Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — American Society of Clinical Psychopharmacology Annual Meeting 2024

20 slides from Tonix Pharmaceuticals's conference presentation, Jun 3, 2024

  1. Slide 1: Effects of Bedtime TNX-102 SL on Mood and Anxiety Symptoms in Fibromyalgia

    © 2024 Tonix Pharmaceuticals Holding Corp. Presented by Seth Lederman, MD at American Society of Clinical Psychopharmacology Annual Meeting, Miami, FL May 29, 2024 Effects of Bedtime TNX - 102 SL (Sublingual Cyclobenzaprine HCl) on Mood and Anxiety Symptoms in Fibromyalgia: Results of the Phase 3 RE

  2. Slide 2: Disclosures

    © 2024 Tonix Pharmaceuticals Holding Corp. 2 Disclosures • Authors: Gregory Sullivan 1 , David Hsu 1 , Mary Kelley 1 , Ben Vaughn 2 , Jean Engels 1 and Seth Lederman 1 • 1 Employees of Tonix Pharmaceuticals Holding Corp. and own stock and stock options in the company • 2 Employee of Rho, Inc. • TNX

  3. Slide 3: Characteristics of Fibromyalgia

    © 2024 Tonix Pharmaceuticals Holding Corp. 3 Characteristics of Fibromyalgia • Symptoms include chronic widespread pain , nonrestorative sleep , fatigue , and cognitive dysfunction • Afflicts an estimated 6 - 12 million US adults, majority are women • Those with FM struggle with daily activities, ha

  4. Slide 4: 2016 Fibromyalgia (FM) Criteria

    © 2024 Tonix Pharmaceuticals Holding Corp. 4 2016 Fibromyalgia (FM) Criteria* • How is FM currently diagnosed? By assessing pain distribution and other core symptoms of FM: • Widespread pain index (WPI): number of areas (out of 19) with pain ( WPI range 0 - 19 ) • Symptom severity scale (SSS) score

  5. Slide 5: Fibromyalgia: Nonrestorative Sleep and Cyclobenzaprine

    © 2024 Tonix Pharmaceuticals Holding Corp. 5 Fibromyalgia: Nonrestorative Sleep and Cyclobenzaprine • Non - restorative sleep 1,2 • Harvey Moldofsky – recognition of unrefreshing/non - restorative sleep: • Symptom • P otential causative or potentiating factor • Cyclobenzaprine 3,9 • Potentially the

  6. Slide 6: TNX-102 SL (Sublingual Cyclobenzaprine HCl)

    © 2024 Tonix Pharmaceuticals Holding Corp. 6 TNX - 102 SL (Sublingual Cyclobenzaprine HCl) • Cyclobenzaprine (CBP) is a tricyclic amine close in structure to amitriptyline (AMI)* • CBP with potent binding and antagonist activity at several receptors influencing sleep: 5 - HT 2A serotonergic, α 1 - a

  7. Slide 7: Phase 3 RESILIENT Study of TNX-102 SL in FM

    © 2024 Tonix Pharmaceuticals Holding Corp. 7 Phase 3 RESILIENT Study of TNX - 102 SL in FM Trial TNX - CY - F307 ClinicalTrials.gov Identifier NCT05273749 General s tudy c haracteristics: • Randomized, double - blind, multicenter, placebo - controlle d study in fibromyalgia (FM) • 33 U.S. sites enro

  8. Slide 8: RESILIENT Study Demographics and Baseline Characteristics

    © 2024 Tonix Pharmaceuticals Holding Corp. 8 RESILIENT Study Demographics and Baseline Characteristics ITT Population Demographics TNX - 102 SL Placebo N=231 N=225 Variable 49.3 (10.45) 49.5 (11.35) Age, Years , mean (SD) 224 (97.0%) 211 (93.8%) Sex, Female , N (%) 7 (3.0%) 14 (6.2%) Sex, Male , N (

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

    © 2024 Tonix Pharmaceuticals Holding Corp. 9 RESILIENT Primary Outcome Measure Reduction in Widespread Pain Weekly Average of Daily Diary NRS Ratings of Average Pain Over Prior 24 Hours -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) Change in NRS

  10. Slide 10: RESILIENT Key Secondary Outcome Measures Met

    © 2024 Tonix Pharmaceuticals Holding Corp. 10 RESILIENT Key Secondary Outcome Measures Met** Week 14 p - value Rating Scale*  p = 0.00013 ^ Patient Global Impression of Change (PGIC)  p = 0.000002 # Fibromyalgia Impact Questionnaire - Symptoms  p = 0.001 # Fibromyalgia Impact Questionnaire - Func

  11. Slide 11: RESILIENT Beck Depression Inventory-II Results

    © 2024 Tonix Pharmaceuticals Holding Corp. 11 RESILIENT Beck Depression Inventory - II Results Effect Size P - value 95% CI for Difference Difference in LS Means (SE) TNX LS MCFB (SE) TNX Mean (SD) Placebo LS MCFB (SE) Placebo Mean (SD) 9.6 (6.32) 10.0 (6.72) Baseline 0.27 0.005 # - 2.3, - 0.4 - 1.4

  12. Slide 12: RESILIENT Individual Items on FIQR

    © 2024 Tonix Pharmaceuticals Holding Corp. 12 RESILIENT Individual Items on FIQR Affective Symptoms, Sensory Sensitivity, Cognition, and Energy Selected Fibromyalgia Impact Questionnaire - Revised Symptoms Domain Item Scores Effect Size P - value^ 95% Confidence Interval # Week 14 LS Mean (SE) Diffe

  13. Slide 13: Summary of Baseline Depression BDI-II and FIQR Item Data

    © 2024 Tonix Pharmaceuticals Holding Corp. 13 Summary of Baseline Depression BDI - II and FIQR Item Data • While the rate of current MDE diagnosis was ~2% of the ITT, ~25% ITT had experienced a lifetime MDE, and ~47% reported past 6 month depression on FM Dx* • Also, about 25% of the ITT enrolled on

  14. Slide 14: RESILIENT Safety

    © 2024 Tonix Pharmaceuticals Holding Corp. 14 RESILIENT Safety Total* N=457 Placebo N=226 TNX - 102 SL N=231 System Organ Class Preferred Term Systemic Adverse Events 17 (3.7%) 7 (3.1%) 10 (4.3%) COVID - 19 10 (2.2%) 3 (1.3%) 7 (3.0%) Somnolence 11 (2.4%) 4 (1.8%) 7 (3.0%) Headache Oral Cavity Adver

  15. Slide 15: RESILIENT Analysis by Sensory Adverse Events

    © 2024 Tonix Pharmaceuticals Holding Corp. 15 RESILIENT Analysis by Sensory Adverse Events (AEs) TNX - 102 SL group divided for presence/absence of 3 sensory AEs • AEs of oral numbness, oral tingling, and bitter aftertaste named ‘Sensory AEs’* • Graph shows negligible advantage for presence of senso

  16. Slide 16: RESILIENT Safety, Continued

    © 2024 Tonix Pharmaceuticals Holding Corp. 16 RESILIENT Safety, Continued 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 Placebo = 0.5 (10.42) mmHg No clinically meaningful difference in mean

  17. Slide 17: RESILIENT Safety, Continued

    © 2024 Tonix Pharmaceuticals Holding Corp. 17 RESILIENT Safety, Continued Horizontal lines are the mean for each group; boxes are the 25 th and 75 th percentiles; and vertical lines begin and end at the 5 th and 95 th percentiles Systolic Blood Pressure Across Study Visits Diastolic Blood Pressure A

  18. Slide 18: Tolerability – Sexual Functioning

    © 2024 Tonix Pharmaceuticals Holding Corp. 18 Tolerability – Sexual Functioning • No AEs of sexual dysfunction in RESILIENT • Sexual functioning also systematically investigated using the Changes in Sexual Functioning Questionnaire short form (CSFQ - 14) at Baseline and Week 14 • In females, improve

  19. Slide 19: Conclusions

    © 2024 Tonix Pharmaceuticals Holding Corp. 19 Conclusions • Fibromyalgia diagnostic criteria include depression (past 6 months) as part of the symptom burden, adding a point to symptom severity scale (SSS) score • Depressive severity reported to be prominent factor for quality of life in FM • Phase

  20. Slide 20: Thank you! Questions?

    © 2024 Tonix Pharmaceuticals Holding Corp. Thank you ! Questions?

Tonix Pharmaceuticals Holding — American Society of Clinical Psychopharmacology Annual Meeting 2024 on 6ix