Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Corporate Update (December 2020)

16 slides from Tonix Pharmaceuticals's corporate update, December 2020

  1. Slide 1: Results of Phase 3 RELIEF Study in Fibromyalgia

    1 Results of Phase 3 RELIEF Study in Fibromyalgia Version P0260 12-7-2020 (Doc 0742) © 2020 Tonix Pharmaceuticals Holding Corp.

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

    Cautionary Note on Forward-Looking Statements 2 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

  3. Slide 3: TNX-102 SL: Potential Treatment for Fibromyalgia

    TNX-102 SL: Potential Treatment for Fibromyalgia 3 • Fibromyalgia is considered a central nervous system disorder with symptoms that include: chronic widespread pain, nonrestorative sleep, fatigue, diminished cognition and mood disturbances When the check engine light malfunctions, the • Believed to

  4. Slide 4: Overview of TNX-102 SL

    Overview of TNX-102 SL* 4 Protectic® proprietary formulation of cyclobenzaprine that supports sublingual administration TNX-102 SL is a non-opioid, centrally-acting analgesic that works by improving sleep quality ◊ Scientific Rationale for Protectic® Formulation ◊ • Engenders unique pharmacokinetic

  5. Slide 5: TNX-102 SL: Differentiation from Oral Formulations

    TNX-102 SL: Differentiation from Oral Formulations 5 FEATURE BENEFIT ADVANTAGE Cyclobenzaprine 40+ years as oral medication Established safety record Formulation: Allows submucosal absorption Not achievable with oral formulation Protectic® Administration: Avoids first-pass metabolism; reduced Bypass

  6. Slide 6: Study Design: Phase 3 RELIEF

    Study Design: Phase 3 RELIEF 6 General study characteristics: Primary endpoint (Week 14): • Randomized, double-blind, placebo-controlled • Daily diary pain severity score change (TNX-102 SL 5.6 study in fibromyalgia in 39 U.S. sites (full mg vs. placebo) from baseline in the weekly average as sample

  7. Slide 7: RELIEF Study: Primary Efficacy Endpoint

    RELIEF Study: Primary Efficacy Endpoint1 7 Primary Outcome Measure Placebo TNX-102 SL2 at Week 14 (N=255) (N=248) Treatment Difference P value LS Mean Change LS Mean Change Difference in LS Mean Change from Baseline from Baseline from Baseline Between TNX-102 ◊ (SE) (SE) SL and Placebo (SE) ◊ Daily

  8. Slide 8: RELIEF Study: Primary Efficacy Endpoint (continued)

    RELIEF Study: Primary Efficacy Endpoint (continued) 8 RELIEF Study Mean Change from Baseline in Weekly Averages of Daily NRS Pain Scores LS Mean Change from Baseline (SE) in NRS Pain Score 0 Placebo (N=255) TNX-102 SL (N=248) -0.2 -0.4 -0.6 -0.8 * -1 -1.2 -1.4 -1.6 -1.8 * * -2 * * * * -2.2 0 1 2 3 4

  9. Slide 9: RELIEF Study: Key Secondary Efficacy Endpoints

    RELIEF Study: Key Secondary Efficacy Endpoints 9 Outcome Measure at Week 14 Intent-to-Treat Analysis1 P-value Non-Specific Responder Analysis: Patient Global Impression of Change Proportion “Much Improved” or “Very Much Improved” 0.058 ◊ ◊ Fibromyalgia Syndrome-Related FIQ-R Symptom Domain Mean Chan

  10. Slide 10: RELIEF Study: Continuous Responder Analysis (CRA) Graph

    RELIEF Study: Continuous Responder Analysis (CRA) Graph 10 • The CRA graph allows one to see the proportion of 100 responders over an entire Placebo TNX-102 SL in Arm range of cut-off points TNX-102 SL 5.6 mg 90 • For example, >=30% 80 Placebo improvement in pain is considered clinically Subjects 70

  11. Slide 11: Adverse Events (AEs) in RELIEF Study

    Adverse Events* (AEs) in RELIEF Study 11 TNX-102 SL (N=248) Placebo (N=255) Total (N=503) Administration Site Reactions N % N % N % Tongue/mouth numbness 43 17.3 2 0.8 45 8.9 Tongue/mouth pain/discomfort 29 11.7 5 2.0 34 6.8 Taste impairment 16 6.5 1 0.4 17 3.4 Tongue/mouth tingling 14 5.6 1 0.4 15

  12. Slide 12: Safety and Tolerability in RELIEF Study

    Safety and Tolerability in RELIEF Study 12 • No new safety signals in RELIEF at TNX-102 SL 5.6 mg dose • 82.3% in active arm and 83.5% in placebo arm completed the study • 8.9% in active arm and 3.9% in placebo arm discontinued due to adverse events • 7 SAEs in study: 2 in active arm and 5 in placeb

  13. Slide 13: TNX-102 SL Intellectual Property – U.S. Protection expected until 2035

    TNX-102 SL Intellectual Property – U.S. Protection expected until 2035 13 • United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No.

  14. Slide 14: Next Steps

    Next Steps 14 • Results from ongoing 2nd potential pivotal Phase 3 study, RALLY (F306), for TNX-102 SL in fibromyalgia expected in 2nd half of 2021 • Same protocol design as RELIEF study • Enrollment began in September 2020 • Following positive results from RALLY, an NDA could potentially be filed i

  15. Slide 15: Conclusion

    Conclusion 15 • TNX-102 SL is now mid-Phase 3 in fibromyalgia • Millions suffer from this chronic condition • Remains an unmet need due to lack of efficacy and intolerable side effects associated with approved drugs, for many patients • TNX-102 SL is a differentiated compound with robust IP • TNX-10

  16. Slide 16: Q&A

    16 Q&A © 2020 Tonix Pharmaceuticals Holding Corp.

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