Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (April 2020)

38 slides from Tonix Pharmaceuticals's investor presentation, Apr 20, 2020

  1. Slide 1: Investor Presentation, April 2020

    © 2020 Tonix Pharmaceuticals Holding Corp. 1 April 2020 Version P0226 4 - 20 - 20 (Doc 0620) 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 Programs

    © 2020 Tonix Pharmaceuticals Holding Corp. 3 Tonix Pharmaceuticals: Lead Programs 1 TNX - 1800 potential vaccine for COVID - 19 2,3 • Pre - clinical stage • Live virus vaccine designed on our horsepox vaccine platform 4 to express the SARS - CoV - 2 Spike (S) protein • Milestones: • 3 rd Quarter 202

  4. Slide 4: Public Health and Biodefense Preclinical Pipeline

    © 2020 Tonix Pharmaceuticals Holding Corp. 4 Public Health and Biodefense Preclinical Pipeline 1 1 Experimental new medicines and biologics, not approved for any indication 2 Collaboration with Southern Research 3 Designed to express SARS - CoV - 2 Spike (S) protein 4 COVID - 19 = Coronavirus diseas

  5. Slide 5: TNX-801: A Potential Smallpox and Monkeypox Preventing Vaccine

    © 2020 Tonix Pharmaceuticals Holding Corp. 5 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 ✓ Colla

  6. Slide 6: Dr. Edward Jenner's Inquiry (1798)

    © 2020 Tonix Pharmaceuticals Holding Corp. 6 Dr. 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 possessi

  7. Slide 7: Relationship Between Horsepox, Certain Vaccinia Strains and Variola

    © 2020 Tonix Pharmaceuticals Holding Corp. 7 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 ).

  8. Slide 8: No Overt Clinical Signs Observed in TNX-801-Vaccinated Macaques After MPXV Challenge

    8 © 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 Microb

  9. Slide 9: TNX-801 live horsepox virus vaccine

    © 2020 Tonix Pharmaceuticals Holding Corp. 9 TNX - 801 (live horsepox virus vaccine for percutaneous (scarification) administration) Vaccine based on sequence of isolated horsepox clone 1,2 • No new gene elements and coding sequence is identical to environmental horsepox isolate • May be considered

  10. Slide 10: Potential for Use of Horsepox as a Vector Platform for other Infectious Diseases

    © 2020 Tonix Pharmaceuticals Holding Corp. 10 Potential for Use of Horsepox as a Vector Platform for other 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 antig

  11. Slide 11: TNX-1800 Is Designed to Express SARS-CoV-2 Spike Protein

    © 2020 Tonix Pharmaceuticals Holding Corp. 11 TNX - 1800 Is Designed to Express SARS - CoV - 2 Spike Protein *TNX - 1800 is at the pre - IND stage of development Horsepox sHPXV ~200,000 Bp TNX - 1800 * rHPXV/SARS - CoV - 2S ~200,000 Bp Homologous Recombination

  12. Slide 12: Potential for Use of Horsepox as a Vector Platform for a SARS-CoV-2 Vaccine

    © 2020 Tonix Pharmaceuticals Holding Corp. 12 Potential for Use of Horsepox as a Vector Platform for a SARS - CoV - 2 Vaccine Strong immunogenicity for adaptive and innate immunity – believed important in SARS • Humoral immunity against Spike protein is sufficient to protect against SARS - CoV in mi

  13. Slide 13: CNS Candidates in Clinical Development

    © 2020 Tonix Pharmaceuticals Holding Corp. 13 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 7 TNX - 1300 6 Cocaine Intoxication / Overdose Cyclobenzaprine HC

  14. Slide 14: TNX-102 SL

    © 2020 Tonix Pharmaceuticals Holding Corp. 14 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 incre

  15. Slide 15: TNX-102 SL Intellectual Property – Patent Protection expected until 2035

    © 2020 Tonix Pharmaceuticals Holding Corp. 15 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 exp

  16. Slide 16: Fibromyalgia

    © 2020 Tonix Pharmaceuticals Holding Corp. 16 Fibromyalgia Fibromyalgia is considered a neurobiological disorder characterized by 1 : chronic widespread pain, non - restorative sleep, fatigue, diminished cognition Believed to result from inappropriate pain signaling in central nervous system in the

  17. Slide 17: Large Need for New Fibromyalgia Therapies

    © 2020 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 High rates of discontinuation, switching and augmentation • A tt

  18. Slide 18: Potential Role of Sleep Quality in Fibromyalgia

    © 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 Believed to result from inappropriate pain signaling in central nervous system • Absen

  19. Slide 19: Phase 3 F301/AFFIRM Study Results of TNX-102 SL 2.8 mg in Fibromyalgia

    © 2020 Tonix Pharmaceuticals Holding Corp. 19 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<

  20. Slide 20: AFFIRM Study Results: Mean Pain Analyzed by MMRM, with and without Multiple Imputation

    © 2020 Tonix Pharmaceuticals Holding Corp. 20 *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

  21. Slide 21: TNX-102 SL for Fibromyalgia: New Phase 3 Study

    © 2020 Tonix Pharmaceuticals Holding Corp. 21 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

  22. Slide 22: Common Adverse Events Related to TNX-102 SL in prior PTSD Studies

    © 2020 Tonix Pharmaceuticals Holding Corp. 22 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

  23. Slide 23: TNX-102 SL 5.6 mg for Fibromyalgia: New Phase 3 F304/RELIEF Study Enrolling

    © 2020 Tonix Pharmaceuticals Holding Corp. 23 1 C inicalTrials.gov Identifier: NCT04172831 2 Two week run in at 2.8 mg dose at bedtime, followed by 12 weeks at 5.6 mg dose 3 We cannot predict whether the global COVID - 19 pandemic will impact the timing of these milestones TNX - 102 SL 5.6 mg for Fi

  24. Slide 24: Summary of PTSD Clinical Trials with TNX-102 SL

    © 2020 Tonix Pharmaceuticals Holding Corp. 24 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

  25. Slide 25: TNX-102 SL for PTSD: Phase 3 P302/RECOVERY Study

    © 2020 Tonix Pharmaceuticals Holding Corp. 25 1 ClinicalTrials.gov Identifier: NCT03841773 2 CAPS - 5 = Clinician - Administered PTSD Scale for DSM - 5 3 Target enrollment – enrollment stopped at less than 250 after interim analysis 4 We cannot predict whether the global COVID - 19 pandemic will imp

  26. Slide 26: Opportunities to Expand to Other Indications

    © 2020 Tonix Pharmaceuticals Holding Corp. 26 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

  27. Slide 27: TNX-102 SL: Potential Treatment for Agitation in Alzheimer's Disease

    © 2020 Tonix Pharmaceuticals Holding Corp. 27 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

  28. Slide 28: TNX-102 SL: Potential Treatment for Alcohol Use Disorder

    © 2020 Tonix Pharmaceuticals Holding Corp. 28 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

  29. Slide 29: TNX-1300 for the Treatment of Cocaine Intoxication

    © 2020 Tonix Pharmaceuticals Holding Corp. 29 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 a bacterium ( Rhodococcus ) that use cocaine as its sole source of c

  30. Slide 30: TNX-1300 Is a Fast-acting Cocaine Antidote

    © 2020 Tonix Pharmaceuticals Holding Corp. 30 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

  31. Slide 31: 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

  32. Slide 32: TNX-601 CR (Tianeptine Oxalate Controlled Release) Tablets

    © 2020 Tonix Pharmaceuticals Holding Corp. 32 TNX - 601 CR 1 (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

  33. Slide 33: TNX-601 CR: A Potential Daytime Treatment for Depression and PTSD

    © 2020 Tonix Pharmaceuticals Holding Corp. 33 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

  34. Slide 34: Psychiatry, Immunology and Oncology Preclinical Pipeline

    © 2020 Tonix Pharmaceuticals Holding Corp. 34 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 - 2

  35. Slide 35: Pipeline Summary – by Select Therapeutic Areas

    © 2020 Tonix Pharmaceuticals Holding Corp. 35 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

  36. Slide 36: Milestones – Recently Completed and Upcoming

    © 2020 Tonix Pharmaceuticals Holding Corp. 36 Milestones – Recently Completed and Upcoming 1 □ 4 th Quarter 2019 Confirmed once - daily dosing for TNX - 601 CR in PK study □ 4 th Quarter 2019 Enrolled first patient in TNX - 102 SL Phase 3 F304/RELIEF study for management of fibromyalgia □ February 2

  37. Slide 37: Management Team

    © 2020 Tonix Pharmaceuticals Holding Corp. 37 Management Team Seth Lederman, MD President & CEO Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger, CPA Chief Financial Officer

  38. Slide 38: Thank you!

    © 2020 Tonix Pharmaceuticals Holding Corp. 38 Thank you ! NASDAQ: TNXP

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