Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (May 2024)

41 slides from Tonix Pharmaceuticals's investor presentation, May 21, 2024

  1. Slide 1: Corporate Presentation Abbreviated Focus on Tonmya (TNX-102 SL) for Fibromyalgia

    © 2024 Tonix Pharmaceuticals Holding Corp. Corporate Presentation Abbreviated Focus on: Tonmya * (TNX - 102 SL) in Development for the Management of Fibromyalgia May 2024 NASDAQ: TNXP * Tonmya is conditionally accepted by FDA as the tradename for TNX - 102 SL for the management of fibromyalgia Versi

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

    2 © 2024 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

    3 © 2024 Tonix Pharmaceuticals Holding Corp. 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, infectious disease,

  4. Slide 4: Key Clinical Programs

    4 © 2024 Tonix Pharmaceuticals Holding Corp. NDA Submission Phase 3 Phase 2 Phase 1 Indication Molecule * Fibromyalgia Tonmya TNX - 102 SL Cyclobenzaprine HCl Protectic ® Sublingual Tablets Long COVID Acute Stress Disorder Cocaine Intoxication TNX - 1300 Cocaine Esterase NIDA Funded Prader - Willi S

  5. Slide 5: Tonmya (TNX-102 SL, Cyclobenzaprine HCl Sublingual Tablets)

    5 © 2024 Tonix Pharmaceuticals Holding Corp. Tonmya (TNX - 102 SL, Cyclobenzaprine HCl Sublingual Tablets) A unique, sublingual formulation of cyclobenzaprine designed to optimize delivery and absorption Tonmya is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename

  6. Slide 6: About Fibromyalgia

    6 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO About Fibromyalgia Fibromyalgia is considered a chronic overlapping pain condition (COPC) - the only COPC with any FDA - approved drugs 3 Fibromyalgia is the prototypic nociplastic syndrome Multisite pain Fatigue Non - Restorative Sleep Fibr

  7. Slide 7: Fibromyalgia is a Large, Underserved and Dissatisfied Population

    7 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fibromyalgia is a Large, Underserved and Dissatisfied Population* • ~10 million U.S. adults are affected – predominantly women 1,2 ‒ Debilitating and life altering condition ‒ Significant economic impact • Patients are dissatisfied, despite

  8. Slide 8: Poor Sleep and Pain have Bi-directional Reinforcing Effects

    8 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Poor Sleep and Pain have Bi - directional Reinforcing Effects 1 1 Moldofsky H, et al. J Rheumatol . 1996;23:529 – 533. 2 Grönbald M, et al. Clin Rheumatol . 1993;12(2):186 – 191 • Poor sleep and pain form a vicious cycle in driving fibromyal

  9. Slide 9: Tonmya (TNX-102 SL, Cyclobenzaprine HCl Sublingual Tablets)

    9 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tonmya (TNX - 102 SL, Cyclobenzaprine HCl Sublingual Tablets) 1 • Non - opioid analgesic designed for long - term daily bedtime use in fibromyalgia patients ‒ Targets non - restorative sleep ‒ Potent binding and antagonist activities at four

  10. Slide 10: TNX-102 SL: Sublingual Administration and Transmucosal Delivery

    10 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: Sublingual Administration and Transmucosal Delivery • Advantages of the sublingual route • Faster absorption provides PK that is ideal for bedtime dosing • Bypasses “first - pass” hepatic metabolism • Reduced metabolism of par

  11. Slide 11: Fibromyalgia Program Status

    11 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fibromyalgia Program Status Fibromyalgia Tonmya * (TNX - 102 SL) Cyclobenzaprine Protectic ® Sublingual Tablets Statistically Significant 2 nd Phase 3 Topline Results Reported 4Q’23 First pivotal Phase 3 study ( RELIEF ) reported – December

  12. Slide 12: RESILIENT Primary Outcome Measure: Reduction in Widespread Pain

    12 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Weekly Average of Daily Diary NRS Ratings of Average Pain Over Prior 24 Hours RESILIENT Primary Outcome Measure Reduction in Widespread Pain -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 (SE

  13. Slide 13: RESILIENT Summary of Endpoints

    13 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT Summary of Endpoints *In order of statistical serial gate - keeping hierarchy (or, “waterfall”) to control overall Type 1 error **Statistical significance met Effect Size (ES) P - value Endpoint Primary Endpoint ES = 0.38 p = 0.00

  14. Slide 14: RESILIENT – Cognitive Dysfunction or Brain Fog

    14 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT – Cognitive Dysfunction or “Brain Fog” Brain Fog assessed by the FIQ - R 1 item on memory • P atients rated their level of memory problems • 11 - pt scale going from “Good Memory” to “Very Poor Memory” • Prespecified endpoint, but

  15. Slide 15: Tonmya Showed Broad-Spectrum Activity and was Well Tolerated

    15 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tonmya Showed Broad - Spectrum Activity and was Well Tolerated Tonmya Cymbalta® Savella ® Lyrica® YES YES YES Pain Activity YES - YES Sleep YES YES - Fatigue - + - Insomnia Systemic Tolerability Issues - - + Fatigue - - + Weight - + - Blood

  16. Slide 16: Safety and Tolerability

    16 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Safety and Tolerability • Completion Rate (safety population): TNX - 102 SL: 81.0% and Placebo: 79.2% • No new safety signals observed • Only systemic adverse events (AEs) at rate ≥ 3.0% (TNX - 102 SL v. Placebo) ‒ COVID - 19 (4.3% v. 3.1%)

  17. Slide 17: RESILIENT Safety Summary

    17 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT Safety Summary *Safety Population Treatment - Emergent Adverse Events (TEAEs) at Rate of ≥ 3% in Either Treatment Group Total* N=457 Placebo N=226 TNX - 102 SL N=231 System Organ Class Preferred Term Systemic Adverse Events 17 (3.

  18. Slide 18: ~50% of U.S. Fibromyalgia Patients are on Medicare

    18 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO ~50% of U.S. Fibromyalgia Patients are on Medicare: Prescription Coverage in Medicare Stands to Benefit from Changes in IRA Approximately 50% of fibromyalgia patients are on Medicare ‒ EVERSANA analysis of claims database consisting of 2.2M

  19. Slide 19: Prescribers Broadly Dissatisfied with Available Fibromyalgia Medications

    19 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Prescribers Interviewed are Broadly Dissatisfied with Available Fibromyalgia Medications: Results of Primary Research 1 Perspectives on FM Therapies from Prescribers Interviewed Negatives Positives Drug • Tolerability issues: worsening depr

  20. Slide 20: Opportunity for a New, Unique Fibromyalgia Treatment Option

    20 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Opportunity for a New, Unique Fibromyalgia Treatment Option: Results of Primary Research from EVERSANA 1,2 • Prescribers indicate a very high unmet need in FM (ranked ≥4.0 on a 5 - point scale) • Prescribers report there is no standard of c

  21. Slide 21: Many Fibromyalgia Patients are Prescribed Off-Label Drugs

    21 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Many Fibromyalgia Patients are Prescribed Off - Label Drugs; ~53% FM Patients Prescribed Opioids Off - Label 1,2 1.04% 6.03% 11.74% 12.96% 13.23% 17.58% 19.45% 20.47% 22.62% 25.50% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% Milnacipran Amitr

  22. Slide 22: Planning for Tonmya Launch and Marketing

    22 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Planning for Tonmya Launch and Marketing Several companies that successfully developed CNS drugs have launched them • Big Pharma wants the commercial launch de - risked before acquisition ( e.g. , Nurtec ®) To prepare for the launch of Tonm

  23. Slide 23: Two Marketed Proprietary Migraine Drugs

    23 © 2024 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

  24. Slide 24: CNS-Focused Biopharma with Preclinical, Clinical and Commercial Assets

    24 © 2024 Tonix Pharmaceuticals Holding Corp. Marketed Products • Zembrace ® and Tosymra ® indicated for the treatment of acute migraine Tonmya fo r Fibromyalgia: Preparing New Drug Application (NDA) • Two Phase 3 trials completed with statistical significance on primary endpoint • NDA filing expect

  25. Slide 25: Additional Potential Indications for Tonmya (TNX-102 SL)

    25 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Additional Potential Indications for Tonmya (TNX - 102 SL) Fibromyalgia - Type Long COVID • Status: Phase 2 • Phase 2 study ( PREVAIL ) completed • Topline results reported 3Q 2023 Next Steps: Meet with FDA Acute Stress Reaction/ Acute Stre

  26. Slide 26: Additional Programs and Pipeline Strategy

    26 © 2024 Tonix Pharmaceuticals Holding Corp. Additional Programs and Pipeline Strategy Focusing on government and academic collaborations • Validates Tonix’s scientific expertise and technology • Reduces internal spend • Increases number of trials • Potentially speeds tim e to market • Grants, cont

  27. Slide 27: TNX-1500: Next Generation anti-CD40L mAb

    TNX - 1500: Next Generation anti - CD40L mAb 27 Re - engineered to better modulate the binding of Fc ઻ R and mitigate risk of thrombosis Clinical Stage of Phase 1 study completed Key Differentiators © 2024 Tonix Pharmaceuticals Holding Corp. Selectively Modified anti - CD40L AB Ruplizumab full Fab C

  28. Slide 28: External Partnerships

    28 © 2024 Tonix Pharmaceuticals Holding Corp. External Partnerships Government partners providing direct funding, cost sharing or in - kind support include: • National Institutes of Health (NIH) • National Institute of Allergy and Infectious Disease (NIAID) ▪ TNX - 1800 selected for Project NextGen

  29. Slide 29: TNX-801 Live Virus Vaccine Platform

    29 © 2024 Tonix Pharmaceuticals Holding Corp. TNX - 801 Live Virus Vaccine Live virus vaccine platform with multitude of potential applications

  30. Slide 30: TNX-801: Recombinant Pox Vaccine Platform Using Live Virus Technology

    TNX - 801: Recombinant Pox Vaccine (RPV) Platform Using Live Virus Technology 30 C loned version of horsepox 1 purified from cell culture Key Differentiators © 2024 Tonix Pharmaceuticals Holding Corp. TNX - 801* (Horsepox) *TNX - 801 is in the pre - IND stage of development and has not been approved

  31. Slide 31: TNX-1800: Designed to Express the SARS-CoV-2 Spike Protein

    31 © 2024 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO TNX - 1800: Designed to Express the SARs - CoV - 2 Spike Protein TNX - 1800 (recombinant horsepox virus) is a live virus vaccine based on Tonix’s TNX - 801 that is designed to express the spike protein of the SARS - CoV - 2 v

  32. Slide 32: Broad-Spectrum Antiviral Discovery Programs

    32 © 2024 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

  33. Slide 33: Key Partnerships

    33 © 2024 Tonix Pharmaceuticals Holding Corp. TNX - 1300: COCAINE INTOXICATION Key Partnerships TNX - 1500: ALLOGRAFT REJECTION TNX - 1800 : COVID - 19 VACCINE TNX - 2900: PRADER - WILLI SYNDROME TNX - 102 SL: ACUTE STRESS DISORDER

  34. Slide 34: Team, Network, & Upcoming Milestones

    © 2024 Tonix Pharmaceuticals Holding Corp. TEAM, NETWORK, & UPCOMING MILESTONES

  35. Slide 35: Management Team

    35 © 2024 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

  36. Slide 36: Milestones: Recently Completed and Upcoming

    36 © 2024 Tonix Pharmaceuticals Holding Corp. Milestones: Recently Completed and Upcoming x Tonmya Milestones Initiate Phase 2 study of TNX - 102 SL for acute stress disorder □ 2 nd Quarter 2024 Initiate Phase 2 study of TNX - 1300 for the treatment of cocaine intoxication □ 2 nd Quarter 2024 Other

  37. Slide 37: Thank You

    © 2024 Tonix Pharmaceuticals Holding Corp. THANK YOU

  38. Slide 38: Zembrace Important Safety Information (1 of 2)

    38 © 2024 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

  39. Slide 39: Zembrace Important Safety Information (2 of 2)

    39 © 2024 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

  40. Slide 40: Tosymra Important Safety Information (1 of 2)

    40 © 2024 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

  41. Slide 41: Tosymra Important Safety Information (2 of 2)

    41 © 2024 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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