Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (October 2019)

28 slides from Tonix Pharmaceuticals's investor presentation, Oct 16, 2019

  1. Slide 1: Investor Presentation, October 2019

    © 2019 Tonix Pharmaceuticals Holding Corp. 1 October 2019 Version P0200 10 - 16 - 19 (Doc 0543) Investor Presentation

  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, what we do

    © 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: Preclinical Pipeline

    © 2019 Tonix Pharmaceuticals Holding Corp. 5 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

  6. Slide 6: The focus of development is both unique and innovative

    © 2019 Tonix Pharmaceuticals Holding Corp. 6 The focus of TNX - 102 SL development is both unique and innovative • Testing the therapeutic benefit of sleep (‘sleep quality’) − Restorative sleep, in contrast to time spent sleeping (‘sleep quantity’) • Targeting clinical conditions for which improved

  7. Slide 7: Intellectual Property – U.S. Protection expected until 2035

    © 2019 Tonix Pharmaceuticals Holding Corp. 7 TNX - 102 SL Intellectual Property – U.S. Protection expected until 2035 • United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 9636408 in May 2017, U.S. Patent No. 9956188 in May 2018, U.S. Patent No. 10117936 in Nov 2018, and U.S. Pa

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

    © 2019 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

    © 2019 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) and GSK’s Paxil ® (paroxetine) circa 2000 • Neither has shown efficacy in military - related PTSD • Male PTSD patien

  10. Slide 10: Potential Therapeutic Advantages in PTSD: improving sleep quality

    © 2019 Tonix Pharmaceuticals Holding Corp. 10 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 • PTSD sufferers’ emotionally charged memories disturb sleep and disrupt the natural

  11. Slide 11: Phase 2 Dose-Effect in Military-Related PTSD

    © 2019 Tonix Pharmaceuticals Holding Corp. 11 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

  12. Slide 12: Primary Outcome (CAPS-5) in Phase 3 Study

    © 2019 Tonix Pharmaceuticals Holding Corp. 12 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 ~

  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: New Phase 3 P302/RECOVERY Study

    © 2019 Tonix Pharmaceuticals Holding Corp. 14 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

  15. Slide 15: Opportunities to Expand to Other Indications

    © 2019 Tonix Pharmaceuticals Holding Corp. 15 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) • Homeostatic role of sleep quality in several disorder

  16. Slide 16: Fibromyalgia: pain as a sensor system

    © 2019 Tonix Pharmaceuticals Holding Corp. 16 Volkswagen Check Engine [Photograph]. (2011, October 14). Wikipedia • Pain is a sensor system in the brain, similar to a check engine light on a car’s dashboard • When the check engine light malfunctions, the light is on even though the car is not malfun

  17. Slide 17: Potential Treatment for Agitation in Alzheimer's Disease

    © 2019 Tonix Pharmaceuticals Holding Corp. 17 TNX - 102 SL: Potential Treatment for Agitation in Alzheimer’s Disease (AAD) Agitation is one of the most distressing and debilitating of the behavioral complications of Alzheimer’s disease • Includes emotional lability, restlessness, irritability and ag

  18. Slide 18: Potential Treatment for Alcohol Use Disorder

    © 2019 Tonix Pharmaceuticals Holding Corp. 18 TNX - 102 SL: Potential Treatment for Alcohol Use Disorder (AUD) AUD is a chronic relapsing brain disease • Characterized by compulsive alcohol use, loss of control over alcohol intake, and a negative emotional state when not using Sleep disturbance is e

  19. Slide 19: TNX-1300 for the Treatment of Cocaine Intoxication

    © 2019 Tonix Pharmaceuticals Holding Corp. 19 TNX - 1300* for the Treatment of Cocaine Intoxication Recombinant protein that degrades cocaine in the bloodstream 1 • Double - mutant cocaine esterase ( CocE ) • CocE was identified in bacteria ( Rhodococcus ) that use cocaine as its sole source of carb

  20. Slide 20: Pharmacotherapies for Cocaine Intoxication Have Not Been Effective

    © 2019 Tonix Pharmaceuticals Holding Corp. 20 Pharmacotherapies for Cocaine Intoxication Have Not Been Effective 1. Brim et al. Mol Pharmacol . 2011. 2. Melichar et al. Eur J Phamacol . 2003. 3. Narasimhan et al. Future Medicinal Chemistry. 2012. Opiates Simple; mediated by opioid receptors 2 Agonis

  21. Slide 21: TNX-1300 Is a Fast-acting Cocaine Antidote

    © 2019 Tonix Pharmaceuticals Holding Corp. 21 TNX - 1300 (Cocaine Esterase or CocE ) Is a Fast - acting Cocaine Antidote CocE Rhodococcus bacteria living in the roots of the coca plant use CocE to metabolize cocaine 1 CocE cleaves chemical bonds in cocaine and disintegrates it 800 times faster than

  22. Slide 22: Cocaine Intoxication Is a Growing Problem in the U.S.

    Cocaine Intoxication Is a Growing Problem in the U.S. National Drug Overdose Deaths Involving Cocaine 0 5000 10000 15000 Cocaine is involved in more emergency department (ED) visits than any other illicit substance 1 Drug overdose deaths involving cocaine have increased dramatically in recent years

  23. Slide 23: TNX-601 (Tianeptine Oxalate): Potential Daytime Treatment for PTSD

    © 2019 Tonix Pharmaceuticals Holding Corp. 23 TNX - 601 (Tianeptine Oxalate): A Potential Daytime Treatment 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 analysi

  24. Slide 24: Management Team

    © 2019 Tonix Pharmaceuticals Holding Corp. 24 Management Team Seth Lederman, MD President & CEO Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger, CPA Chief Financial Officer

  25. Slide 25: Milestones – Recently Completed and Upcoming

    © 2019 Tonix Pharmaceuticals Holding Corp. 25 Milestones – Recently Completed and Upcoming □ November 201 8 Received FDA minutes confirming agreement on the design of P302/RECOVERY study □ March 2019 P302/RECOVERY study initiated □ April 2019 Received FDA formal minutes with clear guidance and suppo

  26. Slide 26: Pipeline Summary – by Select Therapeutic Areas

    © 2019 Tonix Pharmaceuticals Holding Corp. 26 Pipeline Summary – by Select Therapeutic Areas • Psychiatry/PTSD: • TNX - 102 SL – (sublingual cyclobenzaprine) for PTSD • Phase 3 • TNX - 601 – (tianeptine) for PTSD • Phase 1 formulation development • TNX - 1600 – (triple reuptake inhibitor) for PTSD •

  27. Slide 27: Pipeline Summary – by Phase of Development

    © 2019 Tonix Pharmaceuticals Holding Corp. 27 Pipeline Summary – by Phase of Development Two Phase 3 Programs in indications affecting millions of Americans • TNX - 102 SL for PTSD: affects 12 million adults in U.S. • TNX - 102 SL for Fibromyalgia: affects between 5 - 10 million adults in U.S. Two P

  28. Slide 28: Thank you!

    © 2019 Tonix Pharmaceuticals Holding Corp. 28 Thank you ! NASDAQ: TNXP

Tonix Pharmaceuticals Holding — Investor Presentation (October 2019) on 6ix