Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (January 2020)

34 slides from Tonix Pharmaceuticals's investor presentation, Jan 6, 2020

  1. Slide 1: Investor Presentation January 2020

    © 2020 Tonix Pharmaceuticals Holding Corp. 1 January 2020 Version P0214 1 - 6 - 20 (Doc 0579) Investor Presentation

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

    © 2020 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

    © 2020 Tonix Pharmaceuticals Holding Corp. 3 Tonix Pharmaceuticals Who we are: • A clinical stage biopharmaceutical company dedicated to developing innovative treatments for psychiatric, pain and addiction conditions What we do: • Target therapeutic areas with high need for improvement − Conditions

  4. Slide 4: Management Team

    © 2020 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: Financial Overview

    © 2020 Tonix Pharmaceuticals Holding Corp. 5 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 January 1, 2020 8.5 million shares

  6. Slide 6: CNS Candidates in Clinical Development

    © 2020 Tonix Pharmaceuticals Holding Corp. 6 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

  7. Slide 7: Preclinical Pipeline

    © 2020 Tonix Pharmaceuticals Holding Corp. 7 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 o

  8. Slide 8: Intellectual Property – Patent Protection expected until 2035

    © 2020 Tonix Pharmaceuticals Holding Corp. 8 TNX - 102 SL Intellectual Property – Patent Protection expected until 2035 Composition of matter (eutectic): protection expected to 2034/2035 10 patents issued worldwide; 35 patent applications pending Composition of matter (sublingual): protection expect

  9. Slide 9: Prevalence of PTSD Among Civilians and Veterans

    © 2020 Tonix Pharmaceuticals Holding Corp. 9 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

  10. Slide 10: Unmet Need for Effective and Safe Therapies for Treatment of PTSD

    © 2020 Tonix Pharmaceuticals Holding Corp. 10 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 effec

  11. Slide 11: Potential Therapeutic Advantages of Tonmya

    © 2020 Tonix Pharmaceuticals Holding Corp. 11 Potential Therapeutic Advantages of TNX - 102 SL TNX - 102 SL is believed to treat PTSD and fibromyalgia by improving sleep quality, in contrast to sleep quantity • Quality involves restorative properties of sleep • Quantity is time spent asleep • TNX -

  12. Slide 12: Potential Therapeutic Advantages of Tonmya (continued)

    © 2020 Tonix Pharmaceuticals Holding Corp. 12 Potential Therapeutic Advantages of TNX - 102 SL (continued) Cyclobenzaprine, active ingredient of TNX - 102 SL, is NEITHER a benzodiazepine nor a narcotic • Does NOT interact with the same receptors as traditional hypnotic sleep drugs associated with re

  13. Slide 13: Phase 2 Dose-Effect in Military-Related PTSD

    © 2020 Tonix Pharmaceuticals Holding Corp. 13 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

  14. Slide 14: Primary Outcome (CAPS-5) in Phase 3 Study: Retrospective Analysis

    © 2020 Tonix Pharmaceuticals Holding Corp. 14 Primary Outcome (CAPS - 5) in Phase 3 Study: Retrospective Analysis ≤9 Years Time Since Trauma (TST) Subgroup Phase 3 P301/HONOR Study 1 ** p=0.004, # p=0.069, * p=0.039, TNX - 102 SL 5.6 mg group v. placebo, using MMRM with MI ~50% mITT Population, ≤ 9

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

    © 2020 Tonix Pharmaceuticals Holding Corp. 15 Adverse Events (AEs) in P201/AtEase and P301/HONOR Studies No serious and 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 l

  16. Slide 16: Phase 3 P302/RECOVERY Study for PTSD

    © 2020 Tonix Pharmaceuticals Holding Corp. 16 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

  17. Slide 17: Opportunities to Expand to Other Indications

    © 2020 Tonix Pharmaceuticals Holding Corp. 17 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) • Sleep quality plays a homeostatic role in several dis

  18. Slide 18: Fibromyalgia Overview

    © 2020 Tonix Pharmaceuticals Holding Corp. 18 Volkswagen Check Engine [Photograph]. (2011, October 14). Wikipedia When the check engine light malfunctions, the light is on even though the car is not malfunctioning • Fibromyalgia is considered a neurobiological disorder characterized by 1 : chronic w

  19. Slide 19: Large Need for New Fibromyalgia Therapies

    © 2020 Tonix Pharmaceuticals Holding Corp. 19 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 • High rates of discontinuation, switching and augmentation •

  20. Slide 20: Summary of Completed Phase 3 AFFIRM Study (F301)

    © 2020 Tonix Pharmaceuticals Holding Corp. 20 TNX - 102 SL 2.8 mg for Fibromyalgia Summary of Completed Phase 3 AFFIRM Study (F301) MMRM = mixed model repeated measures • 519 patients enrolled in 12 - week, double - blind trial • Randomized 1:1, placebo or TNX - 102 SL 2.8 mg (lowest possible dose),

  21. Slide 21: Phase 3 AFFIRM Study Results: Mean Pain Analysis

    © 2020 Tonix Pharmaceuticals Holding Corp. 21 *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

  22. Slide 22: New Phase 3 Study for Fibromyalgia: Higher Dose, New Primary Endpoint

    © 2020 Tonix Pharmaceuticals Holding Corp. 22 TNX - 102 SL for Fibromyalgia New Phase 3 Study: Higher (2x) Dose, New Primary Endpoint • Clear guidance from FDA to advance fibromyalgia program using higher dose (5.6 mg) • Long - term safety of 5.6 mg dose used in PTSD expected to support fibromyalgia

  23. Slide 23: Phase 3 RELIEF Study Initiated

    © 2020 Tonix Pharmaceuticals Holding Corp. 23 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 as measured by the numerical rating scal

  24. Slide 24: Potential Treatment for Agitation in Alzheimer's Disease

    © 2020 Tonix Pharmaceuticals Holding Corp. 24 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

  25. Slide 25: Potential Treatment for Alcohol Use Disorder

    © 2020 Tonix Pharmaceuticals Holding Corp. 25 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

  26. Slide 26: TNX-1300 for the Treatment of Cocaine Intoxication

    © 2020 Tonix Pharmaceuticals Holding Corp. 26 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

  27. Slide 27: TNX-1300 Is a Fast-acting Cocaine Antidote

    © 2020 Tonix Pharmaceuticals Holding Corp. 27 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

  28. Slide 28: 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

  29. Slide 29: TNX-601 CR Tianeptine Oxalate Controlled Release Tablets

    © 2020 Tonix Pharmaceuticals Holding Corp. 29 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

  30. Slide 30: TNX-601 CR: Potential Daytime Treatment for Depression and PTSD

    © 2020 Tonix Pharmaceuticals Holding Corp. 30 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

  31. Slide 31: Milestones – Recently Completed and Upcoming

    © 2020 Tonix Pharmaceuticals Holding Corp. 31 Milestones – Recently Completed and Upcoming □ May 2019 In - licensed TNX - 1300, in Phase 2 development for cocaine intoxication □ October 2019 Completed long - term exposure studies in PTSD to evaluate tolerability of TNX - 102 SL 5.6 mg □ October 2019

  32. Slide 32: Pipeline Summary – by Select Therapeutic Areas

    © 2020 Tonix Pharmaceuticals Holding Corp. 32 Pipeline Summary – by Select Therapeutic Areas Psychiatry Pain Addiction Medicine Biodefense • TNX - 102 SL – (sublingual cyclobenzaprine) for PTSD Phase 3/RECOVERY FDA Breakthrough Therapy designation • TNX - 102 SL – (sublingual cyclobenzaprine) for ag

  33. Slide 33: Pipeline Summary – by Phase of Development

    © 2020 Tonix Pharmaceuticals Holding Corp. 33 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. – FDA Breakthrough Therapy designation • TNX - 102 SL for Fibromyalgia:

  34. Slide 34: Thank you!

    © 2020 Tonix Pharmaceuticals Holding Corp. 34 Thank you ! NASDAQ: TNXP

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