Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — BIO International 2016

19 slides from Tonix Pharmaceuticals's conference presentation, Jun 7, 2016

  1. Slide 1: 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 7, 2016 BIO International , San Francisco, June 7, 2016 Version 0019 6 - 7 - 16 © 2016 Tonix Pharmaceuticals Holding Corp

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

    2 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 Litigation Reform Act of 1995 . These statements m

  3. Slide 3: Investment Thesis for Tonix Pharmaceuticals

    3 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 markets • Clinically validated in fibromyalg

  4. Slide 4: Cyclobenzaprine: Potential To Improve Sleep Quality

    4 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 (serotonin and norepinephrine transporters) • Prof

  5. Slide 5: Innovative and Differentiated: A low-dose sublingual formulation of CBP

    5 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 bioavailability • Avoids first - pass metabolism, reduci

  6. Slide 6: Intellectual Property Portfolio

    6 Intellectual Property 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 2033 Method - of - use • Fibromyalgia: patents

  7. Slide 7: BestFit Study - Phase 2b in Fibromyalgia

    7 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 © 2016 Tonix Pharmaceuticals Holding Corp • Randomized

  8. Slide 8: BestFit Key Clinical Results

    8 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 -6 -4 -2 0 Reduction in Sleep Disturbances PR

  9. Slide 9: BestFit Safety and Tolerability Profile

    9 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 reactions • Transient tongue numbness (44% TNX -

  10. Slide 10: AFFIRM Study - Phase 3 in Fibromyalgia

    10 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, placebo - controlled study in fibromyalgia •

  11. Slide 11: Targeting Military-related PTSD

    11 Targeting Military - related PTSD 11 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.S. military populatio n Sertraline: negat

  12. Slide 12: The AtEase Study - Phase 2 in PTSD

    12 The 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 : Difference in Clinician - Administered PTSD Scale ( CAPS - 5 ) score between TNX - 102 SL 2.8 mg and p

  13. Slide 13: AtEase Study Key Demographics

    13 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 with U.S. military distribution • Similar bas

  14. Slide 14: AtEase Study Results

    14 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 - effect model repeated measures with mul

  15. Slide 15: AtEase Study Results

    15 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, comparing TNX - 102 SL 2.8 mg to placebo, mi

  16. Slide 16: AtEase Study Results Adverse Events

    16 AtEase Study Results Adverse Events (≥5% rate in any group) * safety population © 2016 Tonix Pharmaceuticals Holding Corp 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

  17. Slide 17: AtEase Study Conclusions

    17 AtEase Study Conclusions • This is the first large, multicenter trial that demonstrated efficacy in a population with military - related PTSD • Male predominant (93%) • Low incidence of co - morbid FM (7%) • Low incidence of current major depression (14%) • Early effects on sleep and hyperarousal

  18. Slide 18: Summary: Tonix Pharmaceuticals

    18 Summary: 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 markets • Clinically validated in fibromyalgia (FM) • Co

  19. Slide 19: Thank You!

    19 Thank You! © 2016 Tonix Pharmaceuticals Holding Corp

Tonix Pharmaceuticals Holding — BIO International 2016 on 6ix