Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (April 2018)

31 slides from Tonix Pharmaceuticals's investor presentation, Apr 3, 2018

  1. Slide 1: Investor Presentation

    © 2018 Tonix Pharmaceuticals Holding Corp. April 2018 Version P0108 4 - 3 - 18 (Doc 0336) 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 Lead Program Tonmya ®1 - FDA Breakthrough Therapy in PTSD 2 • Phase 3 HONOR study enrolling - bedtime treatment for PTSD TNX - 102 SL 3 - Bedtime treatment for agitation in Alzheimer’s disease • Phase 2 IND submitted in March 2018 TNX - 601 4 - Pre - IND

  4. Slide 4: Management Team

    © 2018 Tonix Pharmaceuticals Holding Corp. 4 Management Team Seth Lederman, MD President & CEO Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger, CPA Chief Financial Officer

  5. Slide 5: Board of Directors

    © 2018 Tonix Pharmaceuticals Holding Corp. 5 Board of Directors Seth Lederman, MD Chairman Ernest Mario, PhD ALZA, Glaxo, Reliant Pharma John Rhodes Chair, NYS Public Service Commission, CEO, NYS Dept. of Public Service, Booz Allen Samuel Saks, MD Jazz Pharma, ALZA, Johnson & Johnson Charles Mather

  6. Slide 6: Candidates in Development

    © 2018 Tonix Pharmaceuticals Holding Corp. 6 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 TNX - 801 Horse

  7. Slide 7: Tonmya for PTSD

    © 2018 Tonix Pharmaceuticals Holding Corp. 7 Tonmya for PTSD Phase 3 HONOR study in military - related PTSD enrolling • Encouraging evidence of safety and efficacy was demonstrated in Phase 2 • Higher entry CAPS - 5 criterion used in Phase 3 1 Breakthrough Therapy designation from the FDA • Expedite

  8. Slide 8: Phase 3 HONOR Study Enrolling

    © 2018 Tonix Pharmaceuticals Holding Corp. 8 Phase 3 HONOR Study Enrolling • General s tudy c haracteristics: • Randomized, double - blind, placebo - controlled . • ~ 550 participants in approximately 40 U.S. sites . • Unblinded interim analysis will be reviewed by IDMC* to determine: ( i ) Early st

  9. Slide 9: Go to: thehonorstudy.com

    © 2018 Tonix Pharmaceuticals Holding Corp. 9 Go to: https://thehonorstudy.com/

  10. Slide 10: Breakthrough Therapy Designation Granted to Tonmya by FDA

    © 2018 Tonix Pharmaceuticals Holding Corp. 10 Breakthrough Therapy Designation Granted to Tonmya by FDA December 19, 2016 • PTSD is a serious condition • Tonmya has potential advantages over existing therapies in military - related PTSD Benefits of Breakthrough Therapy designation • Eligibility for

  11. Slide 11: Tonmya: Features in PTSD Therapy

    © 2018 Tonix Pharmaceuticals Holding Corp. 11 Tonmya: Features in PTSD Therapy Designed for bedtime use • Every night, sublingual therapy Targets sleep quality 1 • The active ingredient cyclobenzaprine, interacts with receptors that regulate sleep quality: strongly binds and potently blocks 5 - HT 2

  12. Slide 12: PTSD Characteristics

    © 2018 Tonix Pharmaceuticals Holding Corp. 12 PTSD Characteristics Symptoms of PTSD fall into four clusters: 1. Intrusion 2. Avoidance 3. Mood/cognitions 4. Hyperarousal PTSD is a risk factor for: • Depression • Alcohol or substance abuse • Absenteeism/unemployment • Homelessness • Violent acts • Su

  13. Slide 13: PTSD: Not Well-Served by Approved Treatments

    © 2018 Tonix Pharmaceuticals Holding Corp. 13 PTSD: Not Well - Served by Approved Treatments Majority of patients unresponsive or intolerant to current treatments • FDA - approved SSRIs have not shown efficacy in military - related PTSD • Side effects relating to sexual dysfunction (particularly in

  14. Slide 14: High Prevalence of PTSD Among Combat Veterans

    © 2018 Tonix Pharmaceuticals Holding Corp. 14 High Prevalence of PTSD Among Combat Veterans 1 Kessler et al., Arch Gen Psych 2005; Prevalence rate of 3.5% applied to U.S. Census estimate of 247M U.S. adult ( > 18) population in 2015 ( www.census.gov/quickfacts/table/PST045215/00 ) ; 2 Norris, PTSD R

  15. Slide 15: Phase 2 AtEase Study in Military-Related PTSD

    © 2018 Tonix Pharmaceuticals Holding Corp. 15 Phase 2 AtEase Study in Military - Related PTSD • Randomized, double - blind, placebo - controlled trial • Efficacy analysis from 231 patients in 24 U.S. sites • Entry CAPS - 5 ≥ 29 • Primary Analysis: • Difference in CAPS - 5 score change from baseline

  16. Slide 16: AtEase Study: Top Traumas Associated with PTSD

    © 2018 Tonix Pharmaceuticals Holding Corp. 16 AtEase Study: Top 5 Traumas Associated with PTSD *Some patients experienced more than one trauma IED = Improvised explosive device

  17. Slide 17: AtEase Study – Primary Endpoint

    © 2018 Tonix Pharmaceuticals Holding Corp. 17 AtEase Study – Primary Endpoint CAPS - 5 Change From Baseline at Week 12 Statistical Analysis Based on Missing Data Handling

  18. Slide 18: AtEase Study: Safety and Tolerability Profile

    © 2018 Tonix Pharmaceuticals Holding Corp. 18 AtEase Study: Safety and Tolerability Profile No serious adverse events reported with Tonmya deemed related to treatment Systemic Adverse Events* Placebo (N=94) Tonmya 2.8 mg (N=93) Tonmya 5.6 mg (N=50) Somnolence 6.4% 11.8% 16.0% Dry Mouth 10.6% 4.3% 16

  19. Slide 19: AtEase Study: Total CAPS-5 for ITT and Subgroup

    © 2018 Tonix Pharmaceuticals Holding Corp. 19 AtEase Study: Total CAPS - 5 for Intention - to - Treat Population and Retrospective Analysis for Subgroup with Entry CAPS - 5 ≥33 A baseline CAPS - 5 score ≥33 was set as entry criterion in Phase 3 HONOR study Intention - to - Treat Population Subgroup

  20. Slide 20: AtEase Study: Effect Sizes for Total CAPS-5 and Symptom Clusters

    © 2018 Tonix Pharmaceuticals Holding Corp. 20 0.53 0.46 0.12 0.39 0.52 0 0.1 0.2 0.3 0.4 0.5 0.6 Effect Size AtEase Study: Effect Sizes for Total CAPS - 5 and Symptom Clusters for Intention - to - Treat Population and Subgroup with Entry CAPS - 5 ≥33 Effect Sizes in Tonmya 5.6 mg in AtEase Subgroup

  21. Slide 21: AtEase Study Retrospective Analysis: Remission

    © 2018 Tonix Pharmaceuticals Holding Corp. 21 AtEase Study Retrospective Analysis: Remission in Subgroup with Entry CAPS - 5 ≥33 Remission = Loss of Diagnosis and CAPS - 5 < 11 Asterisk and hashmark represent pairwise comparisons between Tonmya and Placebo; # p=0.08, Odds Ratio 3.01 (0.89, 10.18) *p

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

    © 2018 Tonix Pharmaceuticals Holding Corp. 22 TNX - 102 SL – Multiple Potential Indications Management of Fibromyalgia (FM) – chronic pain condition • TNX - 102 SL clinical development in FM was halted after near miss in Phase 3 at low dose (2.8 mg) – PTSD therapeutic dose is 5.6 mg • Low dose TNX -

  23. Slide 23: Consequences of Agitation in Alzheimer's Disease

    © 2018 Tonix Pharmaceuticals Holding Corp. 23 Consequences of Agitation in Alzheimer’s Disease Outcomes • Agitation challenges caregivers and is one of the most common reasons for patients having to transition from lower - to higher levels of care (nursing homes and other long - term care settings)

  24. Slide 24: Agitation in Alzheimer's Disease – Potential New Indication

    © 2018 Tonix Pharmaceuticals Holding Corp. 24 Agitation in Alzheimer’s Disease – Potential New Indication for TNX - 102 SL Successful pre - IND meeting in November 2017 • Phase 2 IND submitted March 2018 Significant unmet need • No FDA approved drugs for the treatment of agitation in Alzheimer’s Mec

  25. Slide 25: Candidates in Development

    © 2018 Tonix Pharmaceuticals Holding Corp. 25 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 TNX - 801 Hors

  26. Slide 26: TNX-601: A Potential Clinical Candidate for PTSD

    © 2018 Tonix Pharmaceuticals Holding Corp. 26 TNX - 601 1 : 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 analysis, etc.) x Mechan

  27. Slide 27: TNX-801: A Smallpox-Preventing Vaccine Candidate

    © 2018 Tonix Pharmaceuticals Holding Corp. 27 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

  28. Slide 28: Current Needs to Vaccinate Against Smallpox

    © 2018 Tonix Pharmaceuticals Holding Corp. 28 Ongoing vaccination of U.S. troops • Troops in the Global Response Force Threat of smallpox re - introduction • Strategic National Stockpile & public health policy Re - emergence of monkey pox 1 • Believed to resurgent because of vaccinia - naïve populat

  29. Slide 29: Upcoming Milestones

    © 2018 Tonix Pharmaceuticals Holding Corp. 29 Upcoming Milestones T onmya – Posttraumatic Stress Disorder □ 2Q 2018 Randomization of 50% of HONOR study participants □ 3Q 201 8 Anticipated interim analysis of HONOR study in ~ 275 randomized participants □ 4Q 201 8 Anticipated topline results of HONOR

  30. Slide 30: Summary

    © 2018 Tonix Pharmaceuticals Holding Corp. 30 Summary Near term milestones in Phase 3 program PTSD focused on military - related PTSD • Major unmet need; 8.6 Million Americans affected • Potential for NDA approval based on one study New indication for agitation in Alzheimer’s Disease • Phase 2 IND s

  31. Slide 31: Thank you!

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

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