Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — ACR Convergence 2021
20 slides from Tonix Pharmaceuticals's conference presentation, Nov 8, 2021
Slide 1: TNX-102 SL for the Treatment of Fibromyalgia in the RELIEF Study
ACR Convergence ‘Where Rheumatology Meets TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia in the RELIEF Study Positive Results of a Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Efficacy and Safety Trial Gregory Sullivan MD Tonix Pharmaceutical Inc
Slide 2: Disclosures
AMERICAN COLLEGE. ef RHEUMATOLOGY Capring Renal Pia Disclosures Presenting author Gregory Sullivan MD is an officer of Tonix Pharmaceuticals Inc (Tonix) Dr. Sullivan holds stock and stock options in Tonix Tonix owns composition of matter and use patents for the investigational product in the RELIEF
Slide 3: Evidence-Based Medicine Key References
“AMERICAN COLLEGE ef RHEUMATOLOGY pening cena Pfs Evidence-Based Medicine (EBM) or Key References + Moldofsky H, Harris HW, Archambault WT, Kwong T, Lederman S. Effects of bedtime very low dose cyclobenzaprine on symptoms and sleep physiology in patients with fibromyalgia syndrom double-blind random
Slide 4: Trial TNX-CY-F304 (RELIEF Study)
AMERICAN COLLEGE. of RHEUMATOLOGY Trial TNX-CY-F304 (‘RELIEF’ Study) 9 General Study Design: Phase 3, Randomized, Multicenter (39), Parallel Group, Double- Blind, Placebo-Controlled 14 Week Study Objectives: To evaluate efficacy and safety of bedtime TNX-102 SL in fibromyalgia (FM) Investigational P
Slide 5: Demographics
Demographics Variable ‘Age, years (mean, SD) ‘Sex, female Ethnicity, Hispanic/Latino Race White or Caucasian Black or African American All Other BMI (kg/m?) Education, some college or greater Employed, currently Unable to work due to fibromyalgia Duration of fibromyalgia, years Placebo 55 49.3 (10.2
Slide 6: Primary Efficacy Endpoint Analysis
AMERICAN COLLEGE of RHEUMATOLOGY Primary Efficacy Endpoint Analysis “~~~ Endpoint: change from baseline to Week 14 endpoint in diary NRS weekly average of daily self- reported average pain severity Placebo TNX-102 SL (N= 255) (N= 248) Change Change Visit from from Statistic value Baseline value Base
Slide 7: Responder Rates
Responder Rates Continuous Responder Graph shows a selected percent pain reduction rate (x-axis) for responder status versus percent of responders in each treatment group (y-axis) For a >30% Pain Reduction Responder Analysis: + Choose 230% on x-axis + On y-axis find + TNX-102 SL at 46.8% + Placebo a
Slide 8: Pain Reduction by Daily Diary Across Weeks of Study
AMERICAN COLLEGE Pain Reduction by Daily Diary Across “Rreumarotocy 14 Weeks of Study + Note: in addition ° to statistically 02 significant pain reduction at Week 14, TNX- 102 SL separated from Placebo at Weeks 1, 5, 8, 10, 12, & 13; all p<0.0452 +-Placebo (N=255) “-TNX-102 St (N=248) LS Mean Differ
Slide 9: Key Secondary Efficacy Endpoint Analyses
AMERICAN COLLEGE of RHEUMATOLOGY pring nate Pfc Key Secondary Efficacy Endpoint Analyses + Sequential test procedure to adjust for multiplicity applied to primary and key secondary endpoints; hierarchy of key secondaries: + PGIC, responder analysis, proportion with ‘2’ or ‘1’ at Week 14 + FIQR Sympt
Slide 10: Patient Global Impression of Change
Patient Global Impression of Change + At Week 14, greater proportion of responders to TNX-102 SL, at 37.5% versus Placebo, at 29.4%; however, did not achieve statistical significance Remaining secondary endpoints in hierarchy automatically considered non-significant regardless of the p-value Note: W
Slide 11: FIQR Symptoms Domain
AMERICAN COLLEGE ef RHEUMATOLOGY Bape le Presi FIQR Symptoms Domain + On Fibromyalgia FIQR Symptoms Domain MCFB at Weeks 2,6,10, & 14 Impact Questionnaire ° - Revised Symptoms Domain at Week 14 TNX-102 SL separated from placebo by -4.3 (1.6) units, p=0.007 + Note: Week 2 p=0.020 and Week 10 5 p=0.01
Slide 12: Fibromyalgia Impact Questionnaire Revised: Symptoms & Impact Items
AMERICAN COLLEGE Fibromyalgia Impact RHEUMATOLOGY Questionnaire — Revised: Symptoms |Miigiias "iSwers’ tener intsteane & Impact Items Please rate your. (last 7 days) Level of Pain -2.3 (0.15) 0.014" “1.9 (0.15) _ -0.5 (0.20) + Broad range of FM symptoms and Z both global impact items Level of Eneroy
Slide 13: FIQR Function Domain
FIQR Function Domain FIQR Function Domain MCFB at Weeks 2,6,10, & 14 + On Fibromyalgia Impact Questionnaire - Revised Function Domain at Week 14 TNX-102 SL separated from Placebo by -4.4 (4.7) units, p=0.009 + Note: Week 10 p=0.016 + Slope remains downward after Week 6 for active but not for Placebo
Slide 14: PROMIS Sleep Disturbance Instrument
AMERICAN COLLEGE of RHEUMATOLOGY PROMIS Sleep Disturbance Instrument. + On PROMIS Sleep PROMIS Sleep Disturbance MCFB at Weeks 2,6,10, & 14 Disturbance instrument T-scores at Week 14 TNX-102 SL separated from placebo by -2.9 (0.82) units, p<0.001 + Note: Week 2 p<0.001, Week 6 p=0.001, Week 10 p=0.0
Slide 15: PROMIS Fatigue Instrument
“AMERICAN COLLEGE of RHEUMATOLOGY PROMIS Fatigue Instrument + On PROMIS Fatigue PROMIS Fatigue MCFB at Weeks 2,6,10, & 14 instrument T-scores at ° Week 14 TNX-102 SL Shanon S28 me Nez separated from placebo by -1.8 (0.76) units, p=0.018 + Note: Week 6 .008, Week 10 2 LS MCFB (Se) in PROMIS Fatigue W
Slide 16: Sleep Quality by Daily Diary
“AMERICAN COLLEGE of RHEUMATOLOGY Sleep Quality by Daily Diary Daily Diary Sleep Quality Across All Study Weeks + Sleep Quality by ° weekly averages of fo eae ie) daily diary NRS scores 2-0 7 (n-24e) at Week 14 separated S 06 for TNX-102 SL from $08 placebo by -0.6 (0.17) #4 units, p<0.001 F2 + All
Slide 17: Safety
AMERICAN COLLEGE of RHEUMATOLOGY Safety 7 RemMATOLOSY Exposure Mean (SD) treatment duration (days): TNX-102 SL 88.9 (26.2); Placebo 88.7 (24.9) Mean (SD) study days drug taken: TNX-102 SL 77.1 (25.2); Placebo 75.9 (23.6) Treatment-Emergent Adverse Events (TEAEs) Rated as Severe TNX-102 SL 4.4% of al
Slide 18: Treatment Emergent Adverse Events (TEAEs)
AMERICAN COLLEGE ef RHEUMATOLOGY Treatment Emergent Adverse Events (TEAEs) All TEAEs at a rate of 2 3% in the TNX-102 SL group isco coesecsoemeas [nx 107 st Oral Cavity Adverse Events Hypoaesthesia oral Paraesthesia oral Dysgeusia Glossodynia Dry mouth Systemic Adverse Events Sedation Fatigue 43 (17
Slide 19: Conclusions
AMERICAN COLLEGE of RHEUMATOLOGY Conclusions / RHEUMATOLOGY * TNX-102 SL reduced pain in fibromyalgia significantly more than Placebo (p=0.010) over 14 weeks of treatment + 30% pain responder analysis demonstrated greater responders with TNX- 102 SL at 46.8% than with Placebo at 34.9% (p=0.006) * TN
Slide 20: Acknowledgements
AMERICAN COLLEGE ef RHEUMATOLOGY Acknowledgements /RuymatoLocy Mary Kelley!, Annabelle Iserson1, Perry Peters?, Ashild Peters!, Candace Flint!, Judy Gendreau2, Herb Harris!, Ben Vaughn3, and Seth Lederman? 1Tonix Pharmaceuticals, Inc., New York, NY, 2Gendreau Consulting LLC, Poway, CA 3Rho, Inc, Cha