Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — American Society of Clinical Psychopharmacology Annual Meeting 2017

18 slides from Tonix Pharmaceuticals's conference presentation, May 30, 2017

  1. Slide 1: TNX-102 SL for Military-Related PTSD: Retrospective Analyses of Mediators and Moderators

    © 2017 Tonix Pharmaceuticals Holding Corp. Presented by Gregory Sullivan, MD at American Society of Clinical Psychopharmacology Annual Meeting, Miami, FL May 30, 2017 Bedtime Sublingual Transmucosal Cyclobenzaprine (TNX - 102 SL) for the Treatment of Military - Related PTSD: Retrospective Analyses o

  2. Slide 2: What is Military-Related PTSD and Why Study It?

    © 2017 Tonix Pharmaceuticals Holding Corp. 2 What is Military - Related PTSD and Why Study It? » Proposed indication for TNX - 102 SL* is for the treatment of posttraumatic stress disorder (PTSD): » Affects 8.6 million U.S. adults 1 » Definition of military - related PTSD: » Any PTSD that has develo

  3. Slide 3: What is TNX-102 SL?

    © 2017 Tonix Pharmaceuticals Holding Corp. 3 What is TNX - 102 SL? » TNX - 102 SL is a patented 1 sublingual eutectic formulation of cyclobenzaprine (CBP) for transmucosal absorption » Tricyclic molecule with high affinity for target receptors considered to play key roles in sleep physiology and noc

  4. Slide 4: Rationale for Targeting of Sleep for Treatment of PTSD

    © 2017 Tonix Pharmaceuticals Holding Corp. 4 Rationale for Targeting of Sleep for Treatment of PTSD » PTSD is a disorder of recovery » Most people exposed to an extreme trauma recover in a few weeks » New learning, e.g. extinction, and memory processing are essential to recovery » In PTSD, memory pr

  5. Slide 5: Phase 2 AtEase Study in Military-Related PTSD

    © 2017 Tonix Pharmaceuticals Holding Corp. 5 Phase 2 AtEase Study in Military - Related PTSD » Randomized, double - blind, placebo - controlled trial in military - related PTSD » Efficacy analysis from 231 patients; 24 U.S. clinical sites » Enrolled patients with baseline CAPS - 5 score ≥ 29 » Prima

  6. Slide 6: AtEase Study Results: Primary and Sensitivity Analyses of Change from Baseline

    © 2017 Tonix Pharmaceuticals Holding Corp. 6 AtEase Study Results: Primary and Sensitivity Analyses of CAPS - 5 Change from Baseline » TNX - 102 SL 2.8 mg dose (N=90) had a greater CAPS - 5 change from baseline at Week 2 (MMRM, p=0.040) and Week 4 (MMRM, p=0.030) but did not achieve a significantly

  7. Slide 7: AtEase Study Results: Primary Endpoint Total Score by MMRM with MI

    © 2017 Tonix Pharmaceuticals Holding Corp. 7 AtEase Study Results: Primary Endpoint CAPS - 5 Total Score by MMRM with MI -25 -20 -15 -10 -5 0 Wk 0 Wk 2 Wk 4 Wk 6 Wk 8 Wk 10 Wk 12 Placebo TNX-102 SL 2.8 mg TNX-102 SL 5.6 mg * * p=0.031, comparing placebo and TNX - 102 SL 5.6 mg, * p<0.05, comparing p

  8. Slide 8: AtEase Study Results: Safety and Tolerability

    © 2017 Tonix Pharmaceuticals Holding Corp. 8 AtEase Study Results: Safety and Tolerability » Trial Completion Rates: 73% Placebo; 79% TNX - 102 SL 2.8 mg; 84% TNX - 102 SL 5.6 mg » Systemic adverse events (AEs) and local administration site reactions occurring at ≥5% rate in either TNX - 102 SL grou

  9. Slide 9: Sleep as a Mediator of PTSD Treatment Response

    © 2017 Tonix Pharmaceuticals Holding Corp. 9 Sleep as a Mediator of PTSD Treatment Response » Mechanism of action of TNX - 102 SL is hypothesized to be through improvement in sleep quality » Sleep responded early in treatment with TNX - 102 SL, by Week 2 on CAPS - 5 sleep disturbance (SD) item » PRO

  10. Slide 10: Sleep as Mediator of PTSD Treatment Response

    © 2017 Tonix Pharmaceuticals Holding Corp. 10 Sleep as Mediator of PTSD Treatment Response Week 4 Sleep Change by PROMIS SD v. Week 12 CAPS - 5 Response* -50 -40 -30 -20 -10 0 10 20 -40 -30 -20 -10 0 10 20 30 CFB in Total CAP - 5 (minus E6) at Week 12 CFB in PROMIS Sleep Disturbance T - Score at Wee

  11. Slide 11: Summary of Hypothesized Mechanism of Action in PTSD Recovery

    © 2017 Tonix Pharmaceuticals Holding Corp. 11 Summary of Hypothesized Mechanism of Action in PTSD Recovery (over weeks) Diagram adapted from Pace - Schott et al. Biol Mood Anxiety Disord 2015;5:3 » Recovery is a learning process, e.g. depends on extinction learning » Extinction learning occurs in th

  12. Slide 12: Assessing Entry Threshold in AtEase

    © 2017 Tonix Pharmaceuticals Holding Corp. 12 Assessing CAPS - 5 Entry Threshold in AtEase » Score of ≥29 on CAPS - 5 (20 items) required at screening & baseline » >50 on prior versions of CAPS (17 items) typical in previous drug registration trials » Extrapolation from prior versions of CAPS: ((50/

  13. Slide 13: AtEase Retrospective Analysis: Effect Sizes for Total and Cluster Scores

    © 2017 Tonix Pharmaceuticals Holding Corp. 13 0.53 0.46 0.012 0.39 0.52 0 0.1 0.2 0.3 0.4 0.5 0.6 Effect Size AtEase Retrospective Analysis: Effect Sizes for Total CAPS - 5 and Cluster Scores * MMRM, mixed - effects model repeated measures, p<0.05 » Effect sizes calculated for total CAPS - 5 and clu

  14. Slide 14: AtEase Retrospective Analysis: Remission from PTSD

    © 2017 Tonix Pharmaceuticals Holding Corp. 14 AtEase Study Retrospective Analysis: Remission from PTSD (CAPS - 5 Baseline ≥33 Subgroup) Asterisks and hashmark represent pairwise comparisons, TNX - 102 SL group v. placebo, logistic regression * p<0.05; # p=0.060 » Optimal outcome of treatment is achi

  15. Slide 15: AtEase Retrospective Analysis: Sustained Remission in Baseline ≥33 Subgroup

    © 2017 Tonix Pharmaceuticals Holding Corp. 15 AtEase Study Retrospective Analysis: Sustained Remission in CAPS - 5 Baseline ≥33 Subgroup 5.20% 14.30% 21.10% 0% 5% 10% 15% 20% 25% 30% Weeks 8 & 12 Percent in Remission Placebo (N=77) TNX-102 SL 2.8 mg (N=70) TNX-102 SL 5.6 mg (N=38) # * Remission = Lo

  16. Slide 16: Phase 3 HONOR Study in PTSD Enrolling

    © 2017 Tonix Pharmaceuticals Holding Corp. 16 Phase 3 HONOR Study in PTSD Enrolling » General s tudy c haracteristics: » Randomized, double - blind, placebo - controlled, entrance CAPS - 5 ≥ 33 » One unblinded interim analys i s (IA) by an independent data monitoring committee at 50% randomized » IA

  17. Slide 17: Conclusions

    © 2017 Tonix Pharmaceuticals Holding Corp. 17 Conclusions » Phase 2 clinical investigation established that TNX - 102 SL 5.6 mg is the potential efficacious and safe dose to treat PTSD in a military - related PTSD population (TNX - 102 SL 5.6 mg, N=49 v. placebo, N=92) » Established CAPS - 5 ≥33 as

  18. Slide 18: Thank you!

    © 2017 Tonix Pharmaceuticals Holding Corp. Thank you ! NASDAQ: TNXP

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