Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (November 2018)

30 slides from Tonix Pharmaceuticals's investor presentation, Nov 30, 2018

  1. Slide 1: Investor Presentation November 2018

    © 2018 Tonix Pharmaceuticals Holding Corp. November 2018 Version P0147 11 - 30 - 18 (Doc 0418) Investor Presentation

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

    © 2018 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 Development Highlights

    © 2018 Tonix Pharmaceuticals Holding Corp. 3 Tonmya ®1 – lead program; FDA Breakthrough Therapy for Posttraumatic Stress Disorder (PTSD) – Bedtime treatment in Phase 3 Development • Results from 2 efficacy studies improve the new Phase 3 study design • New Phase 3 P302/RECOVERY study design features

  4. Slide 4: Prevalence of PTSD Among Civilians and Veterans

    © 2018 Tonix Pharmaceuticals Holding Corp. 4 Prevalence of PTSD Among Civilians and Veterans 1 Goldstein et al., 2016 ; 2 Norris, PTSD Res Quar . 2013; 3 Analysis of VA Health Care Utilization among Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn Veterans, from 1st Qtr FY

  5. Slide 5: TNX-102 SL Intellectual Property – U.S. Protection until 2034

    © 2018 Tonix Pharmaceuticals Holding Corp. 5 TNX - 102 SL Intellectual Property – U.S. Protection until 2034 Composition of matter (eutectic) : Protection expected to 2034 • United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 9,636,408 in May 201 7U.S. Patent No. 9,956,188 in Ma

  6. Slide 6: Tonmya - Breakthrough Therapy for Treatment of PTSD Targets Sleep Disturbance

    © 2018 Tonix Pharmaceuticals Holding Corp. 6 Tonmya® 1 - Breakthrough Therapy for Treatment of PTSD Targets Sleep Disturbance Tonmya - first investigational new drug to show treatment effect in military - related PTSD in two large, 12 - week, multi - center studies Retrospective analyses showed Tonm

  7. Slide 7: Need for Effective and Safe Therapies for Treatment of Military PTSD

    © 2018 Tonix Pharmaceuticals Holding Corp. 7 Need for Effective and Safe Therapies for Treatment of Military PTSD PTSD is signature wound of last 25 years of war • Affects servicemember health and performance, force readiness, retention • Believed to be the underlying cause of suicide in many cases

  8. Slide 8: Potential Therapeutic Advantages of Tonmya

    © 2018 Tonix Pharmaceuticals Holding Corp. 8 Potential Therapeutic Advantages of Tonmya Tonmya is believed to treat PTSD by improving sleep quality • The brain naturally processes memories during sleep • PTSD sufferers’ emotionally charged memories disturb sleep and disrupt the natural processing of

  9. Slide 9: Tonmya for the Treatment of PTSD

    © 2018 Tonix Pharmaceuticals Holding Corp. 9 Tonmya for the Treatment of PTSD One Phase 2 study completed and one Phase 3 study stopped early due to inadequate separation from placebo • Both studies were accepted by the FDA as potential pivotal efficacy studies in military - related PTSD if successf

  10. Slide 10: Tonmya Dose-Effect in Military-Related PTSD

    © 2018 Tonix Pharmaceuticals Holding Corp. 10 Tonmya Dose - Effect in Military - Related PTSD 1 1 Phase 2 P201/AtEase study: Retrospective analysis of Tonmya 5.6 mg on CAPS - 5 ≥33 (high - moderate) subgroup. Primary analysis of P 201/AtEase was on Tonmya 2.8 mg in participants with entry CAPS - 5 ≥

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

    © 2018 Tonix Pharmaceuticals Holding Corp. 11 Retrospective Comparison of Time Since Trauma in P201/AtEase versus P301/HONOR (Tonmya 5.6 mg Groups) P301 study was initiated approximately two years later than Phase 2 P201 • The median time since trauma in Phase 3 was 9.5 years compared to the median

  12. Slide 12: CAPS-5 Mean Change from Baseline Difference from Placebo by Time Since Trauma

    © 2018 Tonix Pharmaceuticals Holding Corp. 12 CAPS - 5 Mean Change from Baseline Difference from Placebo of Tonmya 5.6 mg in TST Subgroupings MCFB=mean change from baseline; ‘N’=number of participants in group; PBO=placebo; TST=time since trauma • The mITT sample was divided into groups based on TST

  13. Slide 13: Primary Outcome (CAPS-5) in Phase 3 mITT and ≤9 Years Subgroups

    © 2018 Tonix Pharmaceuticals Holding Corp. Primary Outcome (CAPS - 5) in Phase 3 ( mITT ) and ≤9 Years Time Since Trauma (TST) Subgroups Modified intent to treat ( mITT ) population Phase 3 P301/HONOR Study ** p=0.004, * p=0.039, # p=0.069, TNX - 102 SL 5.6 mg group v. placebo, using MMRM with MI ~5

  14. Slide 14: Sustained Remission in Phase 2 and Phase 3 Studies

    © 2018 Tonix Pharmaceuticals Holding Corp. 14 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

  15. Slide 15: Adverse Events in P201/AtEase and P301/HONOR Studies

    © 2018 Tonix Pharmaceuticals Holding Corp. 15 Adverse Events (AEs) in P201/AtEase and P301/HONOR Studies No serious and unexpected AEs in P201 or P301 • Systemic AEs comparable between studies and also consistent with those described in approved cyclobenzaprine product labeling • Similar severity an

  16. Slide 16: Response to Tonmya for Female Participants in P301/HONOR Study

    © 2018 Tonix Pharmaceuticals Holding Corp. 16 Response to Tonmya for Female Participants in P301/HONOR Study • Females made up only 11% of the P301/HONOR study mITT population • Difference in mean change from baseline in CAPS - 5 in females between placebo (N=17) and Tonmya 5.6 mg (N=10) was: • At 4

  17. Slide 17: Response to Tonmya for Non-Combat Traumas in P301/HONOR Study

    © 2018 Tonix Pharmaceuticals Holding Corp. 17 • Non - combat traumas studied are similar to traumas experienced in civilian populations with PTSD • To determine the therapeutic effects of Tonmya 5.6 mg in a mixed civilian and military population, difference in MCFB in CAPS - 5 was assessed in non -

  18. Slide 18: Summary of Clinical Experience with Tonmya/TNX-102 SL in PTSD

    © 2018 Tonix Pharmaceuticals Holding Corp. 18 Summary of Clinical Experience with Tonmya/ TNX - 102 SL in PTSD Median time since trauma (TST) in TNX - 102 SL 5.6 mg group in the P301/HONOR study (9.5 years) was longer than P201/AtEase study (6 years) • Both studied military - related PTSD • Time has

  19. Slide 19: New Phase 3 Study (P302/RECOVERY) Features

    © 2018 Tonix Pharmaceuticals Holding Corp. 19 Tonmya/TNX - 102 SL – New Phase 3 Study (P302/RECOVERY) Features In two prior clinical trials, Tonmya 5.6 mg consistently reduced military - related PTSD severity for participants with ≤ 9 years since trauma These data provide the rationale to study Tonm

  20. Slide 20: New Phase 3 P302/RECOVERY Study – To Start 1Q 2019

    © 2018 Tonix Pharmaceuticals Holding Corp. 20 New Phase 3 P302/RECOVERY Study – To Start 1Q 2019 Primary e ndpoint CAPS - 5 1 : • Mean change from baseline at W eek 4 (Tonmya 5.6 mg vs. placebo ) Key Secondary e ndpoint s include: • CAPS - 5 m ean change from baseline at W eek 12 (Tonmya 5.6 mg vs.

  21. Slide 21: Late-Stage PTSD Drug Candidates

    © 2018 Tonix Pharmaceuticals Holding Corp. 21 Late - Stage PTSD Drug Candidates Tonmya • Breakthrough Therapy in Phase 3; only development program focused on military - related and civilian PTSD, only drug to show activity in treatment of military - related PTSD in large multi - center trials MDMA -

  22. Slide 22: TNX-102 SL – Bedtime Treatment for Multiple Potential Indications

    © 2018 Tonix Pharmaceuticals Holding Corp. 22 TNX - 102 SL – Bedtime Treatment for Multiple Potential Indications Ma nagement of Fibromyalgia (FM) – chronic pain condition • TNX - 102 SL studied at low dose (2.8 mg) – half the dose being developed for PTSD – did not separate from placebo on primary

  23. Slide 23: TNX-102 SL for Agitation in Alzheimer's – Regulatory Status and Registration Strategy

    © 2018 Tonix Pharmaceuticals Holding Corp. 23 TNX - 102 SL for Agitation in Alzheimer’s – Regulatory Status and Registration Strategy FDA confirmed no additional study is needed prior to IND submission • Pre - IND meeting established open dialogue with the FDA on pivotal clinical study design and ef

  24. Slide 24: Candidates in Development

    © 2018 Tonix Pharmaceuticals Holding Corp. 24 Candidates in Development Preclinical Phase 2 NDA 1 /BLA 2 Market Pipeline Product Indication/ Description Phase 3 Tonmya Bedtime Treatment for PTSD Daytime Treatment for PTSD TNX - 601 Novel polymorph and salt discovered and characterized; Preliminary h

  25. Slide 25: TNX-601 (Tianeptine Oxalate): A Potential Clinical Candidate for PTSD

    © 2018 Tonix Pharmaceuticals Holding Corp. 25 TNX - 601 ( Tianeptine Oxalate): A Potential Clinical Candidate for PTSD Pre - IND Candidate Targeted as a 1 st line monotherapy for PTSD: oral formulation for daytime dosing x Leverages expertise in PTSD (clinical and regulatory experience, market analy

  26. Slide 26: TNX-801 (Synthesized Live Horsepox Virus): A Smallpox-Preventing Vaccine Candidate

    © 2018 Tonix Pharmaceuticals Holding Corp. 26 TNX - 801 (Synthesized Live Horsepox Virus): A Smallpox - Preventing Vaccine Candidate Pre - IND Stage Potential improvement over current biodefense tools against smallpox ✓ Leverages Tonix’s government affairs effort ✓ Collaboration with Professor David

  27. Slide 27: Management Team

    © 2018 Tonix Pharmaceuticals Holding Corp. 27 Management Team Seth Lederman, MD President & CEO Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger, CPA Chief Financial Officer

  28. Slide 28: Milestones – Recently Completed and Upcoming

    © 2018 Tonix Pharmaceuticals Holding Corp. 28 Milestones – Recently Completed and Upcoming □ July 201 8 Completed P301/HONOR study interim analysis - result did not support study continuation but strengthened new Phase 3 study □ August 201 8 Presentation of P301/HONOR study results at Military Healt

  29. Slide 29: Summary

    © 2018 Tonix Pharmaceuticals Holding Corp. 29 Summary Phase 3 development of Breakthrough Therapy treatment for PTSD, including military - related PTSD • Major unmet need; ~11 million Americans affected • Benefited from FDA 505(b)(2) NDA approval requirement New indication in development for agitati

  30. Slide 30: Thank you!

    © 2018 Tonix Pharmaceuticals Holding Corp. Thank you ! NASDAQ: TNXP

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