Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (July 2023)

55 slides from Tonix Pharmaceuticals's investor presentation, Jul 31, 2023

  1. Slide 1: Investor Presentation

    © 2023 Tonix Pharmaceuticals Holding Corp. INVESTOR PRESENTATION NASDAQ: TNXP Version P04 67 July 31, 2023 (Doc 1287 )

  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 DIVERSE PIPELINE Tonix’s c ore focus is on central nervous system disorders , but we also target unmet needs across multiple therapeutic areas including immunology, infectious disease and rare disease. STRATEGIC PARTNERSHIPS Partneri

  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 – completing enrollment 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 • 23Q4 –

  6. Slide 6: Tonix Medicines is our Commercial Subsidiary

    6 © 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

  7. Slide 7: CNS: Key Development Candidates

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

  8. Slide 8: TNX-102 SL Cyclobenzaprine 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) completing

  9. Slide 9: TNX-102 SL Proprietary Eutectic Mixture Stabilizes Tablet

    9 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL (Sublingual Cyclobenzaprine HCl tablets*) Proprietary cyclobenzaprine HCl e utectic m ixture s tabilizes s ublingual t ablet f ormulation Base particle (K 2 HPO 4 ) Base particle (K 2 HPO 4 ) Base particle (K 2 HPO 4 ) C y cl o

  10. Slide 10: TNX-102 SL Sublingual Administration

    10 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL Sublingual Administration* Transmucosal absorption a voids first pass hepatic metabolism * U.S. Patent issued May 2, 2017 Swallowed Oral Dose Sublingual Oral Dose

  11. Slide 11: TNX-102 SL: Fibromyalgia

    11 © 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

  12. Slide 12: TNX-102 SL: Phase 3 RESILIENT Study Design

    12 © 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, enrolled approximately 450 patients Primary Endpoint: • Daily diary

  13. Slide 13: TNX-102 SL: Fibromyalgia-Type Long COVID (PASC)

    13 © 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 13% of recovered COVID - 19 patients 1 • As many as 40% of Long COVID p

  14. Slide 14: Fibromyalgia-Type Long COVID

    14 © 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

  15. Slide 15: TNX-102 SL: Phase 2 PREVAIL Study Design

    15 © 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

  16. Slide 16: TNX-601 ER: Depression

    16 © 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

  17. Slide 17: TNX-601 ER Phase 2 UPLIFT Study Design

    17 © 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

  18. Slide 18: Tianeptine is a Polyunsaturated Fatty Acid Analogue

    18 © 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

  19. Slide 19: Racemic Tianeptine – Composed of Two Isomers

    19 © 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

  20. Slide 20: TNX-4300: Depression, Alzheimer's & Parkinson's Diseases

    20 © 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

  21. Slide 21: Monoaminergic Antidepressants vs (S)-Tianeptine Mechanism

    21 © 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

  22. Slide 22: Tianeptine Shares Neuroplasticity Mechanism With Psychedelics

    22 © 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

  23. Slide 23: TNX-1900: Prevention of Headache in Chronic Migraine

    23 © 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

  24. Slide 24: TNX-1900: Phase 2 PREVENTION Study Design

    24 © 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

  25. Slide 25: TNX-1900 Other Studies with Academic Investigators

    25 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 1900 – Other Studies in Collaboration with Academic Investigators Pharmacodynamic biomarker study related to headache 1 ‒ Testing TNX - 1900 effects on capsaicin - or electrical stimulation - induced forehead dermal blood flow in heal

  26. Slide 26: TNX-1300: Cocaine Intoxication

    26 © 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

  27. Slide 27: Rare Disease: Key Candidates

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

  28. Slide 28: TNX-2900: Hyperphagia in Prader-Willi Syndrome

    28 © 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

  29. Slide 29: Immunology: Key Candidates

    © 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY: KEY CANDIDATES

  30. Slide 30: 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

  31. Slide 31: Third-Generation anti-CD40L Engineered to Decrease Thrombosis Risk

    31 © 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

  32. Slide 32: Other anti-CD40L Monoclonal Antibodies in Development

    32 © 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

  33. Slide 33: Infectious Disease: Key Candidates

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

  34. Slide 34: 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

  35. Slide 35: Live Virus Vaccine Platform: Recombinant Pox Vaccine Technology

    35 © 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

  36. Slide 36: Tonix Medicines: Marketed Products

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

  37. Slide 37: Two Marketed Proprietary Migraine Drugs

    37 © 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 treatme

  38. Slide 38: Zembrace SymTouch (sumatriptan injection) 3 mg

    38 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Zembrace ® SymTouch ® (sumatriptan injection) 3 mg Indication ‒ Indicated for the treatment of acute migraine with or without aura in adults Design ‒ O nly branded sumatriptan autoinjector professionally promoted in the United States ‒ Desi

  39. Slide 39: Tosymra (sumatriptan nasal spray) 10 mg

    39 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tosymra ® (sumatriptan nasal spray) 10 mg Indication ‒ Indicated for the treatment of acute migraine with or without aura in adults Design ‒ Novel intranasal sumatriptan product formulated with a permeation enhancer ( Intravail ® technology

  40. Slide 40: Potential for Zembrace and Tosymra in Evolving Migraine Market

    40 © 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

  41. Slide 41: Administration of Zembrace and Tosymra Bypass the GI Tract

    41 © 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

  42. Slide 42: Strategic Fit

    42 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Strategic Fit We expect commercial business of Zembrace and Tosymra will be under our control in 4Q: and projected fibromyalgia topline for TNX - 102 SL is expected 1Q24 ‒ With success in F307 trial, commercial business is expected to speed

  43. Slide 43: Value to Tonix of Marketed Proprietary Migraine Drugs

    43 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Value to Tonix of Marketed Proprietary Migraine Drugs Prepare for the launch of TNX - 102 SL for fibromyalgia ‒ Commercial capabilities prior to expected launch of TNX - 102 SL may speed market uptake ‒ Potential to facilitate launch of TNX

  44. Slide 44: Preclinical Pipeline

    © 2023 Tonix Pharmaceuticals Holding Corp. PRECLINICAL PIPELINE

  45. Slide 45: Internal Development & Manufacturing Capabilities

    45 © 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

  46. Slide 46: Pipeline: Key Pre-Clinical Programs

    46 © 2023 Tonix Pharmaceuticals Holding Corp. Pipeline: Key Pre - Clinical Programs TNX - 1850 3 COVID - 19 (horsepox - based live virus vaccine platform) Preclinical TNX - 801 4 Smallpox and mpox vaccine Preclinical TNX - 3900 Filoviruses (broad spectrum antiviral) Preclinical TNX - 4000 Filoviruse

  47. Slide 47: TNX-1700: Gastric and Colorectal Cancers

    47 © 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

  48. Slide 48: Tonix Team, Network and Future Outlook

    © 2023 Tonix Pharmaceuticals Holding Corp. TONIX TEAM, NETWORK AND FUTURE OUTLOOK

  49. Slide 49: Key Development Partners

    49 © 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

  50. Slide 50: Milestones: Recently Completed and Upcoming

    50 © 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

  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,

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