Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (December 2021)

38 slides from Tonix Pharmaceuticals's investor presentation, Dec 14, 2021

  1. Slide 1: Investor Presentation

    © 2021 Tonix Pharmaceuticals Holding Corp. INVESTOR PRESENTATION NASDAQ: TNXP Version P0332 December 14, 2021 (Doc 0945)

  2. 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

  3. 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

  4. Slide 4: Product Candidates Portfolio and Indication Status

    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, expressed SARS - CoV - 2 spike protein. 2 Pre - IND (Investigational New

  5. Slide 5: Pipeline: Indication Status and Next Milestone

    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 / NEXT MILESTONE CNS TNX - 102 SL 1 Fibro

  6. Slide 6: Key Candidates: COVID, Biodefense & Immunology

    © 2021 Tonix Pharmaceuticals Holding Corp. KEY CANDIDATES: COVID, BIODEFENSE & IMMUNOLOGY

  7. Slide 7: COVID-19: The Missing Pieces

    7 © 2021 Tonix Pharmaceuticals Holding Corp. • Vaccines : early vaccines slowed pandemic, but are showing limitations ‒ Short term protection – requirement for boosters; uncertain protection against variants • Anti - viral drugs : only remdesivir is available ‒ Pfizer’s PAXLOVID™ 1 looks promising;

  8. Slide 8: COVID-19 Vaccines: Where We Are Today

    8 © 2021 Tonix Pharmaceuticals Holding Corp. Durability of protection ‒ Vaccinated people lose protection, starting at 6 months 1 ‒ Increasing rates of “breakthrough” COVID ‒ White House advocating booster vaccinations with mRNA vaccines at 6 months Effect on forward transmission (spread of infectio

  9. Slide 9: COVID-19 Vaccines: Where Do We Go From Here?

    9 © 2021 Tonix Pharmaceuticals Holding Corp. mRNA vaccines have slowed pandemic, but may not be a long - term solution ‒ Vaccinated people lost protection, increasing rates of “breakthrough” COVID ‒ COVID is becoming endemic; vaccination of entire world every 6 months not practical Operation Warp Sp

  10. Slide 10: Live Virus Vaccines: Development Rationale

    10 © 2021 Tonix Pharmaceuticals Holding Corp. • Control of smallpox, measles, mumps, rub ella, chickenpox and other viral conditions ‒ Prevent forward transmission • Effective in eliciting durable or long - term immunity • Economical to manufacture at scale ‒ Low dose because replication amplifies d

  11. Slide 11: Vaccinia Induces a Skin Reaction Called Take

    11 © 2021 Tonix Pharmaceuticals Holding Corp. VACCINIA INDUCES A SKIN REACTION CALLED “TAKE” – DESCRIBED BY DR. EDWARD JENNER * Example of major cutaneous reaction, or “take,” resulting from a replication - competent live - virus vaccine with intradermal deliv ery, indicating successful vaccination

  12. Slide 12: Live Virus Vaccine Platform: Recombinant Pox Vaccine Technology

    12 © 2021 Tonix Pharmaceuticals Holding Corp. LIVE VIRUS VACCINE PLATFORM: NEW RECOMBINANT POX VACCINE (RPV) TECHNOLOGY FOR EMERGING DISEASES COVID - 19 Future Pandemics Infectious Disease Biodefense Using Proven Science To Address Challenging Disease States, We Have Created A Programmable Technolog

  13. Slide 13: Live Virus RPV Platform Profile

    13 © 2021 Tonix Pharmaceuticals Holding Corp. VIRUS - BASED SCIENCE IS WELL ESTABLISHED • Streamlined development • Ability to vertically integrate development and manufacturing • Multi - dose packaging, standard cold - chain products LIVE VIRUS RECOMBINANT POX VACCINE ( RPV ) PLATFORM PROFILE POTEN

  14. Slide 14: TNX-1800 COVID Vaccine Development Program

    14 © 2021 Tonix Pharmaceuticals Holding Corp. TNX - 1800 COVID - 19 VACCINE LIVE VIRUS PLATFORM DEVELOPMENT PROGRAM ESTABLISHES LIVE VIRUS PLATFORM • Encodes a protein from SARS - CoV - 2, the cause of COVID - 19 • Provides a novel, variant - reflexive alternative to mRNA products ANIMAL TESTING WIT

  15. Slide 15: What Makes TNX-1800 Different from mRNA Vaccines

    15 © 2021 Tonix Pharmaceuticals Holding Corp. LIVE VIRUS PLATFO RM: WHAT MAKES TNX - 1800 DIFFERENT FROM MRNA VACCINES CRITERIA mRNA VACCINES TNX - 1800* Number of shots Two One Duration 6 m onths Years / decades Boosters Recommended Likely not required Protection from variants Variants Expected For

  16. Slide 16: Internal Development & Manufacturing Capabilities

    16 © 2021 Tonix Pharmaceuticals Holding Corp. LIVE VIRUS RPV P LATFORM & 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

  17. Slide 17: American Pandemic Preparedness Plan (AP3)

    17 © 2021 Tonix Pharmaceuticals Holding Corp. • “Platforms” – Foundation of Pandemic Response ‒ Key element of AP3 from White House Office of Science and Technology Policy or OSTP 1,2 ▪ 100 days to human trials ▪ Technologies that do not require sterile injection • TNX - 801/ - 1800 (live virus RPV)

  18. Slide 18: Importance of Testing Protective Immunity

    18 © 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 • One - size - fits - all booster strategy is expensive and likely unsustainable Te

  19. Slide 19: Assessing Anti-SARS-CoV-2 Protective Immunity

    19 © 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 -

  20. Slide 20: TNX-2100: SARS-CoV-2 Diagnostic to Measure T-Cell Immunity

    20 © 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

  21. Slide 21: Small Molecule COVID-19 Therapeutics

    21 © 2021 Tonix Pharmaceuticals Holding Corp. The only COVID - 19 antiviral that is FDA approved is Remdesivir/ Veklury ® ‒ Gilead – Intravenous ( i.v. ) medicine ‒ FDA approved for patients who are at least 12 years old and require hospitalization ‒ May shorten the time to recover from acute COVID

  22. Slide 22: TNX-3500: COVID Antiviral Treatment Sangivamycin

    22 © 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 1,2 • 65 times more potent than remdesivir

  23. Slide 23: Monoclonal Antibody COVID-19 Therapeutics

    23 © 2021 Tonix Pharmaceuticals Holding Corp. Monoclonal antibodies ( mAbs ) (EUA) – 4 granted US Emergency Use Authorization 1 ‒ Regeneron/Genentech - REGEN - COV® Casirivimab /imdevimab 2 ‒ Vir /GSK – XEVURDY® ( sotrovimab ) 3 ‒ Eli Lilly – B amlanivimab /etesevimab 4 - US distribution halted 5 ‒

  24. Slide 24: TNX-3600: COVID Therapeutic Humanized Monoclonal Antibody

    24 © 2021 Tonix Pharmaceuticals Holding Corp. TNX - 3600*: COVID - 1 9 THERAPEUTIC HUMANIZED MONOCLONAL ANTIBODY PROFILE Collaboration with Columbia University Human monoclonal antibodies ( mAbs ) generated from COVID - 19 convalescent patients Potential monotherapy • Plan to seek indication similar

  25. Slide 25: TNX-SL: Long COVID Cyclobenzaprine Sublingual Tablets

    25 © 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

  26. Slide 26: TNX-1500 Next Generation CD40 Ligand Antibody

    26 © 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

  27. Slide 27: Key Candidates: CNS

    © 2021 Tonix Pharmaceuticals Holding Corp. KEY CANDIDATES: CNS

  28. Slide 28: TNX-SL: Fibromyalgia Cyclobenzaprine Sublingual Tablets

    28 © 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

  29. Slide 29: TNX-SL Fibromyalgia Program Update

    29 © 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

  30. Slide 30: TNX-CR: Psychiatry Tianeptine Oxalate and Naloxone

    30 © 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 monoaminergic treatments for depression Indirectly modulates the glutamatergic system

  31. Slide 31: TNX-1900: Migraine Intranasal Potentiated Oxytocin

    31 © 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

  32. Slide 32: TNX-2900: Prader-Willi Syndrome

    32 © 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

  33. Slide 33: TNX-1300: Cocaine Intoxication

    33 © 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

  34. Slide 34: Future Outlook

    © 2021 Tonix Pharmaceuticals Holding Corp. FUTURE OUTLOOK

  35. Slide 35: Key Development Partners

    35 © 2021 Tonix Pharmaceuticals Holding Corp. TNX - 1300: COCAINE INTOXICATION TNX - 1700: GASTRIC AND PANCREATIC CANCERS TNX - 3600: MONOCLONAL ANTIBODIES FOR COVID - 19 TREATMENT KEY DEVELOPMENT PARTNERS TNX - 1500: ALLOGRAFT REJECTION TNX - 1900: MIGRAINE & OTHER INDICATIONS TNX - 1800: COVID - 1

  36. Slide 36: Expected Data and Clinical Trial Initiations

    36 © 2021 Tonix Pharmaceuticals Holding Corp. Data □ 1 st Quarter 2022 Topline data from TNX - 102 SL Phase 3 F306/RALLY study in fibromyalgia expected Expected Clinical Trial Initiations □ 4 th Quarter 2021 Phase 2 OL safety study start of TNX - 1300 in ED setting for cocaine intoxication □ 1 st Qu

  37. Slide 37: Management Team

    37 © 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

  38. Slide 38: Thank You

    © 2021 Tonix Pharmaceuticals Holding Corp. THANK YOU

Tonix Pharmaceuticals Holding — Investor Presentation (December 2021) on 6ix