Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (November 2023)

22 slides from Tonix Pharmaceuticals's investor presentation, Nov 15, 2023

  1. Slide 1: TNX-102 SL Fibromyalgia & Long COVID

    © 2023 Tonix Pharmaceuticals Holding Corp. TNX - 102 SL Fibromyalgia & Long COVID NASDAQ: TNXP Version P0502 November 15 , 2023 (Doc 1344)

  2. Slide 2: TNX-102 SL program status and differentiators

    © 2023 Tonix Pharmaceuticals Holding Corp. TNX - 102 SL* Cyclobenzaprine HCl ( Protectic ® ) 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 complete Next Ste

  3. Slide 3: TNX-102 SL: Fibromyalgia profile and development program

    3 © 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 C

  4. Slide 4: TNX-102 SL: Fibromyalgia Program Update

    4 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: Fibromyalgia Program Update CNS PORTFOLIO Phase 3 Study, RESILIENT, will compare TNX - 102 SL 5.6 mg and placebo • First patient enrolled in April 2022 • Parallel design, double - blind, randomized placebo - controlled study, a

  5. Slide 5: Phase 3 RESILIENT Study Design

    5 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: 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 • Clinical stage complete as of N

  6. Slide 6: RALLY Study Increased Adverse Event-Related Discontinuations

    6 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: RALLY Study Increased Adverse Event - Related Discontinuations TEAE = treatment - emergent adverse event Increases in AE - Related discontinuations in RALLY study compared with RELIEF study in both placebo and TNX - 102 SL grou

  7. Slide 7: RALLY Study Impact of Missing Data on p-Values

    7 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: RALLY Study Impact of Missing Data on p - Values in RALLY MI missing data treatment attenuated p - values in RALLY • At the current time, we expect MI will be part of the statistical analysis for the RESILIENT trial FIQR = Fibr

  8. Slide 8: TNX-102 SL: Fibromyalgia-Type Long COVID (PASC)

    8 © 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 pa

  9. Slide 9: About Fibromyalgia-Type Long COVID

    9 © 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 Memo

  10. Slide 10: Phase 2 PREVAIL Study Design

    10 © 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

  11. Slide 11: Phase 2 PREVAIL Topline Results

    11 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: Phase 2 PREVAIL Topline Results 1 Did not meet the primary endpoint of multi - site pain reduction at Week 14 However, f indings fulfill the objectives of proof - of - concept study, supporting the decision to advance the prog

  12. Slide 12: Next Steps

    12 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO 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 encephalomyelitis

  13. Slide 13: Acute Stress Reaction / Acute Stress Disorder

    13 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CNS PORTFOLIO Acute Stress Reaction (ASR)/ Acute Stress Disorder (ASD) ASR/ASD are acute stress conditions resulting from trauma which c an affect both civilian and military populations. Large unmet need: • According to National Center for

  14. Slide 14: ASR/ASD Program Status

    14 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO ASR/ASD Program Status Status: Expect to start Phase 2 in 1Q 2024 Phase 2 Trial Funded by DoD grant to University of North Carolina (UNC) • UNC Institute for Trauma Recovery awarded a $3M grant from the Department of Defense (DoD) • OASIS t

  15. Slide 15: Phase 2 OASIS Study Design

    15 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: Phase 2 OASIS Study Design General s tudy c haracteristics: • Randomized, double - blind, placebo - controlle d study in Acute Stress Reaction (ASR) / Acute Stress Disorder (ASD) • The proposed O ptimizing A cute S tress react

  16. Slide 16: Thank You

    © 2023 Tonix Pharmaceuticals Holding Corp. THANK YOU

  17. Slide 17: Appendix

    © 2023 Tonix Pharmaceuticals Holding Corp. APPENDIX

  18. Slide 18: Chronic Overlapping Pain Conditions Share Brain Processes

    18 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Chronic Overlapping Pain Conditions (COPC) Believed to Result from Shared Brain Processes • COPC is a set of disorders that coaggregate ; these disorders can include but are not limited to 1,2 : • Temporomandibular disorder • Fibromyalgia •

  19. Slide 19: Role of Infections in Triggering Fibromyalgia or CFS-Like Illnesses

    19 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Role of Infections in Triggering Fibromyalgia or Chronic fatigue (CFS) - Like Illnesses Infection initiates an autoreactive process, which affects several functions, including brain and energy metabolism 2 - 7 • Infections can trigger any o

  20. Slide 20: New Classification for Central Pain: Nociplastic Pain

    20 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO New Classification for Central Pain: Nociplastic Pain 1 Nociplastic pain Nociceptive pain Neuropathic pain Pain due to the activation of nociceptors that arises from actual or threatened damage to non - neural tissue Pain that arises from a

  21. Slide 21: Central Sensitization in Nociplastic Pain Syndromes

    21 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Central Sensitization (CS) A Feature of Many Nociplastic Pain Syndromes • CS is caused by amplified neural signaling in CNS pain circuits 1 - 3 • Patients with CS perceive higher pain to a slightly noxious stimuli than in non - CS individua

  22. Slide 22: Central Sensitization in a Range of Diseases and Conditions

    22 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Central Sensitization (CS) Can Occur in a Range of Diseases and Conditions Degree of central sensitization Nijs J, et al. Lancet . 2021;3(5):e383 - e392.

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