Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — The 5th International Congress on Controversies in Fibromyalgia (March 2023)

16 slides from Tonix Pharmaceuticals's conference presentation, Mar 30, 2023

  1. Slide 1: The 5th International Congress on Controversies in Fibromyalgia

    The 5th International Congress on Controversies in Fibromyalgia NASDAQ: TNXP Version P0427 March 30, 2023 (Doc 1185) © 2023 Tonix Pharmaceuticals Holding Corp.

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

    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 Litigation Reform Act of 1995. These statements may be i

  3. Slide 3: TNX-102 SL Fibromyalgia and Long COVID status

    TNX-102 SL* Fibromyalgia Status: Mid-Phase 3 Cyclobenzaprine (Protectic®) • One positive Phase 3 study (RELIEF) completed Pipeline in a Product • Second Phase 3 study (RALLY) missed primary endpoint • Confirmatory Phase 3 study (RESILIENT) is currently enrolling A unique, sublingual formulation of c

  4. Slide 4: TNX-102 SL: F304 (RELIEF) Phase 3 Study

    TNX-102 SL: F304 (RELIEF) Phase 3 Study CNS PORTFOLIO • 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 Product (IP):

  5. Slide 5: Demographics

    Demographics CNS PORTFOLIO Placebo TNX-102 SL Total Variable N=255 N=248 N=503 Age, years (mean, SD) 49.3 (10.2) 50.0 (9.4) 49.6 (9.8) Sex, female 247 (96.9%) 232 (93.5%) 479 (95.2%) Ethnicity, Hispanic/Latino 42 (16.5%) 43 (17.3%) 85 (16.9%) Race White or Caucasian 216 (84.7%) 222 (89.5%) 438 (87.1

  6. Slide 6: Primary Efficacy Endpoint Analysis

    Primary Efficacy Endpoint Analysis CNS PORTFOLIO Endpoint: change from baseline to Week 14 endpoint in diary NRS weekly average of daily self-reported average pain severity * p <0.0452, adjusted p-value necessary for significance due to alpha-spend from an interim analysis; for Week 14 results, Cui,

  7. Slide 7: Responder Rates

    Responder Rates CNS PORTFOLIO Continuous Responder Graph Continuous Responder Graph shows a selected percent pain reduction rate (x-axis) for RELIEF STUDY Percent of Total Subjects in Treatment Group responder status versus percent of responders in each Placebo TNX-102 SL treatment group (y-axis) Fo

  8. Slide 8: Pain Reduction by Daily Diary Across Weeks of Study

    Pain Reduction by Daily Diary Across 14 Weeks of Study CNS PORTFOLIO 0 • Note: in addition to Placebo (N=255) -0.2 statistically significant LS Mean Difference (SE) in NRS Pain Score * TNX-102 SL (N=248) pain reduction at -0.4 Week 14, TNX-102 -0.6 SL separated from -0.8 Placebo at Weeks 1, -1 5, 8,

  9. Slide 9: Key Secondary Efficacy Endpoint Analyses

    Key Secondary Efficacy Endpoint Analyses CNS PORTFOLIO • 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 Symptoms domain, change from baseline a

  10. Slide 10: Safety

    Safety CNS PORTFOLIO • 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 all TEAEs in group; Place

  11. Slide 11: Treatment Emergent Adverse Events (TEAEs)

    Treatment Emergent Adverse Events (TEAEs) CNS PORTFOLIO • Well tolerated: only systemic TEAE that occurred at a rate of ≥3.0% in either arm was somnolence, sedation, and dry mouth in the TNX-102 SL arm • Consistent with known side effects of marketed oral cyclobenzaprine TNX-102 SL (N=248) Placebo (

  12. Slide 12: Conclusions

    Conclusions CNS PORTFOLIO • 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) • TNX-102 SL had broad syndromal effect

  13. Slide 13: Since the F304 RELIEF Study

    Since the F304 “RELIEF” Study CNS PORTFOLIO • Fibromyalgia ‒ F306 “RALLY”  Second phase 3 study similar to RELIEF  Enrollment was stopped at the interim  Excess drop-outs in both drug- and placebo-arms ⁃ Delta wave of the COVID-19 landscape may have contributed to terminations ‒ F307 “RESILIENT”

  14. Slide 14: Phase 3 RESILIENT Study Design

    Phase 3 RESILIENT Study Design CNS PORTFOLIO General study characteristics: • Randomized, double-blind, placebo-controlled study in fibromyalgia • U.S. sites only, expected to enroll approximately 470 patients • One unblinded interim analysis based on 50% of randomized participants Primary Endpoint:

  15. Slide 15: Phase 2 PREVAIL Fibromyalgia-Type Long COVID Study Design

    Phase 2 PREVAIL Fibromyalgia-Type Long COVID Study Design CNS PORTFOLIO Study characteristics: • Randomized, double-blind, placebo-controlled study of TNX-102 SL in fibromyalgia-type Long COVID • U.S. sites only Primary Endpoint: • Daily diary pain severity score change from baseline to Week 14 (TNX

  16. Slide 16: Thank You

    THANK YOU © 2023 Tonix Pharmaceuticals Holding Corp.

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