Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (October 2021)
29 slides from Tonix Pharmaceuticals's investor presentation, Oct 12, 2021
Slide 1: Investor Presentation
© 2021 Tonix Pharmaceuticals Holding Corp. INVESTOR PRESENTATION NASDAQ: TNXP Version P0326 October 12, 2021 (Doc 0914)
Slide 2: Cautionary Note on Forward-Looking Statements
2 © 2021 Tonix Pharmaceuticals Holding Corp. 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: Mission, What We Do and Strategy
3 © 2021 Tonix Pharmaceuticals Holding Corp. ADVANCING THE SCIENCE AND UNDERSTANDING OF DISEASES by developing innovative therapies that improve population health by focusing on unmet needs in patient care WHAT WE DO Using our integrated development engine, we advance innovative programs across mult
Slide 4: Pipeline: COVID, Biodefense & Immunology Portfolio
4 © 2021 Tonix Pharmaceuticals Holding Corp. *All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication. 1 Live attenuated vaccine based on horsepox virus vector. 2 Pre - IND meeting with the FDA completed and based on final meeting mi
Slide 5: Pipeline: CNS Portfolio
5 © 2021 Tonix Pharmaceuticals Holding Corp. ADHD = attention - deficit hyperactivity disorder; FM = fibromyalgia; IND = investigational new drug; PASC = post - acute sequelae o f COVID - 19; PTSD = posttraumatic stress disorder. Candidates INDICATION STATUS CNS TNX - 102 SL 1 Fibromyalgia (FM) Post
Slide 6: Key Candidates: COVID, Biodefense & Immunology
© 2021 Tonix Pharmaceuticals Holding Corp. KEY CANDIDATES: COVID, BIODEFENSE & IMMUNOLOGY
Slide 7: Recombinant Pox Vaccine (RPV) Platform
7 © 2021 Tonix Pharmaceuticals Holding Corp. RECOMBINANT POX VACCINE (RPV) PLATFORM: NEW VACCINE TECHNOLOGY FOR EMERGING DISEASES COVID - 19 Future Pandemics Infectious Disease Biodefense Using Proven Science To Address Challenging Disease States, We Have Created A Programmable Technology Platform A
Slide 8: RPV Platform Profile
8 © 2021 Tonix Pharmaceuticals Holding Corp. VIRUS - BASED SCIENCE IS WELL ESTABLISHED • Streamlined development • Ability to vertically integrate development and manufacturing • Highly concentrated non – cold - chain products RPV PLATFORM PROFILE POTENTIALLY LONGER DURABILITY DUE TO POX - ENGINEERE
Slide 9: TNX-1800 COVID Vaccine Development Program
9 © 2021 Tonix Pharmaceuticals Holding Corp. TNX - 1800 COVID - 19 VACCINE RPV PLATFORM DEVELOPMENT PROGRAM ESTABLISHES RPV PLATFORM • Encodes a protein from SARS - CoV - 2, the cause of COVID - 19 • Provides a novel, variant - reflexive alternative to mRNA products ANIMAL TESTING WITH SOUTHERN RESE
Slide 10: What Makes TNX-1800 Different from mRNA Vaccines
10 © 2021 Tonix Pharmaceuticals Holding Corp. RPV PLATFORM: WHAT MAKES TNX - 1800 DIFFERENT FROM MRNA VACCINES CRITERIA mRNA VACCINES TNX - 1800* Number of shots Two One Duration 8 months Years / decades Boosters Recommended Likely not required Protection from variants Variants Expected Forward tran
Slide 11: Importance of Testing Protective Immunity
11 © 2021 Tonix Pharmaceuticals Holding Corp. IMPORTANCE OF TESTING PROTECTIVE IMMUNITY • Personalized approach to determine need for vaccine boosters • More cost effective • Reduces risk with unnecessary vaccination US TRENDS IN COVID - 19 VACCINE BOOSTER DEVELOPMENT CURRENT US GOVERNMENT STANCE IS
Slide 12: Internal Development & Manufacturing Capabilities
12 © 2021 Tonix Pharmaceuticals Holding Corp. RPV PLATFORM & COVID - 19 VACCINE INTERNAL DEVELOPMENT & 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 infect
Slide 13: Two Types of Immunity
13 © 2021 Tonix Pharmaceuticals Holding Corp. TWO TYPES OF IMMUNITY • Antibodies – can be measured in a blood test, but anti - SARS - CoV - 2 antibodies are not predictive of protection • T cell – can be measured in a blood test, but requires sophisticated lab, unknown if predictive ASSESSING ANTI -
Slide 14: TNX-2100: COVID-19 Diagnostic to Confirm T-Cell Immunity
14 © 2021 Tonix Pharmaceuticals Holding Corp. MEASURES THE PRESENCE AND STRENGTH OF FUNCTIONAL IN VIVO T - CELL IMMUNITY • Designed to elicit delayed - type hypersensitivity in individuals who have been exposed to SARS - CoV - 2 or successfully vaccinated • SARS - CoV - 2 epitope peptide mixtures fo
Slide 15: TNX-3500: COVID Antiviral Treatment
15 © 2021 Tonix Pharmaceuticals Holding Corp. TNX - 3500*: COVID - 19 ANTIVIRAL TREATMENT SANGIVAMYCIN PROFILE New variants heighten need for therapeutics NIH Treatment Guidelines for COVID - 19 are mixed on use of remdesivir Potential monotherapy antiviral 1 • 65 times more potent than remdesivir i
Slide 16: TNX-102 SL: Long COVID (PASC)
16 © 2021 Tonix Pharmaceuticals Holding Corp. TNX - 102 SL: LONG COVID (PASC) CYCLOBENZAPRINE PROTECTIC ® SUBLINGUAL TABLETS PROFILE Long COVID or Post - acute Sequelae of COVID - 19 (PASC 1 ) – What is it? • Symptoms can include fatigue, sleep disorders, pain, fevers, shortness of breath, cognitive
Slide 17: TNX-1500 Next Generation CD40 Ligand Antibody
17 © 2021 Tonix Pharmaceuticals Holding Corp. TNX - 1500 NEXT GENERATION CD40 LIGAND ANTIBODY THE CD40 - CD40L PATHWAY IS A PIVOTAL IMMUNE SYSTEM MODULATOR AND IS A WELL - ESTABLISHED AND PROMISING TREATMENT TARGET TO MORE SAFELY PREVENT ALLOGRAFT REJECTION 1 1. Camilleri B, et al. Exp Clin Transpla
Slide 18: Key Candidates: CNS
© 2021 Tonix Pharmaceuticals Holding Corp. KEY CANDIDATES: CNS
Slide 19: TNX-102 SL: Fibromyalgia
19 © 2021 Tonix Pharmaceuticals Holding Corp. TNX - 102 SL: FIBROMYALGIA CYCLOBENZAPRINE PROTECTIC ® SUBLINGUAL TABLETS CNS PORTFOLIO A unique formulation of cyclobenzaprine designed to optimize delivery and absorption Innovative and proprietary PROTECTIC ® Rapid drug exposure following nighttime ad
Slide 20: TNX-102 SL: Fibromyalgia Program Update
20 © 2021 Tonix Pharmaceuticals Holding Corp. TNX - 102 SL: FIBROMYALGIA CYCLOBENZAPRINE PROTECTIC ® SUBLINGUAL TABLETS PROGRAM UPDATE 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 Mon
Slide 21: TNX-601 CR: Psychiatry
21 © 2021 Tonix Pharmaceuticals Holding Corp. TNX - 601 CR: PSYCHIATRY TIANEPTINE OXALATE AND NALOXONE CNS PORTFOLIO A novel, oral, controlled release once - daily tablet Mechanistically different from traditional MAOI treatments for depression Indirectly modulates the glutamatergic system • Bypasse
Slide 22: TNX-1900: Migraine
22 © 2021 Tonix Pharmaceuticals Holding Corp. TNX - 1900: MIGRAINE INTRANASAL POTENTIATED OXYTOCIN (OT) WITH MAGNESIUM CNS PORTFOLIO Intranasal OT has potential utility in treating migraine 1 • Intranasal OT reaches the trigeminal ganglion • Preclinical evidence of OT blocking CGRP release and suppr
Slide 23: TNX-2900: Prader-Willi Syndrome
23 © 2021 Tonix Pharmaceuticals Holding Corp. TNX - 2900: PRADER - WILLI SYNDROME INTRANASAL POTENTIATED OXYTOCIN (OT) WITH MAGNESIUM PROFILE CNS PORTFOLIO Prader - Willi Syndrome is the most common genetic cause of life - threatening childhood obesity • Orphan disease occurring in 1 in 15,000 birth
Slide 24: TNX-1300: Cocaine Intoxication
24 © 2021 Tonix Pharmaceuticals Holding Corp. TNX - 1300: COCAINE INTOXICATION COCAINE ESTERASE ( CoCe ) CNS PORTFOLIO PROFILE Cocaine is the main cause for drug - related ED visits 1 Cocaine use can cause irreversible structural damage to the heart and accelerate cardiovascular disease 2 • In one s
Slide 25: Key Development Partners
25 © 2021 Tonix Pharmaceuticals Holding Corp. TNX - 1300: COCAINE INTOXICATION TNX - 1700: GASTRIC AND PANCREATIC CANCERS KEY DEVELOPMENT PARTNERS TNX - 1500: ALLOGRAFT REJECTION TNX - 1900: MIGRAINE & OTHER INDICATIONS TNX - 1800: COVID - 19 VACCINE TNX - 2900: PRADER - WILLI SYNDROME
Slide 26: Future Outlook
© 2021 Tonix Pharmaceuticals Holding Corp. FUTURE OUTLOOK
Slide 27: Milestones: Recently Completed and Upcoming
27 © 2021 Tonix Pharmaceuticals Holding Corp. Data □ 4 th Quarter 2021 Topline data from TNX - 102 SL Phase 3 F306/RALLY study in fibromyalgia expected Clinical Trial Initiations – Three New Trials This Year □ 4th Quarter 2021 Phase 2 OL safety study of TNX - 1300 in ED setting for cocaine intoxicat
Slide 28: Management Team
28 © 2021 Tonix Pharmaceuticals Holding Corp. MANAGEMENT TEAM Seth Lederman, MD Co - Founder, CEO & Chairman Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger, CPA Chief Financial Officer
Slide 29: Thank You
© 2021 Tonix Pharmaceuticals Holding Corp. THANK YOU
Tonix Pharmaceuticals Holding — Investor Presentation (October 2021) on 6ix