Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — IPO Roadshow (February 2020)

31 slides from Tonix Pharmaceuticals's IPO roadshow presentation, Feb 5, 2020

  1. Slide 1: Investor Presentation – Issuer Free Writing Prospectus

    © 2020 Tonix Pharmaceuticals Holding Corp. 1 February 2020 Version P0220 2 - 5 - 20 (Doc 0593) Investor Presentation Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration No. 333 - 235976

  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: Free Writing Prospectus Statement

    © 2020 Tonix Pharmaceuticals Holding Corp. 3 Free Writing Prospectus Statement This presentation highlights basic information about us and the offering to which this communication relates. Because it is a summary, it does not contain all of the information that you should consider before investing i

  4. Slide 4: Tonix Pharmaceuticals: Lead Program SL for Fibromyalgia

    © 2020 Tonix Pharmaceuticals Holding Corp. 4 Tonix Pharmaceuticals: Lead Program In Phase 3 clinical development of TNX - 102 SL 1 for Fibromyalgia • Chronic pain condition Fibromyalgia milestones ( Phase 3 RELIEF study ): • 2 nd Half 2020 - Interim analysis results expected • 1 st Half 2021 - Topli

  5. Slide 5: CNS Candidates in Clinical Development

    © 2020 Tonix Pharmaceuticals Holding Corp. 5 CNS Candidates in Clinical Development Pain, Psychiatry and Addiction Phase 2 NDA 2 /BLA 3 Market Pipeline Product Indication Phase 3 TNX - 102 SL 1 Daytime treatment for PTSD TNX - 601 CR 6 TNX - 1300 5 Cocaine Intoxication / Overdose Cyclobenzaprine HCl

  6. Slide 6: Preclinical Pipeline

    © 2020 Tonix Pharmaceuticals Holding Corp. 6 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

  7. Slide 7: SL: Sublingual Cyclobenzaprine Formulation

    © 2020 Tonix Pharmaceuticals Holding Corp. 7 TNX - 102 SL TNX - 102 SL • Novel sublingual formulation of cyclobenzaprine HCl 1 designed for long - term daily use at bedtime • Rapid absorption • Transmucosal absorption bypasses first pass liver metabolism • Dynamic pharmacokinetic profile with increa

  8. Slide 8: SL 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: Fibromyalgia Overview

    © 2020 Tonix Pharmaceuticals Holding Corp. 9 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 widespread pain, non - restorative sleep, fatigue, diminished cognition

  10. Slide 10: Large Need for New Fibromyalgia Therapies

    © 2020 Tonix Pharmaceuticals Holding Corp. 10 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 • A tt

  11. Slide 11: Potential Role of Sleep Quality in Fibromyalgia

    © 2020 Tonix Pharmaceuticals Holding Corp. 11 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 Believed to result from inappropriate pain signaling in central nervous system • Absen

  12. Slide 12: Phase 3 F301/AFFIRM Study Results of SL 2.8 mg in Fibromyalgia

    © 2020 Tonix Pharmaceuticals Holding Corp. 12 Phase 3 F301/AFFIRM 1 Study Results of TNX - 102 SL 2.8 mg in Fibromyalgia Efficacy analyses: • Primary endpoint (30% responder analysis), p=0.095 • Key Secondary Endpoint: mean pain improvement after 12 weeks of treatment) (MMRM statistical method), p<

  13. Slide 13: AFFIRM Mean Pain Analyzed by MMRM, with and without Multiple Imputation

    © 2020 Tonix Pharmaceuticals Holding Corp. 13 *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

  14. Slide 14: SL for Fibromyalgia: New Phase 3 Study, Higher Dose, New Primary Endpoint

    © 2020 Tonix Pharmaceuticals Holding Corp. 14 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 collected in PTSD studies expected to support fib

  15. Slide 15: SL 5.6 mg for Fibromyalgia: New Phase 3 F304/RELIEF Study Enrolling

    © 2020 Tonix Pharmaceuticals Holding Corp. 15 TNX - 102 SL 5.6 mg for Fibromyalgia: New Phase 3 F304/RELIEF 1 Study Enrolling 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 rati

  16. Slide 16: Common Adverse Events Related to SL in Prior PTSD Studies

    © 2020 Tonix Pharmaceuticals Holding Corp. 16 Common Adverse Events (AEs) Related to TNX - 102 SL in prior Posttraumatic Stress Disorder (PTSD) Studies No serious and unexpected AEs related to TNX - 102 SL • Systemic AEs comparable between studies and also consistent with those described in approved

  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: SL: Potential Treatment for Agitation in Alzheimer's Disease

    © 2020 Tonix Pharmaceuticals Holding Corp. 18 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

  19. Slide 19: SL: Potential Treatment for Alcohol Use Disorder

    © 2020 Tonix Pharmaceuticals Holding Corp. 19 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

  20. Slide 20: TNX-1300 for the Treatment of Cocaine Intoxication

    © 2020 Tonix Pharmaceuticals Holding Corp. 20 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

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

    © 2020 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 CR Tianeptine Oxalate Controlled Release Tablets

    © 2020 Tonix Pharmaceuticals Holding Corp. 23 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

  24. Slide 24: TNX-601 CR: Potential Daytime Treatment for Depression and PTSD

    © 2020 Tonix Pharmaceuticals Holding Corp. 24 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

  25. Slide 25: TNX-801: Potential Smallpox and Monkeypox Preventing Vaccine

    © 2020 Tonix Pharmaceuticals Holding Corp. 25 TNX - 801 (Synthesized Live Horsepox Virus): A Potential Smallpox and Monkeypox Preventing Vaccine Pre - IND Stage Potential improvement over current biodefense tools against smallpox ✓ Demonstrated protective vaccine activity in mice and macaques ✓ Coll

  26. Slide 26: No Overt Clinical Signs in TNX-801 Vaccinated Macaques After MPXV Challenge

    26 © 2020 Tonix Pharmaceuticals Holding Corp. No Overt Clinical Signs Observed in TNX - 801 Vaccinated Macaques After MPXV Challenge 1 1 Noyce, RS, et al. Synthetic Chimeric Horsepox Virus ( scHPXV ) Vaccination Protects Macaques from Monkeypox* Presented as a poster at the American Society of Micro

  27. Slide 27: Pipeline Summary – by Select Therapeutic Areas

    © 2020 Tonix Pharmaceuticals Holding Corp. 27 Pipeline Summary – by Select Therapeutic Areas Pain Psychiatry Addiction Medicine Biodefense • TNX - 102 SL – (sublingual cyclobenzaprine) for fibromyalgia Phase 3/RELIEF • TNX - 102 SL – (sublingual cyclobenzaprine) for agitation in Alzheimer’s Phase 2

  28. Slide 28: Milestones – Recently Completed and Upcoming

    © 2020 Tonix Pharmaceuticals Holding Corp. 28 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

  29. Slide 29: Management Team

    © 2020 Tonix Pharmaceuticals Holding Corp. 29 Management Team Seth Lederman, MD President & CEO Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger, CPA Chief Financial Officer

  30. Slide 30: Financial Overview

    © 2020 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 January 13, 2020 8.5 million shares

  31. Slide 31: Thank you!

    © 2020 Tonix Pharmaceuticals Holding Corp. 31 Thank you ! NASDAQ: TNXP

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