Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (September 2019)

21 slides from Tonix Pharmaceuticals's investor presentation, Sep 16, 2019

  1. Slide 1: Presentation to NAVREF

    © 2019 Tonix Pharmaceuticals Holding Corp. 1 September 2019 Version P0196 9 - 16 - 19 (Doc 0535) Presentation to NAVREF

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

    © 2019 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: Who we are

    © 2019 Tonix Pharmaceuticals Holding Corp. 3 Tonix Pharmaceuticals Who we are: • A clinical stage biopharmaceutical company dedicated to developing innovative treatments for patients and making meaningful contributions to society • Focusing on small molecules and biologics to treat psychiatric, pain

  4. Slide 4: CNS Candidates in Clinical Development

    © 2019 Tonix Pharmaceuticals Holding Corp. 4 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 7 TNX - 1300 6 Cocaine intoxic

  5. Slide 5: Pipeline Summary – by Therapeutic Area

    © 2019 Tonix Pharmaceuticals Holding Corp. 5 Pipeline Summary – by Therapeutic Area • Psychiatry/PTSD: • TNX - 102 SL – (sublingual cyclobenzaprine) for PTSD • Phase 3 • TNX - 601 1 – (tianeptine) for PTSD • Phase 1 formulation development • TNX - 1600 2 – (triple reuptake inhibitor) for PTSD 3 • Pr

  6. Slide 6: Unmet Need for Effective and Safe Therapies for Treatment of PTSD

    © 2019 Tonix Pharmaceuticals Holding Corp. 6 Unmet Need for Effective and Safe Therapies for Treatment of PTSD No FDA - approved products for PTSD since Pfizer’s Zoloft ® (sertraline) and GSK’s Paxil ® (paroxetine) circa 2000 • Neither has shown efficacy in military - related PTSD • Male PTSD patien

  7. Slide 7: a Potential Bedtime Treatment for PTSD

    © 2019 Tonix Pharmaceuticals Holding Corp. 7 TNX - 102 SL: a Potential Bedtime Treatment for PTSD First investigational new drug to show treatment effect in military - related PTSD in two potential pivotal efficacy studies • Phase 2 study (P201/ AtEase ) showed TNX - 102 SL 5.6 mg had a strong signa

  8. Slide 8: Potential Therapeutic Advantages

    © 2019 Tonix Pharmaceuticals Holding Corp. 8 Potential Therapeutic Advantages of TNX - 102 SL TNX - 102 SL is believed to treat PTSD by improving sleep quality • The brain naturally processes memories during sleep • In PTSD emotionally charged memories disturb sleep and disrupt memory processing • T

  9. Slide 9: Dose-Effect in Military-Related PTSD

    © 2019 Tonix Pharmaceuticals Holding Corp. 9 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 m

  10. Slide 10: Primary Outcome (CAPS-5) in Phase 3 Study: mITT and ≤9 Years Time Since Trauma

    © 2019 Tonix Pharmaceuticals Holding Corp. 10 Primary Outcome (CAPS - 5) in Phase 3 Study: mITT and ≤9 Years Time Since Trauma Subgroup Modified intent to treat ( mITT ) population Phase 3 P301/HONOR Study 1 ** p=0.004, * p=0.039, # p=0.069, TNX - 102 SL 5.6 mg group v. placebo, using MMRM with MI ~

  11. Slide 11: Retrospective Comparison of Time Since Trauma in P201/AtEase versus P301/HONOR

    © 2019 Tonix Pharmaceuticals Holding Corp. 11 Retrospective Comparison of Time Since Trauma in P201/AtEase versus P301/HONOR (TNX - 102 SL 5.6 mg Groups) P301 study was initiated approximately two years later than Phase 2 P201 • The median time since trauma in P301 was 9.5 years compared to the medi

  12. Slide 12: Sustained Remission in Phase 2 and Phase 3 Studies

    © 2019 Tonix Pharmaceuticals Holding Corp. 12 Sustained Remission in Phase 2 and Phase 3 Studies: Retrospective Analyses of P201 Entry CAPS - 5 ≥33 and P301 ≤9 Years Since Trauma Subgroups Remission is a clinical state that is essentially asymptomatic In order to confirm remission: • Determined rate

  13. Slide 13: Adverse Events in P201/AtEase and P301/HONOR Studies

    © 2019 Tonix Pharmaceuticals Holding Corp. 13 Adverse Events (AEs) in P201/AtEase and P301/HONOR Studies No serious or 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 la

  14. Slide 14: Time Since Trauma – Remitting and Persistent Phases of PTSD

    © 2019 Tonix Pharmaceuticals Holding Corp. 14 Time Since Trauma – Remitting and Persistent Phases of PTSD Kessler et al 1 studied remission in PTSD with and without therapy • Identified remitting and persistent phase of PTSD – with transition at approximately 6 years post trauma • Supported by other

  15. Slide 15: New Phase 3 P302/RECOVERY Study – Initiated 1Q 2019

    © 2019 Tonix Pharmaceuticals Holding Corp. 15 TNX - 102 SL for PTSD: New Phase 3 P302/RECOVERY Study – Initiated 1Q 2019 Primary e ndpoint: • CAPS - 5 1 mean change from baseline at Week 4 (TNX - 102 SL 5.6 mg vs. placebo) Key Secondary e ndpoint s include: • CAPS - 5 m ean change from baseline at W

  16. Slide 16: Clear Suicide-PTSD Link Among Veterans Using the VHA

    © 2019 Tonix Pharmaceuticals Holding Corp. 16 Clear Suicide - PTSD Link Among Veterans Using the Veterans Health Administration (VHA) 1 40 Between 2005 and 2015, rates of suicide remained stable across cohorts of Veteran VHA patients diagnosed with a mental health condition or substance use disorder

  17. Slide 17: Potential to Decrease Suicidal Behaviors in PTSD, Sleep Disorders and Depression

    © 2019 Tonix Pharmaceuticals Holding Corp. 17 Potential for TNX - 102 SL to Decrease Suicidal Behaviors in PTSD, Sleep Disorders and Depression Suicidal Behaviors PTSD Depression Schizophrenia Bipolar Clozaril  (clozapine) Effective for suicidal behaviors in schizophrenia Lithium* Effective for sui

  18. Slide 18: Crisis in the Pharmacotherapy of PTSD Endures

    © 2019 Tonix Pharmaceuticals Holding Corp. 18 Crisis in the Pharmacotherapy of PTSD Endures “The urgent need to find effective pharmacologic treatments for PTSD should be considered a national mental health priority.” - From the Consensus Statement of the PTSD Psychopharmacology Working Group 1 • De

  19. Slide 19: President's Roadmap to Empower Veterans and End a National Tragedy of Suicide – PREVENTS

    © 2019 Tonix Pharmaceuticals Holding Corp. 19 President’s Roadmap to Empower Veterans and End a National Tragedy of Suicide – “PREVENTS” 1 • Executive Order on a National Roadmap to Empower Veterans and End Suicide – March 19 2019 • Task force empaneled; VA Secretary Wilkie is Co - Chair • Dr. Barba

  20. Slide 20: PTSD – New Learnings and Recommendations

    © 2019 Tonix Pharmaceuticals Holding Corp. 20 PTSD – New Learnings and Recommendations • PTSD within 9 years of trauma has a higher rate of drug responsiveness to TNX - 102 SL • Decrease in spontaneous remission after ~6 years in the National Comorbidity study supports loss of plasticity over time 1

  21. Slide 21: Thank you!

    © 2019 Tonix Pharmaceuticals Holding Corp. 21 Thank you ! NASDAQ: TNXP

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