Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (June 2016)

32 slides from Tonix Pharmaceuticals's investor presentation, Jun 28, 2016

  1. Slide 1: Update: Topline Results With TNX-102 SL in Post-Traumatic Stress Disorder

    1 UPDATE Topline Results With TNX - 102 SL In Post - Traumatic Stress Disorder June 2016 Version 0021 6 - 21 - 16 Investor Presentation - June 2016 © 2016 Tonix Pharmaceuticals Holding Corp

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

    2 © 2016 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 Litigati

  3. Slide 3: Investment Thesis for Tonix Pharmaceuticals

    3 © 2016 Tonix Pharmaceuticals Holding Corp Investment Thesis for Tonix Pharmaceuticals UPDATE Differentiated Late - Stage Program Commercially Attractive Markets • TNX - 102 SL (cyclobenzaprine sublingual tablets), 2.8 mg • Differentiated with unique attributes that address unmet needs of target ma

  4. Slide 4: Therapeutic Approach Used to Develop TNX-102 SL

    4 © 2016 Tonix Pharmaceuticals Holding Corp Therapeutic Approach Used to Develop TNX - 102 SL Sleep quality: • How refreshing or satisfying was his or her sleep? • Emotional , mental, and physical rejuvenation to feel well and focused • Not always correlated with sleep quantity ( ~ insomnia/sedative

  5. Slide 5: Relevance of Sleep Disturbances for FM and PTSD

    5 © 2016 Tonix Pharmaceuticals Holding Corp Relevance of Sleep Disturbances for FM and PTSD Sleep disturbances: x C ore symptoms of FM and PTSD • Disturbances may be qualitatively different x Believed to have a role in the pathophysiology of both disorders om Sleep As a Core Symptom P athophysiology

  6. Slide 6: Cyclobenzaprine: Potential to Improve Sleep Quality

    6 © 2016 Tonix Pharmaceuticals Holding Corp CBP targets receptors with potential therapeutic effects for sleep disturbances • Multimodal: high affinity, relative selectivity and functional antagonism • 5 - HT 2A • a 1 - adrenergic • histamine H 1 • 6 - 7 fold lower affinity for SERT and NET (seroton

  7. Slide 7: Innovative and Differentiated: A low-dose sublingual formulation of CBP

    7 © 2016 Tonix Pharmaceuticals Holding Corp Designed to take advantage of targeted high affinity receptors of CBP Differentiated from immediate release oral CBP : • Formulated for transmucosal absorption to allow sublingual administration at bedtime • Rapid systemic exposure • Improved bioavailabili

  8. Slide 8: Key Product Features

    8 © 2016 Tonix Pharmaceuticals Holding Corp TNX - 102 SL : Novel, Proprietary Formulation API Cyclobenzaprine HCl Route of Administration Sublingual - rapid absorption - avoids first - pass metabolism Formulation Protectic TM - protective eutectic formulation - intellectual property rights - stabili

  9. Slide 9: 2.8 mg PK Profile relative to oral IR CBP

    9 © 2016 Tonix Pharmaceuticals Holding Corp TNX - 102 SL 2.8 mg PK Profile relative to 5 mg oral IR CBP: 0 500 1000 1500 2000 2500 3000 3500 4000 0 4 8 12 16 20 24 Concentration (ng/mL) TNX - 102 SL 2.8 mg Oral IR CBP 5 mg x More prominent from hours 8 - 24 ('daytime') x Reduced exposure to nCBP by

  10. Slide 10: Intellectual Property

    10 © 2016 Tonix Pharmaceuticals Holding Corp Intellectual P roperty Portfolio of international patents filed under the Patent Cooperation Treaty (PCT ) C omposition - of - matter (eutectic) • Patents filed • Protection expected to 2034 Pharmacokinetics (PK) • Patents filed • Protection expected to 2

  11. Slide 11: BestFit Study - Phase 2b in Fibromyalgia

    11 © 2016 Tonix Pharmaceuticals Holding Corp BestFit Study - TNX - 102 SL Phase 2 in Fibromyalgia Placebo once - daily at bedtime 12 weeks TNX - 102 SL once - daily at bedtime N = 102 N = 103 2.8 mg open - label extension 1. FDA - accepted primary endpoint in current Phase 3 AFFIRM study • Randomize

  12. Slide 12: BestFit Key Clinical Results

    12 © 2016 Tonix Pharmaceuticals Holding Corp BestFit Key Clinical Results 20.6% 34.0% 0% 10% 20% 30% 40% Pain Relief 30 % Responder Rate Based on Pain NRS Placebo n=102 TNX - 102 SL n=103 P =.033 Logistic regression NRS=Numeric Rating Scale Placebo n =85 TNX - 102 SL n=89 P =.005 - 5.1 - 9.0 -10 -8

  13. Slide 13: BestFit Safety and Tolerability Profile

    13 © 2016 Tonix Pharmaceuticals Holding Corp BestFit Safety and Tolerability Profile No serious adverse events (SAE) reported with TNX - 102 SL Systemic adverse events reported by at least 3.0% of the total BESTFIT study population: Most frequent local adverse events were administration site reactio

  14. Slide 14: AFFIRM Study - Phase 3 in Fibromyalgia

    14 © 2016 Tonix Pharmaceuticals Holding Corp FULLY ENROLLED - Topline Expected 3Q 2016 • Second Phase 3 Study (“REAFFIRM”) expected to begin in July 2016 - Expected to be similar to AFFIRM in design and sample size AFFIRM Study - TNX - 102 SL Phase 3 in Fibromyalgia • Randomized, double - blind, pla

  15. Slide 15: Targeting Military-related PTSD

    15 © 2016 Tonix Pharmaceuticals Holding Corp Targeting Military - related PTSD 15 1. Friedman et al., 2007, 2. Zoloft Package Insert, August, 2014, 3. Paxil Package Insert, June, 2014 Military - related PTSD not well - served by existing FDA - approved therapies • No treatment response observed in U

  16. Slide 16: AtEase Study - Phase 2 in PTSD

    16 © 2016 Tonix Pharmaceuticals Holding Corp AtEase Study - TNX - 102 SL Phase 2 in PTSD • Randomized, double - blind, placebo - controlled trial in military - related PTSD • N=231 ; 24 U.S. clinical sites • Primary efficacy endpoint: D ifference in Clinician - Administered PTSD Scale ( CAPS - 5 ) s

  17. Slide 17: AtEase Study Key Demographics

    17 © 2016 Tonix Pharmaceuticals Holding Corp AtEase Study Key Demographics / Characteristics of AtEase • 93% of the sample was male • 98% had trauma during military service and were deployed on average 2.3 times • Mean time since index trauma was 7 years • Race and ethnicity generally consistent wit

  18. Slide 18: AtEase Study - Index Trauma

    18 AtEase Study - Index Trauma Proprietary and Confidential © 2016 Tonix Pharmaceuticals Holding Corp Index Traumas During Military Service Related to Dx of PTSD Patient Count Being involved in an IED explosion or suicide bombing 35 Being attacked or ambushed 33 Witnessing death or injury of fellow

  19. Slide 19: AtEase Study Results

    19 © 2016 Tonix Pharmaceuticals Holding Corp AtEase Study Results -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 placebo and TNX - 102 SL 2.8 mg, by MMRM with MI, mixed

  20. Slide 20: AtEase Study Results

    20 © 2016 Tonix Pharmaceuticals Holding Corp AtEase Study Results -7 -6 -5 -4 -3 -2 -1 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 * * * * * * LS Mean Change * p<0.05, comparing TNX - 102 SL 5.6 mg to placebo, mixed - effect model repeated measures * p<0.05, co

  21. Slide 21: AtEase Study Results

    21 © 2016 Tonix Pharmaceuticals Holding Corp AtEase Study Results 44.6% 53.3% 63.3% 0% 10% 20% 30% 40% 50% 60% 70% Placebo TNX-102 SL 2.8 mg TNX-102 SL 5.6 mg * *p=0.041 , Logistic regression comparing placebo and TNX - 102 SL 5.6 mg Responders are those rated as “much improved” or “very much improv

  22. Slide 22: AtEase Study Results

    22 © 2016 Tonix Pharmaceuticals Holding Corp AtEase Study Results Sheehan Disability Scale – Work/School & Social/Leisure Domains 1.5 2 2.5 3 3.5 4 4.5 5 5.5 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 2.5 3 3.5 4 4.5 5 5.5 6 6.5 7 7.5 Wk 0 Wk 2 Wk 4 Wk 6 Wk 8 Wk

  23. Slide 23: AtEase Study Results

    23 © 2016 Tonix Pharmaceuticals Holding Corp AtEase Study Results Adverse Events (≥5% rate in any group) Preferred Term Placebo N=94* TNX - 102 SL 2.8 mg N=93* TNX - 102 SL 5.6 mg N=50* Overall N=237* Local Administration Site Conditions Hypoaesthesia oral 2 ( 2.1%) 36 (38.7%) 18 (36.0%) 54 (37.8%)

  24. Slide 24: AtEase Study Summary of Results

    24 © 2016 Tonix Pharmaceuticals Holding Corp AtEase Study Summary of Results Presented at American Society of Clinical Psychopharmacology, May 31, 2016 • Recruited a population with severe military - related PTSD , almost exclusively combat traumas incurred during OIF/OEF/OND deployments: • Predomin

  25. Slide 25: AtEase Study Conclusions

    25 © 2016 Tonix Pharmaceuticals Holding Corp AtEase Study Conclusions • This is the first multicenter randomized clinical trial of any medication that has demonstrated efficacy in a population with military - related PTSD • Early effects on sleep and hyperarousal are consistent with the mechanistic

  26. Slide 26: Value Proposition

    26 © 2016 Tonix Pharmaceuticals Holding Corp TNX - 102 SL Value Proposition Differentiated • Innovative sublingual tablet • Rapid bedtime absorption • Peak concentration during sleep period (first 8 hours) • Reduced exposure to long - lived active metabolite Efficacy Results • FM (Phase 2b); pain re

  27. Slide 27: Fibromyalgia: Market Characteristics

    27 © 2016 Tonix Pharmaceuticals Holding Corp Fibromyalgia: Market Characteristics [CATEGORY NAME] 50% [VALUE] Drug Treated 85% 3 [VALUE] [CATEGORY NAME] 15% 3 [VALUE] Prevalence Population ~5.4 million 1 1. Queiroz , 2013 prevalence rate of 2.2% of adult population - adjusted for estimated U.S. adul

  28. Slide 28: PTSD - Market Summary

    28 © 2016 Tonix Pharmaceuticals Holding Corp PTSD - Market Summary [CATEGORY NAME] [VALUE] [PERCENTAG E] Rx [VALUE] [PERCENTAG E] No Rx [VALUE] [PERCENTAG E] Rx [VALUE] [PERCENTAG E] No Rx [VALUE] [PERCENTAG E] Prevalence Population ~8.4 million 1 1. Kessler, et al., 2005; Prevalence rate of 3.5% ap

  29. Slide 29: Financial Overview

    29 © 2016 Tonix Pharmaceuticals Holding Corp Financial overview NASDAQ: TNXP Cash, cash equivalents, and marketable securities reported at March 31, 2016 Net proceeds from underwritten stock offering in 2Q16 $ 27.5 million $9.1 million Shares outstanding (June 21, 2016) 25.1 million

  30. Slide 30: Management Team

    30 © 2016 Tonix Pharmaceuticals Holding Corp Management team Seth Lederman, MD President & CEO Jessica Edgar Morris EVP, Administration Bruce Daugherty, PhD, MBA Chief Scientific Officer Ronald Notvest, PhD EVP, Commercial Planning & Development Gregory Sullivan, MD Chief Medical Officer Bradley Sae

  31. Slide 31: Board of Directors

    31 © 2016 Tonix Pharmaceuticals Holding Corp Board of directors Seth Lederman, MD Chairman Ernest Mario, PhD ALZA, Glaxo, Reliant Pharma John Rhodes NYSERDA, NRDC, Booz Allen Hamilton Samuel Saks, MD Jazz Pharma, ALZA, Johnson & Johnson Charles Mather BTIG, Janney, Jefferies, Cowen, Smith Barney Stu

  32. Slide 32: Thank You!

    32 © 2016 Tonix Pharmaceuticals Holding Corp Thank You!

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