Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Technical Presentation (September 2023)

33 slides from Tonix Pharmaceuticals's technical presentation, Sep 21, 2023

  1. Slide 1: TNX-102 SL for Long COVID: Results of the PREVAIL Trial

    © 2023 Tonix Pharmaceuticals Holding Corp. TNX - 102 SL FOR LONG COVID RESULTS OF THE TNX - CY - PA201 ‘PREVAIL’ TRIAL BRIEFING DECK Version P0487 September 20, 2023 (Doc 1319 )

  2. Slide 2: Pipeline: Key Clinical Development Programs

    2 © 2023 Tonix Pharmaceuticals Holding Corp. Pipeline: Key Clinical Development Programs Status/Next Milestone Indication Candidates* Mid - Phase 3 – enrollment complete Phase 2 – Topline Data Announced 5 Sept 2023 Fibromyalgia (FM) Long COVID (PASC 2 ) TNX - 102 SL 1 Mid - Phase 2, Targeted 3Q 2023

  3. Slide 3: Investigational Product TNX-102 SL

    © 2023 Tonix Pharmaceuticals Holding Corp. INVESTIGATIONAL PRODUCT 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) enro

  4. Slide 4: Fibromyalgia-Type Long COVID

    4 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fibromyalgia - Type Long COVID • Long COVID is a heterogeneous condition that displays elements of nociplastic pain 1 in many individuals, who experience otherwise unexplained symptoms 2 - 4 Symptoms (multi - site pain, fatigue, sleep disord

  5. Slide 5: Development Program: TNX-102 SL in Fibromyalgia-Type Long COVID

    5 © 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

  6. Slide 6: TNX-102 SL Phase 2 Study Design

    6 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: Phase 2 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 Endpoint: •

  7. Slide 7: Demographics and Baseline Characteristics

    7 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO 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 (%) 25 (80.

  8. Slide 8: Topline Results

    8 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO 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, but did

  9. Slide 9: Primary Endpoint: Weekly Summary of Daily Pain Scores

    9 © 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 Long

  10. Slide 10: Weekly Summary of Daily Sleep Scores

    10 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO 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 scores for T

  11. Slide 11: PROMIS Sleep Disturbance

    11 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO 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 -2 0 Wee

  12. Slide 12: PROMIS Fatigue Score

    12 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO 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 Clinical Epi

  13. Slide 13: PROMIS Cognitive Function - Abilities

    13 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROMIS Cognitive Function - Abilities 0 2 4 6 8 Week 0 Week 2 Week 6 Week 10 Week 14 LS Mean Difference (SE) in PROMIS Cognitive Function Study Week PROMIS Cognitive Function Change from Baseline for TNX - 102 SL versus Placebo Placebo (N=3

  14. Slide 14: Patient Global Impression of Change Responder Analysis

    14 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Patient Global Impression of Change Responder Analysis ( Much or Very 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% 30% 35% 40% 45% 50%

  15. Slide 15: Safety and Most Common Adverse Events

    15 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Safety and Most Common 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 Glossodyni

  16. Slide 16: Next Steps

    16 © 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

  17. Slide 17: Thank You

    © 2023 Tonix Pharmaceuticals Holding Corp. THANK YOU

  18. Slide 18: Appendix: About Long COVID and Commonalities with Fibromyalgia, CFS/ME

    © 2023 Tonix Pharmaceuticals Holding Corp. APPENDIX: ABOUT LONG COVID AND COMMONALITIES WITH FIBROMYALGIA, CFS/ME, AND POST - VIRAL SYNDROMES 18

  19. Slide 19: Chronic Overlapping Pain Conditions from Shared Brain Processes

    19 © 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 •

  20. Slide 20: Role of Infections in Triggering Fibromyalgia or CFS-Like Illnesses

    20 © 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

  21. Slide 21: Potential Increase in Myalgia Following the COVID Pandemic

    21 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO POTENTIAL INCREASE IN MYALGIA FOLLOWING THE COVID - 19 PANDEMIC The specific causes may be due to: Chronic pain increase due to COVID - 19 could be nociplastic , neuropathic, or nociceptive Chronic pain newly triggered in individuals withou

  22. Slide 22: New Classification for Central Pain: Nociplastic Pain

    22 © 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

  23. Slide 23: Central Sensitization a Feature of Nociplastic Pain Syndromes

    23 © 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

  24. Slide 24: Central Sensitization Can Occur in a Range of Conditions

    24 © 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.

  25. Slide 25: Timeline of Long COVID After Acute COVID

    25 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Timeline of Long COVID After Acute COVID - 19 Post - Viral Syndrome 1 - 3 Week - 2 Week - 1 Week 1 Week 2 Week 3 Week 4 6 months Detection unlikely PCR positive PCR negative Acute COVID - 19 Long COVID Viral load Nasopharyngeal Respiratory

  26. Slide 26: Prevalence of Long COVID

    26 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Prevalence of Long COVID ~30% of Recovered SARS - CoV - 2 Patients after 6 Months Long COVID (PASC) is more prevalent among patients 1,2 : • Requiring hospitalization (93% vs 23% for those not requiring hospitalization) • With severe sympto

  27. Slide 27: Rate of Central Sensitization in Long COVID

    27 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Rate of Central Sensitization (CS) in Long COVID survey CS Symptoms reported in 70% 1 70% 30% Long COVID with CSI ≥40/100 Long COVID with CSI <40/100 491 total participants 1 Goudman , L, et al. J of Clin Med . 2021;10(23):5594. 2 CSI = Cen

  28. Slide 28: Long COVID Patients in TriNetX Study

    28 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Long COVID Patients in TriNetX Study 1 Retrospective Observational Database Study 1 Harris, H, et al. Tonix data on file. 2022. 2 TriNetX Analytics 3 Topaloglu, U, and Palchuk , MB. JCO clinical cancer informatics . 2018;2:1 - 10. TriNetX D

  29. Slide 29: Fibromyalgia-like Symptoms in Over 40% of Long COVID Patients

    29 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO L ong COVID P atients in T riNetX study 1 F ibromyalgia - like Symptoms (Multi - Site Pain) in Over 40% of Patients 1,2 79% 13% 6% 2% 52,322 total Long COVID patients 21,694 total FM - like Long COVID patients 1 Harris, H, et al. Tonix data

  30. Slide 30: Recorded Medication Use, Days 91-180

    30 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO L ong COVID Patients in TriNetX Study 1 Recorded Medication Use, Days 91 - 180 15.0% 18.8% 39.8% 28.8% 34.0% 29.9% 25.9% 39.0% 35.8% 35.8% 50.1% 59.2% 43.1% 51.1% 62.8% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Patients with compounding n

  31. Slide 31: Rate of Opioid Use in Long COVID Patients

    31 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO 18.8% 34.0% 39.0% 50.1% 51.1% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Percent of Patients taking Opioids Rate of Opioid Use in Long COVID Patients Potential Health Concern • In only a few days some people can develop a physical dependen

  32. Slide 32: Significant Financial Impact of Long COVID

    32 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Significant Financial Impact of Long COVID for Households and Economies 25% of Long COVID patients are unable to return to work 1 Over 250,000 Quality Adjusted Life - Years (QUALYS) will be lost due to Long COVID in the UK 2 $23.3 billion i

  33. Slide 33: Long COVID Presidential Memorandum

    33 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Long COVID Presidential Memorandum President Biden – April 5, 2022 1 Policy • Commits to redoubling efforts to address the long - term effects of COVID - 19 Organizing Government Wide Response • Harnesses the full potential of the Federal G

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