Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Biotech Showcase 2020

33 slides from Tonix Pharmaceuticals's conference presentation, Jan 13, 2020

  1. Slide 1: Investor Presentation – Biotech Showcase 2020

    © 2020 Tonix Pharmaceuticals Holding Corp. 1 Biotech Showcase 2020 Version P0217 1 - 13 - 20 (Doc 0584) Investor Presentation

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

    © 2020 Tonix Pharmaceuticals Holding Corp. 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 Litigat

  3. Slide 3: Tonix Pharmaceuticals: Lead Programs In Phase 3

    © 2020 Tonix Pharmaceuticals Holding Corp. 3 Tonix Pharmaceuticals: Lead Programs In Phase 3 clinical development of TNX - 102 SL 1 for two different conditions: • Posttraumatic Stress Disorder (PTSD) – Phase 3 study enrolling • Fibromyalgia – Phase 3 study enrolling PTSD milestones ( Phase 3 RECOVE

  4. Slide 4: Novel sublingual formulation of cyclobenzaprine

    © 2020 Tonix Pharmaceuticals Holding Corp. 4 TNX - 102 SL TNX - 102 SL • Novel sublingual formulation of cyclobenzaprine HCl 1 designed for long - term daily use at bedtime • Rapid absorption • Transmucosal absorption bypasses first pass liver metabolism • Dynamic pharmacokinetic profile with increa

  5. Slide 5: Potential Therapeutic Advantages of Cyclobenzaprine

    © 2020 Tonix Pharmaceuticals Holding Corp. 5 Potential Therapeutic Advantages of TNX - 102 SL Cyclobenzaprine, active ingredient of TNX - 102 SL, is NEITHER a benzodiazepine nor a narcotic • Does NOT interact with the same receptors as traditional hypnotic sleep drugs associated with retrograde amne

  6. Slide 6: Potential Role of Sleep Quality in PTSD and Fibromyalgia

    © 2020 Tonix Pharmaceuticals Holding Corp. 6 Potential Role of Sleep Quality in PTSD and Fibromyalgia PTSD • The brain naturally processes memories during sleep • PTSD sufferers’ emotionally charged memories disturb sleep and disrupt the natural processing of memories during sleep • TNX - 102 SL is

  7. Slide 7: Intellectual Property – Patent Protection expected until 2035

    © 2020 Tonix Pharmaceuticals Holding Corp. 7 TNX - 102 SL Intellectual Property – Patent Protection expected until 2035 Composition of matter (eutectic): protection expected to 2034/2035 10 patents issued worldwide; 35 patent applications pending Composition of matter (sublingual): protection expect

  8. Slide 8: Prevalence of PTSD Among Civilians and Veterans

    © 2020 Tonix Pharmaceuticals Holding Corp. 8 Prevalence of PTSD Among Civilians and Veterans 1 Goldstein et al., 2016 (adjusted for 2019) ; 2 Norris, PTSD Res Quar. 2013; 3 Analysis of VA Health Care Utilization among Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn Vete r

  9. Slide 9: Unmet Need for Effective and Safe Therapies for Treatment of PTSD

    © 2020 Tonix Pharmaceuticals Holding Corp. 9 Unmet Need for Effective and Safe Therapies for Treatment of PTSD No FDA - approved products for PTSD since Pfizer’s Zoloft ® (sertraline) in 1999 and GSK’s Paxil ® (paroxetine) in 2001 • Neither has shown efficacy in military - related PTSD • Side effect

  10. Slide 10: PTSD Is a Memory Processing Disorder

    © 2020 Tonix Pharmaceuticals Holding Corp. 10 • The central feature of PTSD is the reliving of trauma through intrusive and vivid recollections, nightmares, or flashbacks 1 • Re - experiencing intrusive symptoms are believed to be caused by memory processing impairments 2 PTSD Is a Memory Processing

  11. Slide 11: Memories are Processed During Sleep

    © 2020 Tonix Pharmaceuticals Holding Corp. 11 Memories are Processed During Sleep • Memory consolidation occurs primarily during sleep 1,2 • The main brain regions involved in emotional memory processing are the prefrontal cortex, amygdala, and hippocampus 2 - 4 1. Hanert A, et al. J Neurosci . 2017

  12. Slide 12: In PTSD Trauma Memories Are Not Consolidated

    © 2020 Tonix Pharmaceuticals Holding Corp. 12 In PTSD Trauma Memories Are Not Consolidated • Crucial brain regions and circuits become impaired in PTSD, so emotional memories are not properly consolidated 1 - 4 Memory Processing in PTSD • Memory traces are not properly processed, and remain “trapped

  13. Slide 13: Sleep Disruption Is a Core Feature of PTSD

    © 2020 Tonix Pharmaceuticals Holding Corp. 13 Sleep Disruption Is a Core Feature of PTSD • About 70% of individuals with PTSD report sleep problems 1 1. Brownlow JA, et al. Curr Psychiatry Rep. 2015;17(6):41. 2. Lipinksa M, et al. J Sleep Res. 2014;23(3):309 - 317. Sleep Problems in PTSD • Abnormali

  14. Slide 14: Phase 2 P201/AtEase Study in Military-Related PTSD

    © 2020 Tonix Pharmaceuticals Holding Corp. 14 Phase 2 P201/AtEase 1 Study in Military - Related PTSD Primary e ndpoint CAPS - 5 2 : • Mean change from baseline at W eek 12 (TNX - 102 SL 2.8 mg vs. placebo ) Efficacy analysis on N=231 patients ( mITT * population) • Key Secondary Measures: PROMIS Sle

  15. Slide 15: Dose-Effect in Military-Related PTSD

    © 2020 Tonix Pharmaceuticals Holding Corp. 15 TNX - 102 SL Phase 2 Dose - Effect in Military - Related PTSD 1 1 Completed Phase 2 P201/AtEase study: Retrospective analysis of TNX - 102 SL 5.6 mg on CAPS - 5 ≥33 (high - moderate) subgroup. Primary analysis of P201/ AtEase , based on TNX - 102 SL 2.8

  16. Slide 16: P301/HONOR Study – Evidence of Efficacy at Week 4

    © 2020 Tonix Pharmaceuticals Holding Corp. 16 P301/HONOR 1 Study – Evidence of Efficacy at Week 4 Discontinued Due to High Placebo Response at Week 12 Primary e ndpoint CAPS - 5 2 : • Mean change from baseline at W eek 12 (TNX - 102 SL 5.6 mg vs. placebo ) Unblinded interim analysis at 274 randomize

  17. Slide 17: Primary Outcome in Phase 3 Study: Retrospective Analysis

    © 2020 Tonix Pharmaceuticals Holding Corp. 17 Primary Outcome (CAPS - 5) in Phase 3 Study: Retrospective Analysis ≤9 Years Time Since Trauma (TST) Subgroup Phase 3 P301/HONOR Study 1 ** p=0.004, # p=0.069, * p=0.039, TNX - 102 SL 5.6 mg group v. placebo, using MMRM with MI ~50% mITT Population, ≤ 9

  18. Slide 18: Adverse Events in P201/AtEase and P301/HONOR Studies

    © 2020 Tonix Pharmaceuticals Holding Corp. 18 Adverse Events (AEs) in P201/AtEase and P301/HONOR Studies No serious and unexpected AEs in P201 or P301 related to TNX - 102 SL • Systemic AEs comparable between studies and also consistent with those described in approved oral cyclobenzaprine product l

  19. Slide 19: Phase 3 P302/RECOVERY Study for PTSD

    © 2020 Tonix Pharmaceuticals Holding Corp. 19 TNX - 102 SL for PTSD: Phase 3 P302/RECOVERY Study Expecting Interim Analysis Results in 1Q 2020 Potential pivotal efficacy study to support NDA approval Primary e ndpoint: • CAPS - 5 1 mean change from baseline at Week 12 (TNX - 102 SL 5.6 mg vs. placeb

  20. Slide 20: Opportunities to Expand to Other Indications

    © 2020 Tonix Pharmaceuticals Holding Corp. 20 Opportunities to Expand to Other Indications Growing recognition that there are many disorders where sleep disturbances may have a role in the pathophysiology (cardiovascular, metabolic, neurologic) • Sleep quality plays a homeostatic role in several dis

  21. Slide 21: Fibromyalgia Overview

    © 2020 Tonix Pharmaceuticals Holding Corp. 21 Volkswagen Check Engine [Photograph]. (2011, October 14). Wikipedia When the check engine light malfunctions, the light is on even though the car is not malfunctioning • Fibromyalgia is considered a neurobiological disorder characterized by 1 : chronic w

  22. Slide 22: Large Need for New Fibromyalgia Therapies

    © 2020 Tonix Pharmaceuticals Holding Corp. 22 Large Need for New Fibromyalgia Therapies that Provide Broad Symptom Improvement with Better Tolerability • Currently - approved medications may have side effects that limit long - term use 1 • High rates of discontinuation, switching and augmentation •

  23. Slide 23: Summary of Completed Phase 3 AFFIRM Study (F301)

    © 2020 Tonix Pharmaceuticals Holding Corp. 23 TNX - 102 SL 2.8 mg for Fibromyalgia Summary of Completed Phase 3 AFFIRM Study (F301) MMRM = mixed model repeated measures • 519 patients enrolled in 12 - week, double - blind trial • Randomized 1:1, placebo or TNX - 102 SL 2.8 mg (lowest possible dose),

  24. Slide 24: Phase 3 AFFIRM Study Results: Mean Pain Analysis

    © 2020 Tonix Pharmaceuticals Holding Corp. 24 *p<.05; **p<.01; ***p<.001 # As will be the case for the RELIEF F304 primary analysis, all discontinuations due to Adverse Event and Lack of Efficacy are imp uted using MI based on baseline values; all other discontinuations assumed to be Missing at Rand

  25. Slide 25: New Phase 3 Study for Fibromyalgia: Higher Dose, New Primary Endpoint

    © 2020 Tonix Pharmaceuticals Holding Corp. 25 TNX - 102 SL for Fibromyalgia New Phase 3 Study: Higher (2x) Dose, New Primary Endpoint • Clear guidance from FDA to advance fibromyalgia program using higher dose (5.6 mg) • Long - term safety of 5.6 mg dose used in PTSD expected to support fibromyalgia

  26. Slide 26: 5.6 mg for Fibromyalgia: New Phase 3 RELIEF Study Initiated

    © 2020 Tonix Pharmaceuticals Holding Corp. 26 TNX - 102 SL 5.6 mg for Fibromyalgia: New Phase 3 RELIEF Study Initiated Primary e ndpoint (Week 14) : • Daily diary pain severity score change (TNX - 102 SL 5.6 mg vs. placebo) from baseline in the weekly average as measured by the numerical rating scal

  27. Slide 27: CNS Candidates in Clinical Development

    © 2020 Tonix Pharmaceuticals Holding Corp. 27 CNS Candidates in Clinical Development Psychiatry, Pain and Addiction Phase 2 NDA 3 /BLA 4 Market Pipeline Product Indication Phase 3 TNX - 102 SL 1 Bedtime treatment for PTSD – Tonmya ®2 Daytime treatment for PTSD TNX - 601 CR 7 TNX - 1300 6 Cocaine Int

  28. Slide 28: Preclinical Pipeline

    © 2020 Tonix Pharmaceuticals Holding Corp. 28 Preclinical Pipeline 1 1 Experimental new medicines and biologics, not approved for any indication 2 (2S,4R,5R) - 5 - (((2 - aminobenzo[d]thiazol - 6 - yl)methyl)amino) - 2 - (bis(4 - fluorophenyl)methyl)tetrahydro - 2H - pyran - 4 - ol) is an inhibitor

  29. Slide 29: Pipeline Summary – by Select Therapeutic Areas

    © 2020 Tonix Pharmaceuticals Holding Corp. 29 Pipeline Summary – by Select Therapeutic Areas Psychiatry Pain Addiction Medicine Biodefense • TNX - 102 SL – (sublingual cyclobenzaprine) for PTSD Phase 3/RECOVERY FDA Breakthrough Therapy designation • TNX - 102 SL – (sublingual cyclobenzaprine) for ag

  30. Slide 30: Milestones – Recently Completed and Upcoming

    © 2020 Tonix Pharmaceuticals Holding Corp. 30 Milestones – Recently Completed and Upcoming □ May 2019 In - licensed TNX - 1300, in Phase 2 development for cocaine intoxication □ October 2019 Completed long - term exposure studies in PTSD to evaluate tolerability of TNX - 102 SL 5.6 mg □ October 2019

  31. Slide 31: Management Team

    © 2020 Tonix Pharmaceuticals Holding Corp. 31 Management Team Seth Lederman, MD President & CEO Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger, CPA Chief Financial Officer

  32. Slide 32: Financial Overview

    © 2020 Tonix Pharmaceuticals Holding Corp. 32 Financial Overview NASDAQ: TNXP Cash and cash equivalents, September 30, 2019 $10.0 million Net proceeds from equity offering in 4Q2019 $8.1 million Common stock outstanding as of January 13, 2020 8.5 million shares

  33. Slide 33: Thank you!

    © 2020 Tonix Pharmaceuticals Holding Corp. 33 Thank you ! NASDAQ: TNXP

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