Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (March 2021)
24 slides from Tonix Pharmaceuticals's investor presentation, Mar 3, 2021
Slide 1: March 2021 Investor Presentation
© 2021 Tonix Pharmaceuticals Holding Corp. 1 March 2021 Investor Presentation NASDAQ:TNXP Version P0277 3 - 3 - 2021 (Doc 0790)
Slide 2: Cautionary Note on Forward-Looking Statements
© 2021 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
Slide 3: Who We Are – Mission and Purpose
© 2021 Tonix Pharmaceuticals Holding Corp. 3 Tonix Pharmaceuticals Who We Are – Mission And Purpose Clinical - stage biopharmaceutical company that invents and develops medicines to help patients manage the central nervous system (CNS) and immunology diseases. “Advancing science to improve patient c
Slide 4: Our Pipeline – CNS Portfolio
© 2021 Tonix Pharmaceuticals Holding Corp. 4 Our Pipeline – CNS Portfolio CANDIDATES INDICATION STATUS CNS Portfolio TNX - 102 SL 1 Fibromyalgia (FM) - Lead Program Mid - Phase 3 – ongoing PTSD - Related Sleep Disturbance 2 Phase 3 ready Agitation in Alzheimer’s Phase 2 ready Alcohol Use Disorder Ph
Slide 5: Our Pipeline – Immunology & Biodefense Portfolio
© 2021 Tonix Pharmaceuticals Holding Corp. 5 Our Pipeline – Immunology & Biodefense Portfolio CANDIDATES INDICATION STATUS Immunology Portfolio TNX - 1800 Covid - 19 vaccine – Prioritized Program 1 Preclinical TNX - 2100 SARS - CoV - 2 skin test for T cell immunity 2 Pre - IND TNX - 2300 Covid - 19
Slide 6: TNX-102 SL FM Lead Program Background on Fibromyalgia
© 2021 Tonix Pharmaceuticals Holding Corp. 6 TNX - 102 SL FM Lead Program Background on Fibromyalgia Fibromyalgia (FM): A chronic condition Core symptoms: • widespread pain • sleep disturbance • fatigue • cognitive symptoms. Significant disabilities (impaired daily function). Course of disease can l
Slide 7: Challenges with Current Pharmacotherapy
© 2021 Tonix Pharmaceuticals Holding Corp. 7 Challenges with Current Pharmacotherapy Limitations of Current Therapies Fewer than half of those treated for fibromyalgia receive relief from the three FDA - approved drugs 1 • Lack of overall response leading to discontinuation or augmentation • Lack of
Slide 8: Fibromyalgia Unmet Need and Ideal Treatment Profile
© 2021 Tonix Pharmaceuticals Holding Corp. 8 Fibromyalgia Unmet Need and Ideal Treatment Profile Unmet Medical Need: Current treatment patterns indicate that new, more effective, and better - tolerated treatments are necessary for management of FM 1 Source: 1. Yang, et al, 2016 Ideal Treatment Profi
Slide 9: TNX-102 SL: Engineered to Treat FM
© 2021 Tonix Pharmaceuticals Holding Corp. 9 TNX - 102 SL: Engineered to Treat FM This unique formulation of cyclobenzaprine has been designed to optimize delivery and absorption, while minimizing the potential residual effects of oral formulations of cyclobenzaprine. Innovative and proprietary Prot
Slide 10: Phase 3 F304/RELIEF Study: Design
© 2021 Tonix Pharmaceuticals Holding Corp. 10 Phase 3 F304/RELIEF Study: Design Primary e ndpoint (Week 14) : • Daily diary pain severity score change from baseline Key Secondary e ndpoint s (Week 14): Symptom Relief • PROMIS Sleep Disturbance instrument T - score • PROMIS Fatigue instrument T - sco
Slide 11: F304/RELIEF Study Topline Primary Efficacy Endpoint
© 2021 Tonix Pharmaceuticals Holding Corp. 11 F304/RELIEF Study Topline Primary Efficacy Endpoint ◊ ◊ 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
Slide 12: Pain Relief Responder Analysis
© 2021 Tonix Pharmaceuticals Holding Corp. 12 Pain Relief Responder Analysis 34.9% 46.8% Placebo TNX-102 SL 1. Arnold et al., 2005 2. Russell et al., 2008 3. Mease et al., 2008 4. Arnold et al., 2008 A ≥ 30% reduction in pain is considered clinically meaningful in pain studies Primary efficacy analy
Slide 13: F304/RELIEF Study: Key Secondary Efficacy Endpoints
© 2021 Tonix Pharmaceuticals Holding Corp. 13 F304/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
Slide 14: Adverse Events in F304/RELIEF Study
© 2021 Tonix Pharmaceuticals Holding Corp. 14 Adverse Events*(AEs) in F304/RELIEF Study Discontinuation rate due to adverse events: 8.9% TNX - 102 SL compared to 3.9% for placebo No serious and unexpected AEs in RELIEF related to TNX - 102 SL • Systemic AEs comparable with prior studies • Oral AEs s
Slide 15: TNX-102 SL for FM: Next Steps
© 2021 Tonix Pharmaceuticals Holding Corp. 15 TNX - 102 SL for FM: Next Steps 2 nd Phase 3 study, RALLY (F306) • Same protocol design as RELIEF study but with 200 more patients 1 • Enrollment began in September 2020 • Interim analysis results expected in 3 rd quarter 2021 2 • Topline results expecte
Slide 16: COVID Vaccines: Still Uncertainty
© 2021 Tonix Pharmaceuticals Holding Corp. 16 COVID - 19 Vaccines: Still Uncertainty Durability of protection • Are vaccinated people protected one year later? • Durable protection is associated with T cell response Protection against forward transmission • Highly contagious nature of CoV - 2 is a m
Slide 17: TNX-1800: a COVID Vaccine Candidate
© 2021 Tonix Pharmaceuticals Holding Corp. 17 TNX - 1800 1 : a COVID - 19 Vaccine Candidate • Utilizes Tonix’s proprietary horsepox virus as a vector • Encodes a protein from SARS - CoV - 2, the cause of COVID - 19 • Developed in collaboration with University of Alberta, Canada • Animal testing with
Slide 18: TNX-2100: Potential Skin Test to Measure SARS-CoV-2 Exposure
© 2021 Tonix Pharmaceuticals Holding Corp. 18 TNX - 2100 1 : Potential Skin Test to Measure SARS - CoV - 2 Exposure and T Cell Immunity TNX - 2100 (SARS - CoV - 2 epitope peptide mixtures for intradermal administration) • Designed to elicit delayed - type hypersensitivity (DTH) in individuals who ha
Slide 19: TNX-1900: Intranasal Potentiated Oxytocin
© 2021 Tonix Pharmaceuticals Holding Corp. 19 TNX - 1900: Intranasal Potentiated Oxytocin Intranasal oxytocin(OT) has potential utility in treating migraine 1 • Preclinical evidence of OT blocking CGRP release and suppressing pain transmission • CGRP antagonists and antibodies approved for the treat
Slide 20: TNX-1300: Cocaine Esterase (CocE)
© 2021 Tonix Pharmaceuticals Holding Corp. 20 TNX - 1300: Cocaine Esterase (CocE) CocE is the most potent known catalyst for cocaine degradation • Natural bacterial CocE is unstable at body temperature Targeted mutations in the bacterial CocE gene (by Columbia and U. of Michigan) resulted in a therm
Slide 21: TNX-1500, a New CD40L Antibody, for Prevention of Allograft Rejection
© 2021 Tonix Pharmaceuticals Holding Corp. 21 TNX 1500, a New CD40 Ligand (CD40L) Antibody, for the Prevention of Allograft Rejection The CD40 - CD40L pathway is a pivotal immune system modulator and is a well - established and very promising treatment target to more safely prevent allograft rejecti
Slide 22: Milestones – Recently Completed and Upcoming
© 2021 Tonix Pharmaceuticals Holding Corp. 22 Milestones – Recently Completed and Upcoming 1 □ 4 th Quarter 2020 Non - human primate immune response positive results reported □ 4 th Quarter 2020 Positive topline data from TNX - 102 SL Phase 3 F304/RELIEF study in fibromyalgia reported □ 1 st Quarter
Slide 23: Management Team
© 2021 Tonix Pharmaceuticals Holding Corp. 23 Management Team Seth Lederman, MD President & CEO Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger , CPA Chief Financial Officer
Slide 24: Thank You!
© 2021 Tonix Pharmaceuticals Holding Corp. 24 Thank You!
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