Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (August 2023)

47 slides from Tonix Pharmaceuticals's investor presentation, Aug 10, 2023

  1. Slide 1: Investor Presentation

    © 2023 Tonix Pharmaceuticals Holding Corp. INVESTOR PRESENTATION NASDAQ: TNXP Version P04 75 August 10, 2023 (Doc 1300 )

  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 Candidates* Indication Status/Next Milestone TNX - 102 SL 1 Fibromyalgia (FM) Long COVID (PASC 2 ) Mid - Phase 3 – enrollment complete Phase 2 – enrollment complete TNX - 1300 3 Cocaine Intoxication - FDA Breakt

  5. Slide 5: Late-Stage CNS Programs: Four Studies Expecting Topline

    5 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Late - Stage CNS Programs 1 Four Studies Expecting Topline in the Next Three Quarters (by End of 1Q24) Active Studies • 23Q3 - Topline: ‒ TNX - 102 SL for fibromyalgia - type Long COVID (enrollment complete) P2 Proof - of - Concept ▪ Clinica

  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 Zembrace ® SymTouch ® (sumatriptan injection) 3 mg 1 Tosymra ® (sumatriptan nasal spray) 10 mg 2 ‒ Each indicated for the treatment

  8. Slide 8: Tonix Medicines is our Commercial Subsidiary

    8 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tonix Medicines is our Commercial Subsidiary Marketed products for the treatment of acute migraine in adults with or without aura Zembrace ® SymTouch ® (sumatriptan injection) 3 mg 1 Tosymra ® (sumatriptan nasal spray) 10 mg 2 ‒ Both are pro

  9. Slide 9: Administration of Zembrace and Tosymra Bypass the GI Tract

    9 © 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

  10. Slide 10: Potential for Zembrace and Tosymra in Evolving Migraine Market

    10 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Potential for Zembrace and Tosymra in Evolving Migraine Market Documented efficacy of Zembrace 1,2 and Tosymra 3 - 5 as abortive treatments for acute migraine ‒ M igraine pain relief possible in as few as 10 minutes for some patients and co

  11. Slide 11: CNS: Key Development Candidates

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

  12. Slide 12: TNX-102 SL: Fibromyalgia 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

  13. Slide 13: TNX-102 SL: Fibromyalgia Development Program

    13 © 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

  14. Slide 14: TNX-102 SL: Phase 3 RESILIENT Study Design

    14 © 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

  15. Slide 15: TNX-102 SL: Fibromyalgia-Type Long COVID

    15 © 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

  16. Slide 16: Fibromyalgia-Type Long COVID

    16 © 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

  17. Slide 17: TNX-102 SL: Phase 2 PREVAIL Study Design

    17 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: 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 En

  18. Slide 18: TNX-1900: Prevention of Headache in Chronic Migraine

    18 © 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

  19. Slide 19: Magnesium Augments Oxytocin-Induced Analgesia in Animal Model

    19 © 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

  20. Slide 20: TNX-1900: Phase 2 PREVENTION Study Design

    20 © 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

  21. Slide 21: Potential Applications of TNX-1900 and TNX-2900

    21 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Potential Applications of TNX - 1900 and TNX - 2900 Adolescent Obesity Binge Eating Dis. Eating Behavior and Weight Disorders Autism Social Functioning Disorders Social Anxiety Disorder Migraine Craniofacial Pain Pain Conditions Phase 2 Stu

  22. Slide 22: TNX-2900: Hyperphagia in Prader-Willi Syndrome

    22 © 2023 Tonix Pharmaceuticals Holding Corp. RARE DISEASE PORTFOLIO Patents Issued PROFILE DEVELOPMENT PROGRAM TNX - 2900*: Hyperphagia in Prader - Willi Syndrome Intranasal Potentiated Oxytocin (OT) with Magnesium Prader - Willi Syndrome is the most common genetic cause of life - threatening child

  23. Slide 23: TNX-601 ER: Depression

    23 © 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

  24. Slide 24: TNX-601 ER: Phase 2 UPLIFT Study Design

    24 © 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

  25. Slide 25: Tianeptine is a Polyunsaturated Fatty Acid Analogue

    25 © 2023 Tonix Pharmaceuticals Holding Corp. Tianeptine is a Polyunsaturated Fatty Acid (PUFA) Analogue PUFAs and PUFA - analogues • Polar acidic “head” and hydrophobic fatty acid “tail” Pharmacological modulation of PUFA signaling has therapeutic potential in multiple pathologies • Act through the

  26. Slide 26: Racemic Tianeptine Composed of Two Isomers

    26 © 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

  27. Slide 27: TNX-4300: Depression, Alzheimer's & Parkinson's Diseases

    27 © 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

  28. Slide 28: (S)-Tianeptine Directly Affects Neuroplasticity

    28 © 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

  29. Slide 29: Tianeptine Shares Neuroplasticity Mechanism With Psychedelics

    29 © 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

  30. Slide 30: TNX-1300: Cocaine Intoxication

    30 © 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

  31. Slide 31: Immunology: Key Candidates

    © 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY: KEY CANDIDATES

  32. Slide 32: 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

  33. Slide 33: Third-Generation Anti-CD40L Engineered to Decrease Thrombosis Risk

    33 © 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

  34. Slide 34: Other Anti-CD40L Monoclonal Antibodies in Development

    34 © 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Other anti - CD40L Monoclonal Antibodies in Development UCB (Co - developed with Biogen) – Systemic Lupus Erythematosus (SLE) • Phase 3 Trial Currently Enrolling (NCT04294667) − Topline results expected 1H 2024 1 • Dapirolizumab pego

  35. Slide 35: TNX-1700: Gastric and Colorectal Cancers

    35 © 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Patents Filed TNX - 1700*: Gastric and Colorectal Cancers Recombinant Trefoil Factor 2 (rTFF2 - HSA) Fusion Protein Potential New Cancer Treatment • TNX - 1700 (rTFF2 - HSA) has effects on cancer by altering the tumor micro - environ

  36. Slide 36: Infectious Disease: Key Candidates

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

  37. Slide 37: 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 insert) purified from cell culture Next Steps: File IND Vaccine for Future

  38. Slide 38: Live Virus Vaccine Platform: Recombinant Pox Vaccine Technology

    38 © 2023 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Live Virus Vaccine Platform: Recombinant Pox Vaccine (RPV) Technology for Emerging Infectious Diseases and Oncolytics Mpox and Smallpox Future Pandemics & New Infectious Diseases COVID - 19 Biodefense Using Proven Science To

  39. Slide 39: Team, Capabilities, Network, & Upcoming Milestones

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

  40. Slide 40: Internal Development & Manufacturing Capabilities

    40 © 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

  41. Slide 41: Key Development Partners

    41 © 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

  42. Slide 42: Milestones: Recently Completed and Upcoming

    42 © 2023 Tonix Pharmaceuticals Holding Corp. Milestones: Recently Completed and Upcoming Expected Clinical Trial Initiations □ 3 rd Quarter 2023 Phase 1 study start of TNX - 1500 for prevention of allograft rejection □ 3 rd Quarter 2023 Phase 2 study start of TNX - 1300 for the treatment of cocaine

  43. Slide 43: Thank You

    © 2023 Tonix Pharmaceuticals Holding Corp. THANK YOU

  44. Slide 44: Zembrace Important Safety Information (1 of 2)

    44 © 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

  45. Slide 45: Zembrace Important Safety Information (2 of 2)

    45 © 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

  46. Slide 46: Tosymra Important Safety Information (1 of 2)

    46 © 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

  47. Slide 47: Tosymra Important Safety Information (2 of 2)

    47 © 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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