Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (September 2023)

54 slides from Tonix Pharmaceuticals's investor presentation, Sep 11, 2023

  1. Slide 1: Investor Presentation

    © 2023 Tonix Pharmaceuticals Holding Corp. INVESTOR PRESENTATION NASDAQ: TNXP Version P0482 September 11, 2023 (Doc 1312 )

  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: Investment Highlights

    3 © 2023 Tonix Pharmaceuticals Holding Corp. Investment Highlights RICH PIPELINE OF THERAPEUTICS CANDIDATES IN DEVELOPMENT Tonix’s core focus is on central nervous system disorders, but we also target unmet needs across multiple therapeutic areas including immunology, infectious disease and rare dis

  4. Slide 4: Pipeline: Key Clinical Development Programs

    4 © 2023 Tonix Pharmaceuticals Holding Corp. Pipeline: Key Clinical Development Programs Status/Next Milestone Indication Candidates* Mid - Phase 3 – enrollment complete Phase 2 – Topline Reported Fibromyalgia (FM) Long COVID (PASC 2 ) TNX - 102 SL 1 Mid - Phase 2, Targeted 4Q 2023 Start Cocaine Int

  5. Slide 5: Upcoming Expected Topline Results Fourth Quarter 2023

    5 © 2023 Tonix Pharmaceuticals Holding Corp. Upcoming Expected Topline Results Fourth Quarter 2023 TNX - 1900 for Chronic Migraine Topline Results Upcoming Phase 2 Proof - of - Concept Study Registration - Quality TNX - 601 ER for Depression Topline Results Upcoming Phase 2 Proof - of - Concept Stud

  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 Autoinjector and Nasal Spray (Non - oral) Formulations of Sumatriptan • Each indicated for the treatment of acute migraine with or without aura in adults • Sumatriptan remains the acute migraine ‘gold

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

    8 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Administration of Zembrace and Tosymra Bypass the GI Tract Bypassing the gastrointestinal (GI) tract is a potential advantage for treating acute migraine ‒ P otential to provide a treatment option for migraines complicated by severe nausea a

  9. Slide 9: CNS: Key Development Candidates

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

  10. Slide 10: TNX-102 SL Cyclobenzaprine (Protectic) Pipeline in a Product

    © 2023 Tonix Pharmaceuticals Holding Corp. TNX - 102 SL* Cyclobenzaprine ( Protectic ® ) Pipeline in a Product Fibromyalgia Status: Mid - Phase 3 • One positive Phase 3 study (RELIEF) completed • Second Phase 3 study (RALLY) missed primary endpoint • Confirmatory Phase 3 study (RESILIENT) enrollment

  11. Slide 11: Fibromyalgia-Type Long COVID

    11 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fibromyalgia - Type Long COVID • Long COVID is a heterogeneous condition that displays elements of nociplastic pain in many individuals, who experience otherwise unexplained symptoms 1 - 3 Symptoms (multi - site pain, fatigue, sleep disorde

  12. Slide 12: TNX-102 SL: Fibromyalgia-Type Long COVID (PASC)

    12 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 102 SL*: Fibromyalgia - Type Long COVID (PASC) Cyclobenzaprine Protectic ® Sublingual Tablets • Occurs in approximately 19% of recovered COVID - 19 patients 1 • As many as 40% of Long COVID p

  13. Slide 13: TNX-102 SL: Phase 2 PREVAIL Study Design

    13 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: Phase 2 PREVAIL Study Design Proof - of - Concept Study Study c haracteristics: • Randomized, double - blind, placebo - controlle d study of TNX - 102 SL in fibromyalgia - type Long COVID • U.S. sites only, 63 patients enrolle

  14. Slide 14: PREVAIL: Demographics and Baseline Characteristics

    14 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PREVAIL: Demographics and Baseline Characteristics 1 Tonix Press Release, September 5, 2023 - https://bit.ly/3Z6FQHQ Variable Placebo TNX-102 SL Total N=31 N=32 N=63 Age, mean years (SD) 51.4 (10.01) 48.6 (8.80) 50.0 (9.45) Female, number (

  15. Slide 15: PREVAIL Topline Results

    15 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PREVAIL Topline Results 1 TNX - 102 SL showed a robust effect size of 0.5 in improving fatigue and showed consistent activity across secondary measures of sleep quality, cognitive function, disability and Patient Global Impression of Change

  16. Slide 16: Primary Endpoint: Weekly Summary of Daily Pain Scores

    16 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Primary Endpoint: Weekly Summary of Daily Pain Scores 1 - 3 1 Tonix Press Release, September 5, 2023 - https://bit.ly/3Z6FQHQ 2 Change from baseline in the diary numerical rating scale (NRS) weekly average of daily self - reported worst Lon

  17. Slide 17: PREVAIL: Weekly Summary of Daily Sleep Scores

    17 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PREVAIL: Weekly Summary of Daily Sleep Scores 1 - 3 1 Tonix Press Release, September 5, 2023 - https://bit.ly/3Z6FQHQ 2 Change from baseline in the diary numerical rating scale (NRS) weekly average of daily self - reported sleep quality sco

  18. Slide 18: PREVAIL: PROMIS Sleep Disturbance

    18 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PREVAIL: PROMIS Sleep Disturbance 1,2 1 Tonix Press Release, September 5, 2023 - https://bit.ly/3Z6FQHQ 2 Mixed Model for Repeated Measures (MMRM), Abbreviations: LS, least squares; SE, standard error; SD, sleep disturbance -12 -10 -8 -6 -4

  19. Slide 19: PREVAIL: PROMIS Fatigue Score

    19 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PREVAIL: PROMIS Fatigue Score 1 - 5 1 Tonix Press Release, September 5, 2023 - https://bit.ly/3Z6FQHQ 2 Mixed Model for Repeated Measures (MMRM), Abbreviations: LS, least squares; SE, standard error 3 Cook, K.F., et al. 2016. Journal of Cli

  20. Slide 20: PREVAIL: Patient Global Impression of Change Responder Analysis

    20 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PREVAIL: Patient Global Impression of Change – Responder Analysis (V ery Much Improved or Much Improved) 1 1 Tonix Press Release, September 5, 2023 - https://bit.ly/3Z6FQHQ 12.9% 9.7% 12.9% 16.1% 9.4% 31.3% 28.1% 34.4% 0% 5% 10% 15% 20% 25%

  21. Slide 21: PREVAIL: Adverse Events

    21 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PREVAIL: Adverse Events 1 1 Tonix Press Release, September 5, 2023 - https://bit.ly/3Z6FQHQ Placebo TNX-102 SL Total N=31 N=32 N=63 Administration Site Reactions Hypoaesthesia oral 0 6 6 Product taste abnormal 0 3 3 Glossodynia 0 2 2 Oral p

  22. Slide 22: PREVAIL Next Steps

    22 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PREVAIL Next Steps Tonix plans to meet with FDA to discuss a path to registration ‒ Expected date of End of Phase 2 meeting is 1 st Quarter 2024 F atigue is the principal symptom overlapping with chronic fatigue syndrome/ myalgic encephalom

  23. Slide 23: Upcoming Expected Topline Results Fourth Quarter 2023

    23 © 2023 Tonix Pharmaceuticals Holding Corp. Upcoming Expected Topline Results Fourth Quarter 2023 TNX - 1900 for Chronic Migraine Topline Results Upcoming Phase 2 Proof - of - Concept Study Registration - Quality TNX - 601 ER for Depression Topline Results Upcoming Phase 2 Proof - of - Concept Stu

  24. Slide 24: TNX-102 SL: Fibromyalgia

    24 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 102 SL*: Fibromyalgia Cyclobenzaprine Protectic ® Sublingual Tablets CNS PORTFOLIO Fibromyalgia (FM) is a chronic pain disorder resulting from amplified sensory and pain signaling within the

  25. Slide 25: TNX-102 SL: Phase 3 RESILIENT Study Design

    25 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: Phase 3 R ESILIENT 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

  26. Slide 26: Upcoming Expected Topline Results Fourth Quarter 2023

    26 © 2023 Tonix Pharmaceuticals Holding Corp. Upcoming Expected Topline Results Fourth Quarter 2023 TNX - 1900 for Chronic Migraine Topline Results Upcoming Phase 2 Proof - of - Concept Study Registration - Quality TNX - 601 ER for Depression Topline Results Upcoming Phase 2 Proof - of - Concept Stu

  27. Slide 27: TNX-1900: Prevention of Headache in Chronic Migraine

    27 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 1900*: Prevention of Headache in Chronic Migraine Intranasal Potentiated Oxytocin (OT) with Magnesium CNS PORTFOLIO • Intranasal OT has potential utility in treating migraine 1 • Magnesium is

  28. Slide 28: Magnesium Augments Oxytocin-Induced Analgesia in Animal Model

    28 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO 1 Adapted from: Bharadwaj VN, et al. Pharmaceutics . 2022;14(5):1105. in vivo effect of Mg 2+ ion addition with intranasal oxytocin - induced craniofacial analgesia on the withdrawal response time to noxious heat stimulation of the cheek of

  29. Slide 29: TNX-1900: Phase 2 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 • Fully enrol

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

    30 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Potential Applications of TNX - 1900 and TNX - 2900 Phase 2 Study in Prevention of Headache in Chronic Migraine • Topline results expected 4Q 2023 Phase 2 Biomarker Study PWS* *Prader - Willi Syndrome Pain Conditions Migraine Phase 2 Study

  31. Slide 31: Upcoming Expected Topline Results Fourth Quarter 2023

    31 © 2023 Tonix Pharmaceuticals Holding Corp. Upcoming Expected Topline Results Fourth Quarter 2023 TNX - 1900 for Chronic Migraine Topline Results Upcoming Phase 2 Proof - of - Concept Study Registration - Quality TNX - 601 ER for Depression Topline Results Upco ming Phase 2 Proof - of - Concept St

  32. Slide 32: TNX-601 ER: Depression

    32 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 601 E R*: Depression Tianeptine Hemioxalate Extended - Release Tablets (39.4 mg) CNS PORTFOLIO • A novel, oral, extended - release once - daily tablet • Treatment effect of tianeptine sodium

  33. Slide 33: TNX-601 ER Phase 2 UPLIFT Study Design

    33 © 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

  34. Slide 34: Tianeptine Shares a Neuroplasticity-Promoting Mechanism With Psychedelics

    34 © 2023 Tonix Pharmaceuticals Holding Corp. The n eurotrophic growth factor BDNF plays a key role in the regulation of synaptic plasticity, and is diminished in populations suffering from anxiety and depression 1 • Psychedelics may promote neuroplasticity both by directly binding to BDNF receptor

  35. Slide 35: TNX-601 ER Racemic Tianeptine Composed of Two Isomers

    35 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 601 ER – Racemic Tianeptine – Composed of Two Isomers Racemic tianeptine : • Approved in Europe and ex - US • 1:1 mixture of 2 mirror r - image isomers 1,2 • Weak µ - o pioid receptor agonism 2 • Risk of abuse or diversion for euphori

  36. Slide 36: TNX-4300: Depression, Alzheimer's & Parkinson's Diseases

    36 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 4300*: Depression, Alzheimer’s & Parkinson’s diseases Estianeptine (Single (S) - isomer of Tianeptine) CNS PORTFOLIO • Single isomer, oral treatment • Proposed mechanism of action from lab st

  37. Slide 37: (S)-Tianeptine Cuts in Line to More Directly Affect Neuroplasticity

    37 © 2023 Tonix Pharmaceuticals Holding Corp. While Monoaminergic Antidepressants Work at the Synapse, (S) - Tianeptine “Cuts in Line” to More Directly Affect Neuroplasticity 1 Depressed Decreased connectivity and neuroplasticity Tianeptine + + mRNA ( eg , BDNF 2 ) 1 Sullivan G et al. Poster present

  38. Slide 38: TNX-1300: Cocaine Intoxication

    38 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 1300*: Cocaine Intoxication Cocaine Esterase ( CocE ) Cocaine is the main cause for drug - related ED visits 1 CocE is a recombinant protein that degrades cocaine in the bloodstream • Rapidly

  39. Slide 39: Immunology: Key Candidates

    © 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY: KEY CANDIDATES

  40. Slide 40: TNX-1500 Next Generation Anti-CD40L Antibody

    © 2023 Tonix Pharmaceuticals Holding Corp. TNX - 1500* Next Generation ߙ - CD40 Ligand (CD40L) Antibody The CD40 - CD40L pathway is a pivotal immune system modulator and a well - established and promising treatment target First Generation: Development halted due to thromboembolic (TE) complications

  41. Slide 41: Third-Generation Anti-CD40L Engineered to Decrease Risk of Thrombosis

    41 © 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Third - Generation α - CD40L Engineered to Decrease Risk of Thrombosis First - generation anti - CD40L mAbs Constant fragment (Fc) domain interacted with FcγRIIA (CD32A), which suggested a mechanism for the increased risk of thrombos

  42. Slide 42: TNX-1500 Anti-CD40L Monoclonal Antibody

    42 © 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 anti - CD40L Monoclonal Antibody 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 Tr

  43. Slide 43: Other Anti-CD40L Monoclonal Antibodies in Development

    43 © 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Other anti - CD40L Monoclonal Antibodies in Development Sanofi – Sjögren's Syndrome ( SjS ), Multiple Sclerosis (MS), Systemic Lupus Erythematosus (SLE) • Phase 2 Trial Currently Enrolling in SjS (NCT04572841) and SLE (NCT05039840) •

  44. Slide 44: Infectious Disease: Key Candidates

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

  45. Slide 45: TNX-801 Recombinant Pox Vaccine Platform

    © 2023 Tonix Pharmaceuticals Holding Corp. TNX - 801* Recombinant Pox Vaccine (RPV) Platform Using Live Virus Technology Mpox and Smallpox Vaccine Status: Preclinical • TNX - 801 is a cloned version of horsepox 1 (without any DNA insert) purified from cell culture Milestone: Successful completion of

  46. Slide 46: Team, Capabilities, Network, & Upcoming Milestones

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

  47. Slide 47: Internal Development & Manufacturing Capabilities

    47 © 2023 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Internal Development & Manufacturing Capabilities R&D Center (RDC) – Frederick, MD • Functions: ‒ Research advancing CNS and immunology drugs ‒ Accelerated development of vaccines and antiviral drugs against COVID - 19, its v

  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 - 1850: COVID - 19 VACCINE TNX - 2

  49. Slide 49: Upcoming: Expected Topline Clinical Data and Trial Initiations

    49 © 2023 Tonix Pharmaceuticals Holding Corp. Upcoming: Expected Topline Clinical Data and Trial Initiations 2023 3 rd Quarter Clinical Trial Initiations • Phase 1 study of TNX - 1500 for prevention of allograft rejection - started 4 th Quarter Clinical Trial Initiations • Phase 2 study of TNX - 130

  50. Slide 50: Thank You

    © 2023 Tonix Pharmaceuticals Holding Corp. THANK YOU

  51. Slide 51: Zembrace Important Safety Information (1 of 2)

    51 © 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

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

    52 © 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

  53. Slide 53: Tosymra Important Safety Information (1 of 2)

    53 © 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

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

    54 © 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,

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