Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (December 2019)

35 slides from Tonix Pharmaceuticals's investor presentation, Dec 18, 2019

  1. Slide 1: Investor Presentation December 2019

    © 2019 Tonix Pharmaceuticals Holding Corp. 1 December 2019 Version P0212 12 - 17 - 19 (Doc 0576) 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

    © 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 CR 7 TNX - 1300 6 Cocaine into

  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) in 1999 and GSK’s Paxil ® (paroxetine) in 2001 • Neither has shown efficacy in military - related PTSD • Side effect

  10. Slide 10: Potential Therapeutic Advantages in PTSD

    © 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: 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 PTSD Symptoms (CAPS - 5 Score) Modified intent to treat ( mITT ) population Phase 3 P301/HONOR Study 1 ** p=0.004, # p=0.069 , * p=0.039, TNX - 102 SL 5.6 mg group

  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: Phase 3 P302/RECOVERY Study Interim Analysis in 1Q 2020

    © 2019 Tonix Pharmaceuticals Holding Corp. 14 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

  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 as a Neurobiological Disorder

    © 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: Large Need for New Fibromyalgia Therapies

    © 2019 Tonix Pharmaceuticals Holding Corp. 17 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 • Many patients skip doses or discontinue altogether within mo

  18. Slide 18: Fibromyalgia: Phase 3 AFFIRM Study (F301) Results

    © 2019 Tonix Pharmaceuticals Holding Corp. 18 TNX - 102 SL 2.8 mg for Fibromyalgia: Summary of Completed Phase 3 AFFIRM Study (F301) and Results General s tudy c haracteristics: • Randomized, 12 - week, double - blind, placebo - controlle d Phase 3 study of TNX - 102 SL 2.8 mg (half the dose being d

  19. Slide 19: Phase 3 AFFIRM Mean Pain Analysis

    © 2019 Tonix Pharmaceuticals Holding Corp. 19 *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

  20. Slide 20: Fibromyalgia: F301 Study Results and Program Updates

    © 2019 Tonix Pharmaceuticals Holding Corp. 20 TNX - 102 SL 2.8 mg for Fibromyalgia: F301 Study Results and Program Updates Safety results: • Good tolerability and low rates of systemic AEs. • The most common AEs were generally mild and transient events related to the sublingual administration of the

  21. Slide 21: 5.6 mg for Fibromyalgia: New Phase 3 RELIEF Study

    © 2019 Tonix Pharmaceuticals Holding Corp. 21 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 by numerical rating scale (NRS) analyzed

  22. Slide 22: Potential Treatment for Agitation in Alzheimer's Disease

    © 2019 Tonix Pharmaceuticals Holding Corp. 22 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

  23. Slide 23: Potential Treatment for Alcohol Use Disorder

    © 2019 Tonix Pharmaceuticals Holding Corp. 23 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

  24. Slide 24: TNX-1300 for the Treatment of Cocaine Intoxication

    © 2019 Tonix Pharmaceuticals Holding Corp. 24 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

  25. Slide 25: Pharmacotherapies for Cocaine Intoxication Have Not Been Effective

    © 2019 Tonix Pharmaceuticals Holding Corp. 25 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

  26. Slide 26: TNX-1300 Is a Fast-acting Cocaine Antidote

    © 2019 Tonix Pharmaceuticals Holding Corp. 26 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

  27. Slide 27: 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

  28. Slide 28: TNX-601 CR (Tianeptine Oxalate Controlled Release) Tablets

    © 2019 Tonix Pharmaceuticals Holding Corp. 28 TNX - 601 CR* (Tianeptine Oxalate Controlled Release) Tablets Proprietary new controlled release formulation for once - daily dosing • Suitability for once - daily dosing established in Phase 1 pharmacokinetic study, completed outside of the U.S. • Well

  29. Slide 29: TNX-601 CR: Potential Daytime Treatment for Depression and PTSD

    © 2019 Tonix Pharmaceuticals Holding Corp. 29 TNX - 601 CR : A Potential Daytime Treatment for Depression and PTSD Depression: majority suffering from depression do not have an adequate response to initial antidepressant therapy • Tianeptine sodium immediate release (IR) tablets for three times a da

  30. Slide 30: Financial Overview

    © 2019 Tonix Pharmaceuticals Holding Corp. 30 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 December 17, 2019 8.5 million shares

  31. Slide 31: Management Team

    © 2019 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: Milestones – Recently Completed and Upcoming

    © 2019 Tonix Pharmaceuticals Holding Corp. 32 Milestones – Recently Completed and Upcoming □ March 2019 P302/RECOVERY study initiated □ April 2019 Received FDA formal minutes with clear guidance and support for new Phase 3 FM study using TNX - 102 SL 5.6 mg □ May 2019 In - licensed TNX - 1300, produ

  33. Slide 33: Pipeline Summary – by Select Therapeutic Areas

    © 2019 Tonix Pharmaceuticals Holding Corp. 33 Pipeline Summary – by Select Therapeutic Areas • Psychiatry/PTSD: • TNX - 102 SL – (sublingual cyclobenzaprine) for PTSD • Phase 3/RECOVERY • TNX - 601 – (tianeptine) for depression and PTSD • Phase 1 formulation development study completed • TNX - 1600

  34. Slide 34: Pipeline Summary – by Phase of Development

    © 2019 Tonix Pharmaceuticals Holding Corp. 34 Pipeline Summary – by Phase of Development Two Phase 3 Programs in indications affecting millions of Americans • TNX - 102 SL for PTSD: affects an estimated 12 million adults in U.S. • TNX - 102 SL for Fibromyalgia: affects an estimated 6 - 12 million ad

  35. Slide 35: Thank you!

    © 2019 Tonix Pharmaceuticals Holding Corp. 35 Thank you ! NASDAQ: TNXP

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