Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (August 2020)

20 slides from Tonix Pharmaceuticals's investor presentation, Aug 17, 2020

  1. Slide 1: Investor Presentation

    © 2020 Tonix Pharmaceuticals Holding Corp. 1 August 2020 Version P0241 (Doc 0692) Investor Presentation NASDAQ:TNXP 1

  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: Tonix Financial Overview

    © 2020 Tonix Pharmaceuticals Holding Corp. 3 Tonix Financial Overview NASDAQ: TNXP Cash and cash equivalents, June 30, 2020 $55.0 million Net proceeds from common stock offering - July 15, 2020 $9.6 million Warrant exercises subsequent to June 30, 2020 $2.4 million Average Daily Volume (3 - month av

  4. Slide 4: Tonix Pharmaceuticals: Lead Programs

    © 2020 Tonix Pharmaceuticals Holding Corp. 4 Tonix Pharmaceuticals: Lead Programs 1 © 2020 Tonix Pharmaceuticals Holding Corp. • TNX - 102 SL for fibromyalgia (FM) • Phase 3 clinical development – RELIEF study enrolling • Sublingual cyclobenzaprine tablets at higher dose of 5.6 mg • Milestones: • Se

  5. Slide 5: Our Pipeline – CNS Portfolio

    © 2020 Tonix Pharmaceuticals Holding Corp. 5 Our Pipeline – CNS Portfolio 1 TNX - 102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication. 2 Pre - Investigational New Drug (IND) meeting completed in October 2019 with FDA. Upon recei

  6. Slide 6: Our Pipeline – Immunology Portfolio

    © 2020 Tonix Pharmaceuticals Holding Corp. 6 Our Pipeline – Immunology Portfolio CANDIDATES INDICATION STATUS Immunology Portfolio TNX - 1800 Covid - 19 vaccine – Prioritized Program Preclinical TNX - 801 Smallpox and monkeypox preventing vaccine Preclinical TNX - 1200 Smallpox and monkeypox prevent

  7. Slide 7: Fibromyalgia Landscape

    © 2020 Tonix Pharmaceuticals Holding Corp. 7 Fibromyalgia Landscape • Neurobiological disorder characterized by chronic widespread pain, non - restorative sleep, fatigue, diminished cognition 1 • Recognized as a bona fide condition relatively recently (1980s) • Affects ~6 - 12 million adults (>90% w

  8. Slide 8: Fibromyalgia Program Goals

    © 2020 Tonix Pharmaceuticals Holding Corp. 8 Fibromyalgia Program Goals • TNX - 102 SL is a non - opioid, centrally acting analgesic • Potential to provide a new therapeutic option for the management of fibromyalgia • Treatment objective: restore functionality and quality of life • Potential to broa

  9. Slide 9: TNX-102 SL 2.8 mg: Treatment Activity in Completed FM Trials

    © 2020 Tonix Pharmaceuticals Holding Corp. 9 Phase 3 F301 (AFFIRM) Dose: 2.8 mg Phase 2b F202 (BESTFIT) Dose: 2.8 mg Primary Endpoint: Pain Relief at Week 12 Change in Mean Pain 30% Responder Analysis Key Secondary Endpoints: Global improvement or improvement in symptoms and function Patient Global

  10. Slide 10: Where Are We on the Dose-Response Curve?

    © 2020 Tonix Pharmaceuticals Holding Corp. 10 Where Are We on the Dose - Response Curve? • Dose can make the difference in the consistency and strength of the response • Tonix believes the dose used in the Phase 2b and first Phase 3 studies was potentially too low leading to inconsistent responses R

  11. Slide 11: TNX-102 SL: On-going Phase 3 Study in FM (F304/RELIEF)

    © 2020 Tonix Pharmaceuticals Holding Corp. 11 TNX - 102 SL: On - going Phase 3 Study in FM (F304/RELIEF ) © 2020 Tonix Pharmaceuticals Holding Corp. • Key changes to protocol from previous Phase 3 trial in FM • Exclusive use of higher dose of 5.6 mg (2 x 2.8 mg) • Primary endpoint: mean pain improve

  12. Slide 12: Fibromyalgia Next Steps

    © 2020 Tonix Pharmaceuticals Holding Corp. 12 Fibromyalgia Next Steps • Upcoming milestones (before year end) • Phase 3 interim analysis results expected September 2020 • Topline Phase 3 results expected 4Q20 • TNX - 102 SL is a new, differentiated product candidate • Sleep quality mechanism of acti

  13. Slide 13: Opportunities to Expand to Other Indications

    © 2020 Tonix Pharmaceuticals Holding Corp. 13 Opportunities to Expand to Other Indications Psychiatric Disorders • Stress Disorders (PTSD) • Mood Disorders (Depression) • Anxiety Disorders • Addiction (Alcohol Use Disorder) Chronic Pain States • Chronic wide - spread pain (fibromyalgia) • Osteoarthr

  14. Slide 14: COVID-Vaccine Landscape

    © 2020 Tonix Pharmaceuticals Holding Corp. 14 COVID - 19 Vaccine Landscape • We expect more than one vaccine will be approved by FDA • Different vaccines for different individuals • More than 125 vaccines in development • Diversity of approaches is important since protective immunity is not yet unde

  15. Slide 15: Where Do We Go From Here?

    © 2020 Tonix Pharmaceuticals Holding Corp. 15 Where Do We Go From Here? • Goal: Effective COVID - 19 vaccines • So we can return to work and school • Need #1 Quickly available vaccines • Even if they offer only temporary immunity -- several now in human trials • Need #2 Vaccines providing long - ter

  16. Slide 16: Live, Replicating Virus Vaccines for Other Infectious Diseases

    © 2020 Tonix Pharmaceuticals Holding Corp. 16 Live, Replicating Virus Vaccines for Other Infectious Diseases 1 • Long term, durable immunity • Stimulate T cells and provide years to decades of protection • Single administration, scalable manufacturing • Low dose is amplified by replication, mRNA and

  17. Slide 17: TNX 1800: COVID-Vaccine Engineered for Long-term Immunity

    © 2020 Tonix Pharmaceuticals Holding Corp. 17 TNX 1800: COVID - 19 Vaccine Engineered for Long - term Immunity • Based on viral vaccine developed more than 200 years ago by Edward Jenner for a smallpox vaccine • Eradicated smallpox • T cell eliciting immunity • Single dose immunity without adjuvants

  18. Slide 18: TNX-1800: Development Status for COVID-Vaccine

    © 2020 Tonix Pharmaceuticals Holding Corp. 18 TNX - 1800: Development Status for COVID - 19 Vaccine • Development collaboration with Southern Research • Study of human immunity in convalescent volunteers • Animal testing • Manufacturing agreement with FUJIFILM Diosynth • Development for Good Manufac

  19. Slide 19: Expected Near-Term Milestones

    © 2020 Tonix Pharmaceuticals Holding Corp. 19 Expected Near - Term Milestones □ 3Q20 TNX - 102 SL Phase 3 interim analysis in fibromyalgia □ 4Q20 TNX - 1800 small animal data in COVID - 19 model □ 4Q20 TNX - 1800 primate data in COVID - 19 model □ 4Q20 TNX - 102 SL Phase 3 top - line data in fibromy

  20. Slide 20: Thank You!

    © 2020 Tonix Pharmaceuticals Holding Corp. 20 Thank You!

Tonix Pharmaceuticals Holding — Investor Presentation (August 2020) on 6ix