Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Biotech Showcase January 2024

34 slides from Tonix Pharmaceuticals's conference presentation, Jan 8, 2024

  1. Slide 1: Biotech Showcase Focus on TNX-102 SL for Fibromyalgia

    © 2024 Tonix Pharmaceuticals Holding Corp. Biotech Showcase Focus on: TNX - 102 SL in Development for the Management of Fibromyalgia January 2024 NASDAQ: TNXP Version P0519 January 5 , 2024 (Doc 1365 )

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

    2 © 2024 Tonix Pharmaceuticals Holding Corp. 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: CNS-Focused Biopharma with Preclinical, Clinical and Commercial Stage Products

    3 © 2024 Tonix Pharmaceuticals Holding Corp. CNS - Focused Biopharma with Preclinical, Clinical and Commercial Stage Products Marketed Products • Zembrace ® and Tosymra ® indicated for the treatment of acute migraine TNX - 102 SL for Fibromyalgia: Preparing New Drug Application (NDA) • Two positive

  4. Slide 4: Key Clinical Programs

    4 © 2024 Tonix Pharmaceuticals Holding Corp. Key Clinical Programs *All of Tonix’s product candidates are investigational new drugs or biologics and none has been approved for any indication. NDA Submission Phase 3 Phase 2 Phase 1 Indication Molecule * Fibromyalgia TNX - 102 SL Cyclobenzaprine HCl P

  5. Slide 5: Unique MOA Facilitates Restorative Sleep

    TNX - 102 SL: Unique MOA Facilitates Restorative Sleep Centrally Acting Analgesic 5 Potent binding and antagonist activities at four key receptors facilitate restorative sleep • serotonergic - 5 - HT2A • adrenergic - α1 • histaminergic - H1 • muscarinic - M1 Relative to Oral Cyclobenzaprine o Lower

  6. Slide 6: About Fibromyalgia

    6 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CNS PORTFOLIO Fibromyalgia a fflicts an estimated 6 - 12 million adults in the US, predominantly women 1 1 American Chronic Pain Association (www.theacpa.org, 2019) 2 Robinson et al, Pain Medicine 2013;14:1400 3 The three drugs with FDA appr

  7. Slide 7: Fibromyalgia Program Status

    7 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fibromyalgia Program Status Fibromyalgia TNX - 102 SL Cyclobenzaprine Protectic ® Sublingual Tablets Positive 2 nd Phase 3 Topline Results Reported 4Q’23 1) P ositive Phase 3 study ( RELIEF ) reported – December 2020 1 2) Second Phase 3 stud

  8. Slide 8: Phase 3 RESILIENT Study Design

    8 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: Phase 3 RESILIENT Study Design General s tudy c haracteristics: • Randomized, double - blind, multicenter, placebo - controlle d study in fibromyalgia • 33 U.S. sites enrolled 457 participants with fibromyalgia as defined by 20

  9. Slide 9: RESILIENT Primary Outcome Measure: Reduction in Widespread Pain

    9 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Weekly Average of Daily Diary NRS Ratings of Average Pain Over Prior 24 Hours RESILIENT Primary Outcome Measure Reduction in Widespread Pain -2.2 -2 -1.8 -1.6 -1.4 -1.2 -1 -0.8 -0.6 -0.4 -0.2 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 LS Mean (SE)

  10. Slide 10: Pre-Specified Primary Endpoint Summary

    10 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT Pre - Specified Primary Endpoint Summary • TNX - 102 SL demonstrated statistically significant improvement in mean weekly pain scores over placebo at Week 14 • P - value of 0.00005 is highly statistically significant Additional Fi

  11. Slide 11: Continuous Pain Responder Graph

    11 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT Continuous Pain Responder Graph # Analyses: Pearson’s Chi Squared test for equality of proportions Abbreviations: CI, confidence interval; DIP, difference in proportions ^pre - specified analyses but not key secondary analyses P e

  12. Slide 12: Summary of Key Pre-Specified Secondary Outcome Measures

    12 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Summary of Key Pre - Specified Secondary Outcome Measures *In order of statistical serial gate - keeping hierarchy (or, “waterfall”) to control overall Type 1 error **Statistical significance met Met** Week 14 Rating Scale  p < 0.001 Patie

  13. Slide 13: Patient Global Impression of Change

    13 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT Patient Global Impression of Change Key Secondary Outcome Measure Week 14 TNX - 102 SL responders 35.1%, and placebo responders 19.1%; difference in proportions (95% CI) 16% (7.9%, 24.0%); p=0.00013 # # Based on a Pearson Chi - Sq

  14. Slide 14: FIQ-R Symptoms Domain

    14 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT FIQ - R Symptoms Domain Key Secondary Outcome Measure * *** *** *** Week 14 LS mean (SE) change from baseline for TNX - 102 SL - 16.0 (1.17) and for placebo - 8.4 (1.17); LSMD from placebo - 7.7 (1.62) ; p=0.000002 # # Based on Mi

  15. Slide 15: FIQ-R Function Domain

    15 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT FIQ - R Function Domain Key Secondary Outcome Measure Week 14 LS mean (SE) change from baseline for TNX - 102 SL - 12.2 (1.19) and for placebo - 6.8 (1.21); LSMD from placebo - 5.4 (1.66) ; p=0.001 # # Based on Mixed Model Repeate

  16. Slide 16: PROMIS Sleep Disturbance Inventory

    16 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT PROMIS Sleep Disturbance Inventory Key Secondary Outcome Measure Week 14 LS mean (SE) change from baseline for TNX - 102 SL - 8.4 (0.57) and for placebo - 4.2 (0.56); LSMD from placebo - 4.2 (0.79); p=0.0000001 # # Based on Mixed

  17. Slide 17: PROMIS Fatigue Inventory

    17 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT PROMIS Fatigue Inventory Key Secondary Outcome Measure Week 14 LS mean (SE) change from baseline for TNX - 102 SL - 7.2 (0.55) and for placebo - 4.2 (0.56); LSMD from placebo - 3.0 (0.77); p=0.00009 # # Based on Mixed Model Repeat

  18. Slide 18: RESILIENT Sleep Quality by Daily Diary

    18 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Week 14 LS mean (SE) change from baseline for TNX - 102 SL - 1.77 (0.12) and for placebo - 1.20 (0.12); LSMD from placebo - 0.57 (0.17); p=0.0007 # RESILIENT Sleep Quality by Daily Diary Key Secondary Outcome Measure Weekly Average of Daily

  19. Slide 19: Safety Summary

    19 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT Safety Summary Total* N=457 Placebo N=226 TNX - 102 SL N=231 System Organ Class Preferred Term Oral Cavity Adverse Events 56 (12.3%) 1 (0.4%) 55 (23.8%) Hypoaesthesia oral 29 (6.3%) 2 (0.9%) 27 (11.7%) Product taste abnormal 18 (3

  20. Slide 20: CSFQ-Females Safety Measure

    20 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT CSFQ - 14 Females Safety Measure Pleasure Desire/Frequency Desire/Interest Arousal/Excitement Orgasm/Completion Desire Total Total Score 0.1 [ - 0.0, 0.30] [192/201] 0.3 [0.10, 0.5] [192/204] 0.0 [ - 0.3, 0.4] [192/204] 0.3 [ - 0.

  21. Slide 21: Systolic Blood Pressure Safety Measure

    21 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT Systolic blood pressure Safety Measure No clinically meaningful difference in mean systolic blood pressure between groups Week 14 mean (SD) change from baseline: TNX - 102 SL = 0.7 (12.38) mmHg P lacebo = 0.5 (10.42) mmHg Horizont

  22. Slide 22: Diastolic Blood Pressure Safety Measure

    22 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT Diastolic blood pressure Safety Measure No clinically meaningful difference in mean diastolic blood pressure between groups Week 14 mean (SD) change from baseline: TNX - 102 SL = 1.1 ( 8.60 ) mmHg P lacebo = 0.2 ( 8.22 ) mmHg Hori

  23. Slide 23: Weight Safety Measure

    23 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT Weight Safety Measure No clinically meaningful difference in mean weight between treatment groups Week 14 mean (SD) change from baseline: TNX - 102 SL = 0.02 (2.94 0 ) kg P lacebo = 0.20 (2.932) kg Horizontal lines are the mean fo

  24. Slide 24: Fibromyalgia: Market Characteristics

    24 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fibromyalgia: Market Characteristics Prevalence • One of the more common chronic pain disorders (2 - 4% of US Population) 1 Diagnosed population • Large population but underdiagnosed 2 relative to prevalence rate • Majority receive drug tre

  25. Slide 25: Fewer than Half of Those Treated Receive Sustained Benefit from Approved Drugs

    25 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fewer than Half of Those Treated for Fibromyalgia Receive Sustained Benefit from the Three FDA - Approved Drugs 1 Respond, but intolerant of side effects Do not respond 25% 35% 60% fa il ure rate 1 The three drugs with FDA approval for the

  26. Slide 26: Large Need for New Fibromyalgia Therapies

    26 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO 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 altoge

  27. Slide 27: Tonix Medicines: Commercial-Stage Specialty Pharma Subsidiary

    27 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tonix Medicines: Commercial - Stage Specialty Pharma Subsidiary • Tonix Medicines is a w holly - owned subsidiary of Tonix ( NASDAQ: TNXP) • Currently marketing two products indicated for the treatment of acute migraine: Zembrace ® SymTouch

  28. Slide 28: Patents and Patent Applications

    28 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: Patents and Patent Applications • U.S. Composition:* • A 75:25 cyclobenzaprine HCl - mannitol eutectic (dependent claims add a basifying agent). • 5 US Patents (Expire November 2034) • 1 Pending US Application (Would expire No

  29. Slide 29: Profile Development Program

    29 © 2024 Tonix Pharmaceuticals Holding Corp. PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 102 SL*: Fibromyalgia Cyclobenzaprine Protectic ® Sublingual Tablets Fibromyalgia (FM) is a chronic pain disorder resulting from amplified sensory and pain signaling within the CNS • Afflicts an estimated

  30. Slide 30: Thank You

    © 2024 Tonix Pharmaceuticals Holding Corp. THANK YOU

  31. Slide 31: Zembrace Important Safety Information (1 of 2)

    31 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Zembrace ® Important Safety Information (1 of 2) Zembrace SymTouch ( Zembrace ) can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs

  32. Slide 32: Zembrace Important Safety Information (2 of 2)

    32 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Zembrace ® Important Safety Information (2 of 2) Zembrace may cause serious side effects including: • Changes in color or sensation in your fingers and toes; sudden or severe stomach pain, stomach pain after meals, weight loss, na usea or v

  33. Slide 33: Tosymra Important Safety Information (1 of 2)

    33 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tosymra® Important Safety Information (1 of 2) Tosymra® can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop Tosymra and get emergency medical help if you have any signs of heart att

  34. Slide 34: Tosymra Important Safety Information (2 of 2)

    34 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tosymra may cause serious side effects including: • Changes in color or sensation in your fingers and toes; sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea,

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