Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Corporate Update (December 2020)

16 slides from Tonix Pharmaceuticals's corporate update, Dec 7, 2020

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

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

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

    © 2020 Tonix Pharmaceuticals Holding Corp. 2 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: TNX-102 SL: Potential Treatment for Fibromyalgia

    © 2020 Tonix Pharmaceuticals Holding Corp. 3 Volkswagen Check Engine [Photograph]. (2011, October 14). Wikipedia When the check engine light malfunctions, the light is on even though the car is not malfunctioning • Fibromyalgia is considered a central nervous system disorder with symptoms that inclu

  4. Slide 4: Overview of TNX-102 SL

    © 2020 Tonix Pharmaceuticals Holding Corp. 4 Overview of TNX - 102 SL* 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

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

    © 2020 Tonix Pharmaceuticals Holding Corp. 5 TNX - 102 SL: Differentiation from Oral Formulations FEATURE BENEFIT ADVANTAGE Cyclobenzaprine 40+ years as oral medication Established safety record Formulation: Protectic ® Allows submucosal absorption Not achievable with oral formulation Administration

  6. Slide 6: Study Design: Phase 3 RELIEF

    © 2020 Tonix Pharmaceuticals Holding Corp. 6 Study Design: Phase 3 RELIEF Primary e ndpoint (Week 14) : • Daily diary pain severity score change (TNX - 102 SL 5.6 mg vs. placebo) from baseline in the weekly average as measured by the numerical rating scale (NRS), using mixed model repeated measures

  7. Slide 7: RELIEF Study: Primary Efficacy Endpoint

    © 2020 Tonix Pharmaceuticals Holding Corp. 7 RELIEF Study: Primary Efficacy Endpoint 1 ◊ ◊ 2 TNX - 102 SL is in clinical stage of development and not approved for any indication Primary Outcome Measure at Week 14 Placebo (N=255) TNX - 102 SL 2 (N=248) Treatment Difference P value LS Mean Change from

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

    © 2020 Tonix Pharmaceuticals Holding Corp. 8 RELIEF Study: Primary Efficacy Endpoint (continued) -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 Change from Baseline (SE) in NRS Pain Score Study Week RELIEF Study Mean Change from Baseline in Weekly Ave

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

    © 2020 Tonix Pharmaceuticals Holding Corp. 9 RELIEF Study: Key Secondary Efficacy Endpoints ◊ ◊ *TNX - 102 SL is in clinical stage of development and not approved for any indication Outcome Measure at Week 14 Intent - to - Treat Analysis 1 P - value Non - Specific Patient Global Impression of Change

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

    © 2020 Tonix Pharmaceuticals Holding Corp. 10 P e r c e n t o f S u b j e c t s 0 10 20 30 40 50 60 70 80 90 100 Percentage Redution in Pain >=0% >=10% >=20% >=30% >=40% >=50% >=60% >=70% >=80% >=90% =100% Placebo TNX-102 SL Proportion of Subjects in Arm Cut - Off Points for Percentage Pain Responde

  11. Slide 11: Adverse Events in RELIEF Study

    © 2020 Tonix Pharmaceuticals Holding Corp. 11 Adverse Events* (AEs) in RELIEF Study 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

  12. Slide 12: Safety and Tolerability in RELIEF Study

    © 2020 Tonix Pharmaceuticals Holding Corp. 12 Safety and Tolerability in RELIEF Study • 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 S

  13. Slide 13: Intellectual Property – U.S. Protection expected until 2035

    © 2020 Tonix Pharmaceuticals Holding Corp. 13 TNX - 102 SL Intellectual Property – U.S. Protection expected until 2035 • 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

  14. Slide 14: Next Steps

    © 2020 Tonix Pharmaceuticals Holding Corp. 14 Next Steps © 2020 Tonix Pharmaceuticals Holding Corp . • Results from ongoing 2 nd potential pivotal Phase 3 study, RALLY (F306), for TNX - 102 SL in fibromyalgia expected in 2 nd half of 2021 • Same protocol design as RELIEF study • Enrollment began in

  15. Slide 15: Conclusion

    © 2020 Tonix Pharmaceuticals Holding Corp. 15 Conclusion © 2020 Tonix Pharmaceuticals Holding Corp . • 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

  16. Slide 16: Q&A

    © 2020 Tonix Pharmaceuticals Holding Corp. 16 Q&A

Tonix Pharmaceuticals Holding — Corporate Update (December 2020) on 6ix