Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (March 2020)

40 slides from Tonix Pharmaceuticals's investor presentation, Mar 3, 2020

  1. Slide 1: Investor Presentation March 2020

    © 2020 Tonix Pharmaceuticals Holding Corp. 1 March 2020 Version P0222 2 - 28 - 20 (Doc 0604) 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: Lead Program in Phase 3 for Fibromyalgia

    © 2020 Tonix Pharmaceuticals Holding Corp. 3 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 ): • 3 rd Quarter 2020 - Interim analysis results expected • 1 st Half 2021 - To

  4. Slide 4: CNS Candidates in Clinical Development

    © 2020 Tonix Pharmaceuticals Holding Corp. 4 CNS Candidates in Clinical Development Pain, Psychiatry and Addiction Phase 1 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

  5. Slide 5: Public Health and Biodefense Preclinical Pipeline

    © 2020 Tonix Pharmaceuticals Holding Corp. 5 Public Health and Biodefense Preclinical Pipeline 1 1 Experimental new medicines and biologics, not approved for any indication 2 COVID - 19 = Coronavirus disease 2019 3 Programs owned outright with no royalties due 4 R ecombinant Trefoil Family Factor 2

  6. Slide 6: Psychiatry, Immunology and Oncology Preclinical Pipeline

    © 2020 Tonix Pharmaceuticals Holding Corp. 6 Psychiatry, Immunology and Oncology 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

  7. Slide 7: TNX-102 SL sublingual cyclobenzaprine

    © 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: TNX-102 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 and burden

    © 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 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 Analysis 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: 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: Common Adverse Events Related to TNX-102 SL in PTSD Studies

    © 2020 Tonix Pharmaceuticals Holding Corp. 15 Common Adverse Events (AEs) Related to TNX - 102 SL in prior Posttraumatic Stress Disorder (PTSD) Studies AE profiles are comparable between fibromyalgia and PTSD studies • Tolerability of TNX - 102 SL 2.8 mg in two fibromyalgia studies (F201 and F301) c

  16. Slide 16: TNX-102 SL 5.6 mg: Phase 3 F304/RELIEF Study Enrolling

    © 2020 Tonix Pharmaceuticals Holding Corp. 16 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

  17. Slide 17: Summary of PTSD Clinical Trials with TNX-102 SL

    © 2020 Tonix Pharmaceuticals Holding Corp. 17 Summary of PTSD Clinical Trials with TNX - 102 SL Phase 2 “ AtEase Study” (P201)(Military population) • 2.8 mg and 5.6 mg treatment doses • Not significant on primary endpoint • Median Time Since Index Trauma - 6.0 years • Stronger activity observed at 5

  18. Slide 18: PTSD: Phase 3 P302/RECOVERY Study

    © 2020 Tonix Pharmaceuticals Holding Corp. 18 TNX - 102 SL for PTSD: Phase 3 P302/RECOVERY 1 Study Expecting Topline Results in 3Q 2020 Interim Analysis Result was Futility • Unlikely to reach statistical significance on primary endpoint based on first 127 patients randomized • Enrollment stopped •

  19. Slide 19: Opportunities to Expand to Other Indications

    © 2020 Tonix Pharmaceuticals Holding Corp. 19 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

  20. Slide 20: Potential Treatment for Agitation in Alzheimer's Disease

    © 2020 Tonix Pharmaceuticals Holding Corp. 20 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

  21. Slide 21: Potential Treatment for Alcohol Use Disorder

    © 2020 Tonix Pharmaceuticals Holding Corp. 21 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

  22. Slide 22: TNX-1300 for the Treatment of Cocaine Intoxication

    © 2020 Tonix Pharmaceuticals Holding Corp. 22 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

  23. Slide 23: TNX-1300 Is a Fast-acting Cocaine Antidote

    © 2020 Tonix Pharmaceuticals Holding Corp. 23 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

  24. Slide 24: Cocaine Intoxication Is a Growing Problem in the U.S.

    © 2020 Tonix Pharmaceuticals Holding Corp. 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 h

  25. Slide 25: TNX-601 CR Tianeptine Oxalate Controlled Release Tablets

    © 2020 Tonix Pharmaceuticals Holding Corp. 25 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

  26. Slide 26: TNX-601 CR: Potential Daytime Treatment for Depression and PTSD

    © 2020 Tonix Pharmaceuticals Holding Corp. 26 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

  27. Slide 27: TNX-801: Potential Smallpox and Monkeypox Preventing Vaccine

    © 2020 Tonix Pharmaceuticals Holding Corp. 27 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

  28. Slide 28: Edward Jenner's Inquiry (1798)

    © 2020 Tonix Pharmaceuticals Holding Corp. 28 Edward Jenner’s Inquiry (1798) 1 “There is a disease to which the Horse from his state of domestication is frequently subject. The Farriers have termed it the Grease . It is an inflammation and swelling in the heel, from which issues matter 2 possessing

  29. Slide 29: Edward Jenner's Inquiry (1798) – Cow Pox

    © 2020 Tonix Pharmaceuticals Holding Corp. 29 Edward Jenner’s Inquiry (1798) 1 - 2 “In this Dairy Country a great number of Cows are kept, and the office of milking is performed indiscriminately by Men and Maid Servants. One of the former having been appointed to apply dressings to the heels of a Ho

  30. Slide 30: Relationship Between Horsepox, Vaccinia Strains and Variola

    © 2020 Tonix Pharmaceuticals Holding Corp. 30 Relationship Between Horsepox, Certain Vaccinia Strains and Variola Legend: Alignment of orthopoxvirus genomes and location of horsepox (HPXV) genes within telomeres. Orthopoxvirus genomes were aligned using the program GView ( https://server.gview.ca ).

  31. Slide 31: Feral Vaccinia – No Horsepox Reported in >40 Years

    31 Modern vaccinia (VACV) strains have demonstrated potential for re - infecting animals and subsequently infecting humans 1 - 4 • Vaccine virus in Brazil have become established in cattle (Brazil and possibly Columbia 5 ) and buffalos (India) Horsepox has not been reported in >40 years • Improved h

  32. Slide 32: TNX-801 live horsepox virus vaccine

    © 2020 Tonix Pharmaceuticals Holding Corp. 32 TNX - 801 (live horsepox virus vaccine for percutaneous (scarification) administration) Vaccine based on sequence of isolated horsepox clone 1 • Synthesized 2 , since 1976 isolate is not available outside of U.S. Centers for Disease Control and Preventio

  33. Slide 33: No Overt Clinical Signs in TNX-801 Vaccinated Macaques After MPXV Challenge

    33 © 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

  34. Slide 34: Potential Advantages of TNX-801

    © 2020 Tonix Pharmaceuticals Holding Corp. 34 Potential Advantages of TNX - 801 Potential tolerability in humans • Reduced plaque size and toxicity in mice 1 are likely multi - genic and are not currently understood Historical evidence for horsepox - like vaccines • Jenner and others demonstrated th

  35. Slide 35: Horsepox as a Vector Platform for Vaccines

    © 2020 Tonix Pharmaceuticals Holding Corp. 35 Potential for Use of Horsepox as a Vector Platform for Vaccines to Infectious Diseases Horsepox can be engineered to express foreign genes and serve as a platform for vaccine development • Large packaging capacity for exogenous DNA inserts (i.e. encoding

  36. Slide 36: TNX-1800: A Potential Vaccine for COVID-19

    © 2020 Tonix Pharmaceuticals Holding Corp. 36 TNX - 1800 1 (Live Modified Horsepox Virus): A Potential Vaccine for COVID - 19 Pre - IND Stage Potential vaccine that utilizes Tonix’s proprietary horsepox virus as a vector ✓ Designed to express protein from SARS - CoV - 2, the cause of COVID - 19 ✓ Co

  37. Slide 37: Pipeline Summary – by Select Therapeutic Areas

    © 2020 Tonix Pharmaceuticals Holding Corp. 37 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 PTSD Phase 3/RECOVERY FDA Breakth

  38. Slide 38: Milestones – Recently Completed and Upcoming

    © 2020 Tonix Pharmaceuticals Holding Corp. 38 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

  39. Slide 39: Management Team

    © 2020 Tonix Pharmaceuticals Holding Corp. 39 Management Team Seth Lederman, MD President & CEO Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger, CPA Chief Financial Officer

  40. Slide 40: Thank you!

    © 2020 Tonix Pharmaceuticals Holding Corp. 40 Thank you ! NASDAQ: TNXP

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