION TNX - 1700: GASTRIC AND COLORECTAL CANCERS Key Development Partners TNX - 1500: ALLOGRAFT REJECTION TNX - 1900: MIGRAINE & OTHER INDICATIONS TNX - 801: SMALLPOX AND MONKEYPOX VACCINE TNX - 2900: PRADER - WILLI SYNDROME

  49. Slide 49: Management Team

    49 © 2023 Tonix Pharmaceuticals Holding Corp. Management Team Seth Lederman, MD Co - Founder, CEO & Chairman Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger, CPA Chief Financial Officer

  50. Slide 50: Summary of Upcoming Milestones

    50 © 2023 Tonix Pharmaceuticals Holding Corp. Summary of Upcoming Milestones 4 th Quarter 2023 Clinical Trial Initiations • Phase 2 study of TNX - 1300 for the treatment of cocaine intoxication - expected 4 th Quarter 2023 Data Readouts • Phase 2 UPLIFT study of TNX - 601 ER for major depressive dis

  51. Slide 51: Thank You

    © 2023 Tonix Pharmaceuticals Holding Corp. THANK YOU

  52. Slide 52: Zembrace Important Safety Information (1 of 2)

    52 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Zembrace ® Important Safety Information (1 of 2) Zembrace SymTouch ( Zembrace ) can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs

  53. Slide 53: Zembrace Important Safety Information (2 of 2)

    53 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Zembrace ® Important Safety Information (2 of 2) Zembrace may cause serious side effects including: • Changes in color or sensation in your fingers and toes; sudden or severe stomach pain, stomach pain after meals, weight loss, na usea or v

  54. Slide 54: Tosymra Important Safety Information (1 of 2)

    54 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tosymra® Important Safety Information (1 of 2) Tosymra® can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop Tosymra and get emergency medical help if you have any signs of heart att

  55. Slide 55: Tosymra Important Safety Information (2 of 2)

    55 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tosymra may cause serious side effects including: • Changes in color or sensation in your fingers and toes; sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea,

Tonix Pharmaceuticals Holding — Investor Presentation (October 2023) on 6ix