Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (August 2021)
34 slides from Tonix Pharmaceuticals's investor presentation, Aug 2, 2021
Slide 1: Investor Presentation
© 2021 Tonix Pharmaceuticals Holding Corp. 1 August 2021 Investor Presentation NASDAQ:TNXP Version P0309 8 - 2 - 2021 (Doc 0871)
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: Tonix Pharmaceuticals: Who We Are and What We Do
© 2021 Tonix Pharmaceuticals Holding Corp. 3 Tonix Pharmaceuticals: Who We Are and What We Do Mission And Purpose Clinical - stage biopharmaceutical company that invents, licenses, acquires and develops innovative medicines to help patients manage central nervous system (CNS) and immunology conditio
Slide 4: Tonix Pipeline – CNS Portfolio
© 2021 Tonix Pharmaceuticals Holding Corp. 4 Tonix Pipeline – CNS Portfolio CANDIDATES INDICATION STATUS CNS Portfolio TNX - 102 SL 1 Fibromyalgia (FM) Mid - Phase 3 – ongoing Posttraumatic Stress Disorder (PTSD) Phase 3 ready Agitation in Alzheimer’s Phase 2 ready Alcohol Use Disorder Long COVID (P
Slide 5: Tonix Pipeline – COVID-19 Portfolio
© 2021 Tonix Pharmaceuticals Holding Corp. 5 Tonix Pipeline – COVID - 19 Portfolio CANDIDATES INDICATION STATUS COVID - 19 Portfolio TNX - 1800 COVID - 19 vaccine 1 Phase 1, 1H 2022* TNX - 2300 COVID - 19 vaccine 2 Preclinical TNX - 102 SL Long COVID (PASC 3 ) Clinical – pre - IND 4 TNX - 2100 SARS
Slide 6: Tonix Pipeline – Immunology & Biodefense Portfolios
© 2021 Tonix Pharmaceuticals Holding Corp. 6 Tonix Pipeline – Immunology & Biodefense Portfolios CANDIDATES INDICATION STATUS Immunology /Immuno - oncology (IO) TNX - 1500 1 Organ Transplant Rejection/Autoimmune Conditions Preclinical TNX - 1700 2 Gastric and pancreatic cancers Preclinical 1 anti -
Slide 7: TNX-102 SL FM Lead Program Background on Fibromyalgia
© 2021 Tonix Pharmaceuticals Holding Corp. 7 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 8: Challenges with Current Pharmacotherapy
© 2021 Tonix Pharmaceuticals Holding Corp. 8 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 9: Fibromyalgia Unmet Need and Ideal Treatment Profile
© 2021 Tonix Pharmaceuticals Holding Corp. 9 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 10: TNX-102 SL: Engineered to Treat FM
© 2021 Tonix Pharmaceuticals Holding Corp. 10 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 Pro
Slide 11: Phase 3 F304/RELIEF Study: Design
© 2021 Tonix Pharmaceuticals Holding Corp. 11 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 12: F304/RELIEF Study Topline Primary Efficacy Endpoint
© 2021 Tonix Pharmaceuticals Holding Corp. 12 F304/RELIEF Study Topline Primary Efficacy Endpoint ◊ ◊ Primary Outcome Measure at Week 14 Placebo (N=255) TNX - 102 SL (N=248) Treatment Difference P value LS Mean Change from Baseline 1 (SE) - 1.5 (0.12) - 1.9 (0.12) - 0.4 (0.16) 0.010* Statistical Met
Slide 13: F304/RELIEF Study: Primary Efficacy Endpoint Results (continued)
© 2021 Tonix Pharmaceuticals Holding Corp. 13 F304/RELIEF Study: Primary Efficacy Endpoint Results (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
Slide 14: F304/RELIEF Study: Continuous Responder Analysis Graph
© 2021 Tonix Pharmaceuticals Holding Corp. 14 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
Slide 15: F304/RELIEF Study: Key Secondary Efficacy Endpoints
© 2021 Tonix Pharmaceuticals Holding Corp. 15 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 16: Adverse Events in F304/RELIEF Study
© 2021 Tonix Pharmaceuticals Holding Corp. 16 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 17: TNX-102 SL Intellectual Property
© 2021 Tonix Pharmaceuticals Holding Corp. 17 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, and Pa
Slide 18: TNX-102 SL for FM: Next Steps
© 2021 Tonix Pharmaceuticals Holding Corp. 18 TNX - 102 SL for FM: Next Steps 2 nd Phase 3 study, RALLY (F306) • July 2021: Tonix stopped enrollment in the RALLY study following an unblinded, pre - planned interim analysis by the Independent Data Monitoring Committee (IDMC) • Based on interim analys
Slide 19: TNX-102 SL for Long COVID (PASC)
© 2021 Tonix Pharmaceuticals Holding Corp. 19 TNX - 102 SL for Long COVID (PASC) Long COVID or Post - acute Sequelae of COVID - 19 (PASC) • Symptoms can include fatigue, sleep disorders, pain, fevers, shortness of breath, cognitive impairment described as “brain fo g”, gastrointestinal symptoms, anx
Slide 20: COVID Vaccines with EUA: Still Uncertainty
© 2021 Tonix Pharmaceuticals Holding Corp. 20 COVID - 19 Vaccines with Emergency Use Authorization (EUA): Still Uncertainty Durability of protection • Are vaccinated people protected one year later? • Need for annual vaccinations with mRNA vaccines? Effect on forward transmission (spread of infectio
Slide 21: TNX-1800: a COVID Vaccine Candidate
© 2021 Tonix Pharmaceuticals Holding Corp. 21 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 22: Potential Profile of TNX-1800 Compared to EUA Covid-19 Vaccines
© 2021 Tonix Pharmaceuticals Holding Corp. 22 Potential Profile of TNX - 1800 Compared to EUA Covid - 19 Vaccines Criteria EUA Vaccines TNX - 1800 Number of shots One – two One Duration Unknown Years / decades Boosters Unknown Not required Protection from variants Unknown Likely provides protection
Slide 23: COVID Vaccine Platform: Planned Internal Development and Manufacturing Capabilities
© 2021 Tonix Pharmaceuticals Holding Corp. 23 COVID - 19 Vaccine Platform: Planned Internal Development and Manufacturing Capabilities Infectious Disease R&D Facility (RDF) – Frederick, MD • Function : Accelerated development of vaccines and antiviral drugs against COVID - 19, its variants and other
Slide 24: TNX-3500: SARS-CoV-2 Antiviral for the Treatment of COVID-19
© 2021 Tonix Pharmaceuticals Holding Corp. 24 TNX - 3500 1 : SARS - CoV - 2 Antiviral for the Treatment of COVID - 19 TNX - 3500 (sangivamycin) – potential monotherapy antiviral 2 • Licensed from OyaGen , April 2021 • Demonstrated broad spectrum antiviral (nanomolar activity against SARS - CoV - 2,
Slide 25: TNX-2100: Potential Skin Test to Measure SARS-CoV-2 Exposure and T Cell Immunity
© 2021 Tonix Pharmaceuticals Holding Corp. 25 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 26: TNX-1300: Cocaine Esterase (CocE)
© 2021 Tonix Pharmaceuticals Holding Corp. 26 TNX - 1300: Cocaine Esterase (CocE) CocE is the most potent known catalyst for cocaine degradation • Natural bacterial CocE is unstable at body temperature Thermostable bacterial CocE (active for ~6 hours at body temperature) • Targeted mutations stabili
Slide 27: TNX-1900 (Intranasal Potentiated Oxytocin) for the Treatment of Migraine
© 2021 Tonix Pharmaceuticals Holding Corp. 27 TNX - 1900 (Intranasal Potentiated Oxytocin) for the Treatment of Migraine Intranasal oxytocin(OT) has potential utility in treating migraine 1 • Intranasal ( i.n. ) OT reaches the trigeminal ganglion • Preclinical evidence of OT blocking CGRP release an
Slide 28: TNX-2900 for the Treatment of Prader-Willi Syndrome
© 2021 Tonix Pharmaceuticals Holding Corp. 28 TNX - 2900 ( i.n. Potentiated OT) for the Treatment of Prader - Willi Syndrome Prader - Willi syndrome is the most common genetic cause of life - threatening childhood obesity 1 • Results in lack of suckling in infants and, in children and adults, severe
Slide 29: TNX-601 CR for the Treatment of Major Depressive Disorder
© 2021 Tonix Pharmaceuticals Holding Corp. 29 TNX - 601 CR* (Tianeptine Oxalate and Naloxone HCl Controlled Release) Tablets for the Treatment of Major Depressive Disorder (MDD) Proprietary new controlled release formulation for once - daily dosing • Pending toxicology results, and IND clearance, Ph
Slide 30: TNX-601 CR: A Potential Treatment for Depression
© 2021 Tonix Pharmaceuticals Holding Corp. 30 TNX - 601 CR : A Potential Treatment for Depression TNX - 601 CR’s proposed mechanism of action is completely distinct from any approved antidepressant in the U.S. • Antidepressant activity is believed to relate to indirect modulation of the glutamatergi
Slide 31: TNX-1500, a New CD40L Antibody, for the Prevention of Allograft Rejection
© 2021 Tonix Pharmaceuticals Holding Corp. 31 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 32: Milestones – Recently Completed and Upcoming
© 2021 Tonix Pharmaceuticals Holding Corp. 32 Milestones – Recently Completed and Upcoming 1 □ 4 th Quarter 2020 Positive topline data from TNX - 102 SL Phase 3 F304/RELIEF study in fibromyalgia reported □ 1 st Quarter 2021 Non - human primate positive efficacy data from TNX - 1800 in COVID - 19 mod
Slide 33: Management Team
© 2021 Tonix Pharmaceuticals Holding Corp. 33 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 34: Thank You!
© 2021 Tonix Pharmaceuticals Holding Corp. 34 Thank You!
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