Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (August 2021)
78 slides from Tonix Pharmaceuticals's investor presentation, Aug 24, 2021
Slide 1: Investor Presentation
© 2021 Tonix Pharmaceuticals Holding Corp. 1 August 2021 Version P0312 8 - 24 - 2021 (Doc 0877) Investor Presentation NASDAQ:TNXP
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, Immunology and Biodefense Portfolio
© 2021 Tonix Pharmaceuticals Holding Corp. 4 Tonix Pipeline – CNS, Immunology and Biodefense Portfolio CANDIDATES INDICATION STATUS Central Nervous System (CNS) TNX - 102 SL 1 Fibromyalgia (FM) Posttraumatic Stress Disorder (PTSD) Long COVID (PASC 2 ) Mid - Phase 3 – ongoing Phase 3 ready Clinical –
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: TNX-1800
© 2021 Tonix Pharmaceuticals Holding Corp. 6 1 TNX - 1800 is an investigational new biologic and has not been approved for any indication. TNX - 1800 1 • Drug Product : modified recombinant horsepox live virus vaccine produced in cell culture for percutaneous administration • Targeted Indication : C
Slide 7: COVID Vaccines with FDA Approval or EUA: Still Uncertainty
© 2021 Tonix Pharmaceuticals Holding Corp. 7 COVID - 19 Vaccines with FDA Approval or Emergency Use Authorization (EUA): Still Uncertainty Durability of protection • Vaccinated people lose protection, starting at 6 months 1 • Increasing rates of “breakthrough” COVID • White House advocating booster
Slide 8: COVID Vaccines: Where do we go from here?
© 2021 Tonix Pharmaceuticals Holding Corp. 8 COVID - 19 Vaccines: Where do we go from here? mRNA vaccines have given us some time, but are unlikely to be a long - term solution • Vaccinated people lost protection, increasing rates of “breakthrough” COVID • COVID is becoming endemic; vaccination of e
Slide 9: TNX-1800: a Live Virus COVID Vaccine Candidate
© 2021 Tonix Pharmaceuticals Holding Corp. 9 TNX - 1800 1 : a Live Virus 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 te
Slide 10: Potential Profile of TNX-1800 Compared to mRNA COVID-19 Vaccines
© 2021 Tonix Pharmaceuticals Holding Corp. 10 Potential Profile of TNX - 1800 Compared to mRNA COVID - 19 Vaccines Criteria mRNA Vaccines TNX - 1800 Number of shots Two One Duration 8 months Years / decades Boosters Recommended Not required Protection from variants Variable Expected Forward Transmis
Slide 11: Warp-Speed COVID Vaccines: Live Virus Vaccines Take Longer to Develop
© 2021 Tonix Pharmaceuticals Holding Corp. 11 Warp - Speed COVID - 19 Vaccines: Live Virus Vaccines Take Longer to Develop • mRNA • Moderna (mRNA - 1273, LNP 1 - encapsulated CoV - 2 Spike [“Spike”] mRNA) EUA 2 • Pfizer & BioNTech ( LNP - encapsulated Spike mRNA ) FDA Approval • Subunit • Sanofi/GSK
Slide 12: COVID Vaccine Landscape
© 2021 Tonix Pharmaceuticals Holding Corp. 12 COVID - 19 Vaccine Landscape • We expect more than one vaccine will be approved by FDA • Different vaccines for different individuals • More than 150 vaccines in development • Diversity of approaches is important since protective immunity is not yet unde
Slide 13: Live, Attenuated Virus Vaccines for Other Infectious Diseases
© 2021 Tonix Pharmaceuticals Holding Corp. 13 Live, Attenuated Virus Vaccines for Other Infectious Diseases 1 • Long term, durable immunity • Expected to stimulate T cells and provide years to decades of protection • Single administration, scalable manufacturing • Low dose is amplified by replicatio
Slide 14: TNX-1800: Engineered for Long-term Immunity
© 2021 Tonix Pharmaceuticals Holding Corp. 14 TNX - 1800 1 : Engineered for Long - term Immunity Based on “vaccinia” vaccine developed more than 200 years ago by Dr. Edward Jenner to prevent smallpox • TNX - 1800 has 99.7% colinear identity with circa 1860 smallpox vaccine 2 • Eradicated smallpox (o
Slide 15: TNX-1800 Vaccination of Non-Human Primates Elicited Neutralizing Antibodies
© 2021 Tonix Pharmaceuticals Holding Corp. 15 TNX - 1800 Vaccination of Non - Human Primates Elicited Anti - SARS - CoV - 2 Neutralizing Antibodies and Skin Reaction or “Take” in All Eight Animals STUDY DESIGN : Compares TNX - 1800 to TNX - 801 (horsepox virus, no CoV - 2 protein) at two doses in
Slide 16: TNX-1800 Vaccination and SARS-CoV-2 Challenge of Non-Human Primates
© 2021 Tonix Pharmaceuticals Holding Corp. 16 TNX - 1800 Vaccination and SARS - CoV - 2 Challenge of Non - Human Primates Findings and Conclusions CHALLENGE WITH SARS - COV - 2: Six days after challenge with SARS - CoV - 2, TNX - 1800 vaccinated animals had undetectable 1 SARS - CoV - 2 in upper o
Slide 17: Why Use a Horsepox Platform for a Vaccine?
© 2021 Tonix Pharmaceuticals Holding Corp. 17 Why Use a Horsepox Platform for a Vaccine? Horsepox can be engineered to express foreign genes • Lack of persistence or genomic integration in the host • Strong immunogenicity as a vaccine • Readily manufacture at scale • Live, attenuated vaccine – direc
Slide 18: TNX-1800 is Based on a Horsepox Virus Vector
© 2021 Tonix Pharmaceuticals Holding Corp. 18 TNX - 1800 is Based on a Horsepox Virus (HPXV) Vector Designed to Express SARS - CoV - 2 S Protein *TNX - 1800 is at the pre - IND stage of development Horsepox sHPXV ~200,000 Bp TNX - 1800 * rHPXV/SARS - CoV - 2S ~200,000 Bp Homologous Recombination
Slide 19: Vaccinia Induces a Skin Reaction Called "Take"
© 2021 Tonix Pharmaceuticals Holding Corp. 19 Vaccinia Induces a Skin Reaction Called “Take” – Described by Dr. Edward Jenner 1. Fulginiti VA, et al. Clin Infect Dis. 2003;37(2):241 - 250. 2. Liu L, et al. Nature Med. 2010;16(2):224 - 228. 3. Centers for Disease Control and Prevention. Accessed Apri
Slide 20: Unique Challenges of SARS-CoV-2
© 2021 Tonix Pharmaceuticals Holding Corp. 20 Unique Challenges of SARS - CoV - 2 SARS Rate of death 1,2 Deaths 2 Rate of infectivity 1 Incubation time 2 Asymptomatic 3 0.4 2 - 7 days ~13% ~10% SARS - CoV - 2 Rate of death 1,4 Deaths (as of July 2021) 5 Rate of infectivity 1,4 Incubation time 2,4 As
Slide 21: Infection of Type II Pneumocytes Can Lead to Lethal Respiratory Illness
© 2021 Tonix Pharmaceuticals Holding Corp. 21 Infection of Type II Pneumocytes Can Lead to Lethal Respiratory Illness Capillary Type II pneumocytes Inhalation Exhalation Type II pneumocytes in the alveoli secrete pulmonary surfactants that are necessary for effective gas exchange. 2 SARS - CoV - 2 I
Slide 22: SARS-CoV-2 Hijacks the Respiratory System to Spread Contagious Virus
© 2021 Tonix Pharmaceuticals Holding Corp. 22 SARS - CoV - 2 Hijacks the Respiratory System to Spread Contagious Virus Respiratory epithelium Capillary Airway Resting CD8 T cell Endothelial cell Exhalation spreads virus • Virus factories release virions by continuous budding • Breathing, speaking or
Slide 23: CoV-Specific T Cells Kill the Virus Factories
© 2021 Tonix Pharmaceuticals Holding Corp. 23 CoV - 2 Specific T Cells Kill the Virus Factories • Natural immunity or vaccine protection has the potential to decrease forward transmission • T cells specifically kill virally infected cells Bar - On YM, et al. eLife . 2020;9:e57309 . Respiratory epith
Slide 24: Contrasting T cell and Antibody Immunity
© 2021 Tonix Pharmaceuticals Holding Corp. 24 Contrasting T cell and Antibody Immunity • T cell immunity • Durable or long - lived (many years) • Recognize fragments of pathogens on the surfaces of infected cells • Cannot recognize pathogens directly • Potential to clear viral infections (by killing
Slide 25: TNX-1800: Potential Development and Uses
© 2021 Tonix Pharmaceuticals Holding Corp. 25 TNX - 1800: Potential Development and Uses • Potential to protect against CoV - 2 Variants • T cell epitopes are short stretches of peptides (~8 - 14 aa fragments) that so far seem to be conserved between variants • Clinical trials will test potential pr
Slide 26: COVID Vaccine Platform: Planned Internal Development and Manufacturing Capabilities
© 2021 Tonix Pharmaceuticals Holding Corp. 26 COVID - 19 Vaccine Platform: Planned Internal Development and Manufacturing Capabilities Infectious Disease R&D Center (RDC) – Frederick, MD • Function : Accelerated development of vaccines and antiviral drugs against COVID - 19, its variants and other i
Slide 27: Infectious Disease R&D Facility
© 2021 Tonix Pharmaceuticals Holding Corp. 27 Infectious Disease R&D Facility Expect to close on acquisition from Southern Research October 1, 2021 Located in Frederick, MD
Slide 28: Advanced Development Center Renderings
© 2021 Tonix Pharmaceuticals Holding Corp. 28 Advanced Development Center Renderings • Groundbreaking August 2021 • Expect to be operational 1H22 • Located in New Bedford, MA
Slide 29: TNX-3500
© 2021 Tonix Pharmaceuticals Holding Corp. 29 1 TNX - 3500 is an investigational new drug and has not been approved for any indication. TNX - 3500 1 • Drug Product : sangivamycin • Targeted Indication : COVID - 19 antiviral
Slide 30: Anti-COVID Therapeutics
© 2021 Tonix Pharmaceuticals Holding Corp. 30 Anti - COVID - 19 Therapeutics The only antiviral that is FDA approved is Remdesivir/ Veklury ® from Gilead • Intravenous ( i.v. ) medicine • Approved for patients who are at least 12 years old and require hospitalization • May shorten the time to recove
Slide 31: TNX-3500: SARS-CoV-2 Antiviral for the Treatment of COVID-19
© 2021 Tonix Pharmaceuticals Holding Corp. 31 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 activity (nanomolar activity against SARS -
Slide 32: TNX-2300
© 2021 Tonix Pharmaceuticals Holding Corp. 32 1 TNX - 2300 is an investigational new biologic and has not been approved for any indication. TNX - 2300 1 • Drug Product : modified parainfluenza virus live virus vaccine for percutaneous administration produced in cell culture • Targeted Indication : C
Slide 33: TNX-2300 and SARS-CoV-2 Vaccine Platform: Bovine Parainfluenza Virus
© 2021 Tonix Pharmaceuticals Holding Corp. 33 TNX - 2300, 2 nd SARS - CoV - 2 Vaccine Platform: Bovine Parainfluenza (BPI) Virus Collaboration with Kansas State University to develop a vaccine candidate for the prevention of COVID - 19 • Utilizes a novel live attenuated vaccine vector platform and t
Slide 34: TNX-2100
© 2021 Tonix Pharmaceuticals Holding Corp. 34 1 TNX - 2100 is an investigational new in vivo diagnostic and has not been approved for any indication. TNX - 2100 1 • Drug Product : synthetic peptides derived from the sequence of SARS - CoV - 2 and related variants for intradermal administration • Tar
Slide 35: TNX-2100: Potential Skin Test to Measure SARS-CoV-2 Exposure and T Cell Immunity
© 2021 Tonix Pharmaceuticals Holding Corp. 35 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) • Based on mixtures of synthetic peptides for intradermal administration • Desig
Slide 36: TNX-2100: Potential Uses and Development Plans
© 2021 Tonix Pharmaceuticals Holding Corp. 36 TNX - 2100: Potential Uses and Development Plans TNX - 2100 has the potential to serve as: • a biomarker for cellular immunity and protective immunity • a method to stratify participants in COVID - 19 vaccine trials by immune status • an endpoint in COVI
Slide 37: TNX-102 SL
© 2021 Tonix Pharmaceuticals Holding Corp. 37 1 TNX - 102 SL is an investigational new drug and has not been approved for any indication. TNX - 102 SL 1 • Drug Product : cyclobenzaprine HCl – mannitol eutectic sublingual tablets for daily use at bedtime • Targeted Indications : Fibromyalgia, Posttra
Slide 38: Background on Fibromyalgia
© 2021 Tonix Pharmaceuticals Holding Corp. 38 TNX - 102 SL FM 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 last decades
Slide 39: Challenges with Current Pharmacotherapy
© 2021 Tonix Pharmaceuticals Holding Corp. 39 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 o
Slide 40: Fibromyalgia Unmet Need and Ideal Treatment Profile
© 2021 Tonix Pharmaceuticals Holding Corp. 40 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 Prof
Slide 41: TNX-102 SL: Engineered to Treat FM
© 2021 Tonix Pharmaceuticals Holding Corp. 41 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 42: TNX-102 SL 5.6 mg: Results from Completed Positive Phase 3 RELIEF Study
© 2021 Tonix Pharmaceuticals Holding Corp. 42 TNX - 102 SL 5.6 mg: Results from Completed Positive Phase 3 RELIEF Study Completed Positive Trial in FM: • Topline results announced in December 2020 • 503 participants randomized across 39 sites in U.S. • 95% of participants were women Topline Efficacy
Slide 43: Positive Phase 3 F304/RELIEF Study: Design
© 2021 Tonix Pharmaceuticals Holding Corp. 43 Positive Phase 3 F304/RELIEF Study: Design 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 rep
Slide 44: F304/RELIEF Study Topline Data: Primary Efficacy Endpoint
© 2021 Tonix Pharmaceuticals Holding Corp. 44 F304/RELIEF Study Topline Data: Statistical Significance Achieved on Pre - specified Primary Efficacy Endpoint (p=0.01) ◊ ◊ Primary Outcome Measure at Week 14 Placebo (N=255) TNX - 102 SL (N=248) Treatment Difference P value LS Mean Change from Baseline
Slide 45: F304/RELIEF Study: Primary Efficacy Endpoint Results (continued)
© 2021 Tonix Pharmaceuticals Holding Corp. 45 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 46: F304/RELIEF Study: Key Secondary Efficacy Endpoints
© 2021 Tonix Pharmaceuticals Holding Corp. 46 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 47: F304/RELIEF Study: Continuous Responder Analysis Graph
© 2021 Tonix Pharmaceuticals Holding Corp. 47 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 48: Adverse Events in F304/RELIEF Study
© 2021 Tonix Pharmaceuticals Holding Corp. 48 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 49: Safety and Tolerability in F304/RELIEF Study
© 2021 Tonix Pharmaceuticals Holding Corp. 49 Safety and Tolerability in F304/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
Slide 50: TNX-102 SL 5.6 mg for Fibromyalgia: Phase 3 F306/RALLY Study
© 2021 Tonix Pharmaceuticals Holding Corp. 50 TNX - 102 SL 5.6 mg for Fibromyalgia: 2 nd Phase 3 F306/RALLY Study 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 (NR
Slide 51: TNX-102 SL Intellectual Property – U.S. Protection expected until 2035
© 2021 Tonix Pharmaceuticals Holding Corp. 51 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 52: TNX-102 SL for Long COVID (PASC)
© 2021 Tonix Pharmaceuticals Holding Corp. 52 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 53: Opportunities to Expand TNX-102 SL to Other Indications
© 2021 Tonix Pharmaceuticals Holding Corp. 53 Opportunities to Expand TNX - 102 SL to Other Indications Growing recognition that there are many disorders where sleep disturbances may have a role in the pathophysiology (cardiovascular, metabolic, neurologic) • Sleep quality plays a homeostatic role i
Slide 54: TNX-1300
© 2021 Tonix Pharmaceuticals Holding Corp. 54 1 TNX - 1300 is an investigational new biologic and has not been approved for any indication. TNX - 1300 1 • Drug Product : recombinant T172R/G173Q double - mutant cocaine esterase, produced in E. coli, delivered as a 200 mg lyophilized drug product for
Slide 55: TNX-1300 for the Treatment of Cocaine Intoxication
© 2021 Tonix Pharmaceuticals Holding Corp. 55 TNX - 1300* for the Treatment of Cocaine Intoxication Recombinant protein that degrades cocaine in the bloodstream 1 • Double - mutant cocaine esterase ( CocE ) • CocE was identified in a bacterium ( Rhodococcus ) that use cocaine as its sole source of c
Slide 56: TNX-1300 (Cocaine Esterase) Is a Fast-acting Cocaine Antidote
© 2021 Tonix Pharmaceuticals Holding Corp. 56 TNX - 1300 (Cocaine Esterase or CocE ) Is a Fast - acting Cocaine Antidote CocE Rhodococcus bacteria living in the roots of the coca plant use CocE to metabolize cocaine 1 CocE cleaves chemical bonds in cocaine and disintegrates it 800 times faster than
Slide 57: TNX-1300 Development Plan
© 2021 Tonix Pharmaceuticals Holding Corp. 57 TNX - 1300 Development Plan • Targeting to initiate a Phase 2 open - label, randomized pilot study of TNX - 1300 in the third quarter of 2021 • Emergency department (ED) setting with patients coming in for treatment of cocaine and/or polysubstance intoxi
Slide 58: TNX-1900
© 2021 Tonix Pharmaceuticals Holding Corp. 58 1 TNX - 1900 is an investigational new drug and has not been approved for any indication. TNX - 1900 1 • Drug Product : potentiated oxytocin nasal spray solution • Targeted Indications : for the treatment of migraine, craniofacial pain, and insulin resis
Slide 59: TNX-1900 for the Treatment of Migraine and Craniofacial Pain – Overview
© 2021 Tonix Pharmaceuticals Holding Corp. 59 TNX - 1900 (Intranasal Potentiated Oxytocin) for the Treatment of Migraine and Craniofacial Pain – Overview Novel intranasal ( i.n. ) oxytocin (OT) formulation being developed as a prophylactic treatment for chronic migraine • Based on a propriety formul
Slide 60: TNX-1900 for the Treatment of Migraine – Prevalence
© 2021 Tonix Pharmaceuticals Holding Corp. 60 TNX - 1900 for the Treatment of Migraine – Prevalence One billion individuals worldwide suffer from migraines (~14% of population) 1 Migraine is the second leading cause of years lived with disability 1 In U.S., the estimated cost of all migraine headach
Slide 61: TNX-1900 for the Treatment of Migraine – Mechanism of Action
© 2021 Tonix Pharmaceuticals Holding Corp. 61 TNX - 1900 for the Treatment of Migraine – Mechanism of Action Preclinical research showed that nasally applied TNX - 1900 selectively inhibits the activity of trigeminal pain - sensing nerve cells and blocks the release of CGRP • TNX - 1900 is believed
Slide 62: TNX-1900 – Mechanism of Action (continued)
TNX - 1900 for the Treatment of Migraine – Mechanism of Action (continued) HEAD PAIN PATIENT USES TNX - 1900 TARGETED DELIVERY Permeates nasal mucosa Transported to trigeminal system and brain Proprietary Nasal to Brain Delivery CGRP: NEUROTRANSMITTER THAT HAS BEEN VALIDATED AS KEY MIGRAINE TARGET T
Slide 63: TNX-1900: Mechanism of Action (continued)
TNX - 1900: Mechanism of Action (continued) In animal models, intranasal oxytocin concentrates in the trigeminal system I nhibits trigeminal neuronal firing, and decreases CGRP (and PACP) release onto meningeal vasculature and within the brainstem - Believed to have effects on: - Neurogenic inflamma
Slide 64: TNX-1900 for the Treatment of Migraine – Development Status
© 2021 Tonix Pharmaceuticals Holding Corp. 64 TNX - 1900 for the Treatment of Migraine – Development Status In June 2020, Tonix acquired a proprietary formulation of nasal oxytocin solution for intranasal delivery from Trigemina Also acquired migraine and pain treatment technologies of Trigemina , I
Slide 65: TNX-2900
© 2021 Tonix Pharmaceuticals Holding Corp. 65 1 TNX - 2900 is an investigational new drug and has not been approved for any indication. TNX - 2900 1 • Drug Product : oxytocin nasal spray solution • Targeted Indication : for the treatment of Prader Willi Syndrome
Slide 66: TNX-2900 for the Treatment of Prader-Willi Syndrome – Overview
© 2021 Tonix Pharmaceuticals Holding Corp. 66 TNX - 2900 for the Treatment of Prader - Willi Syndrome – Overview TNX - 2900 is also based on Tonix’s patented intranasal potentiated oxytocin formulation and expands on this work Prader - Willi syndrome is the most common genetic cause of life - threat
Slide 67: TNX-601 CR
© 2021 Tonix Pharmaceuticals Holding Corp. 67 1 TNX - 601 CR is an investigational new drug and has not been approved for any indication. TNX - 601 CR 1 • Drug Product : tianeptine oxalate and naloxone HCl controlled - release tablet for once - daily use • Targeted Indications : for the treatment of
Slide 68: TNX-601 CR Tablets for the Treatment of Major Depressive Disorder
© 2021 Tonix Pharmaceuticals Holding Corp. 68 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 69: TNX-601 CR: A Potential Treatment for Depression
© 2021 Tonix Pharmaceuticals Holding Corp. 69 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 70: Tonix Approach to Abuse Liability of Tianeptine for TNX-601 CR
© 2021 Tonix Pharmaceuticals Holding Corp. 70 Tonix Approach to Abuse Liability of Tianeptine for the Development of TNX - 601 CR Addition of naloxone to formulation is designed as a deterrent to illicit parenteral abuse of crushed tablets • Naloxone is a mu - opioid antagonist that is used as a par
Slide 71: TNX-601 CR Intellectual Property – U.S. Protection expected until 2037
© 2021 Tonix Pharmaceuticals Holding Corp. 71 TNX - 601 CR Intellectual Property – U.S. Protection expected until 2037 • United States Patent and Trademark Office (USPTO) issued United States Patent No. 10,449,203 in October 2019, Patent No. 10,946,027 in March 2021. • USPTO Provisional patent filed
Slide 72: TNX-1500
© 2021 Tonix Pharmaceuticals Holding Corp. 72 1 TNX - 1500 is an investigational new drug and has not been approved for any indication. TNX - 1500 1 • Drug Product : recombinant Fc - modified anti - CD40 - ligand monoclonal antibody, from cell culture, for injection • Targeted Indications : for the
Slide 73: TNX-1500, a New CD40 Ligand Antibody, for Prevention of Allograft Rejection
© 2021 Tonix Pharmaceuticals Holding Corp. 73 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 74: Pipeline Summary – by Select Therapeutic Areas
© 2021 Tonix Pharmaceuticals Holding Corp. 74 Pipeline 1 Summary – by Select Therapeutic Areas Pain Psychiatry Addiction Medicine • TNX - 102 SL (sublingual cyclobenzaprine) for fibromyalgia Phase 3/RELIEF Phase 3/RALLY • TNX - 102 SL (sublingual cyclobenzaprine) for PTSD Phase 3/RECOVERY • TNX - 10
Slide 75: Pipeline Summary – by Select Therapeutic Areas (continued)
© 2021 Tonix Pharmaceuticals Holding Corp. 75 Pipeline 1 Summary – by Select Therapeutic Areas (continued) Oncology • TNX - 1700 (rTFF2 2 ) for treatment of gastric and pancreatic cancer Preclinical Public Health • TNX - 1800 (live modified horsepox vaccine) for preventing COVID - 19 Preclinical • T
Slide 76: Milestones – Recently Completed and Upcoming
© 2021 Tonix Pharmaceuticals Holding Corp. 76 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 77: Management Team
© 2021 Tonix Pharmaceuticals Holding Corp. 77 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 78: Thank You!
© 2021 Tonix Pharmaceuticals Holding Corp. 78 Thank You!
Tonix Pharmaceuticals Holding — Investor Presentation (August 2021) on 6ix