Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (March 2022)

68 slides from Tonix Pharmaceuticals's investor presentation, Mar 28, 2022

  1. Slide 1: Investor Presentation

    © 2022 Tonix Pharmaceuticals Holding Corp. INVESTOR PRESENTATION NASDAQ: TNXP Version P0345 March 28, 2022 (Doc 0984)

  2. Slide 2: Cautionary Note on Forward-Looking Statements

    2 © 2022 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 © 2022 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: CNS Portfolio Pipeline

    4 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CNS PORTFOLIO ADHD = attention - deficit hyperactivity disorder; FM = fibromyalgia; IND = investigational new drug; PASC = post - acute sequelae o f COVID - 19; PTSD = posttraumatic stress disorder. PIPELINE CNS PORTFOLIO Candidates* INDICAT

  5. Slide 5: Immunology and Infectious Disease Portfolio

    5 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY AND INFECTIOUS DISEASE PORTFOLIO *All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication. 1 anti - CD40L humanized monoclonal antibody 2 Recombinant trefoil factor 2 (rTFF2) ba

  6. Slide 6: CNS: Key Candidates

    © 2022 Tonix Pharmaceuticals Holding Corp. CNS: KEY CANDIDATES

  7. Slide 7: TNX-102 SL: Fibromyalgia

    7 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 102 SL*: FIBROMYALGIA CYCLOBENZAPRINE PROTECTIC ® SUBLINGUAL TABLETS CNS PORTFOLIO A unique formulation of cyclobenzaprine designed to optimize delivery and absorption Innovative and proprieta

  8. Slide 8: TNX-102 SL: Fibromyalgia Program Update

    8 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: FIBROMYALGIA PROGRAM UPDATE CNS PORTFOLIO Phase 3 Study, RALLY (F306) • As expected from interim results published July 2021, RALLY Study missed primary endpoint • Unexpected ~80% increase in adverse event - related discontinua

  9. Slide 9: RALLY Study: Increased Adverse Event-Related Discontinuations

    9 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: RALLY STUDY INCREASED ADVERSE EVENT - RELATED DISCONTINUATIONS CNS PORTFOLIO TEAE = treatment - emergent adverse event Increases in AE - Related discontinuations in RALLY study compared with RELIEF study in both placebo and TNX

  10. Slide 10: RALLY Study: Impact of Missing Data on P-Values

    10 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: RALLY STUDY IMPACT OF MISSING DATA ON P - VALUES IN RALLY MI missing data treatment attenuated p - values in RALLY • At the current time, we expect MI will be part of the statistical analysis for the RESILIENT trial CNS PORTFO

  11. Slide 11: TNX-102 SL: Fibromyalgia Program Update (RESILIENT)

    11 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: FIBROMYALGIA PROGRAM UPDATE CNS PORTFOLIO Similar to RALLY, RESILIENT will compare TNX - 102 SL 5.6 mg and placebo • Parallel design, double - blind, randomized placebo - controlled study • Primary endpoint is pain at week 14

  12. Slide 12: Role of Infections in Triggering Fibromyalgia or CFS-Like Illnesses

    12 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO ROLE OF INFECTIONS IN TRIGGERING FIBROMYALGIA OR CHRONIC FATIGUE (CFS) - LIKE ILLNESSES Infection initiates an autoreactive process, which affects several functions, including brain and energy metabolism 1 - 6 • Infections can trigger any o

  13. Slide 13: TNX-102 SL: Long COVID (PASC)

    13 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: LONG COVID a.k.a POST - ACUTE SEQUELAE OF SARS - COV - 2 INFECTION (PASC) • Long COVID is a heterogeneous condition that displays elements of nociplastic pain in many individuals, who experience otherwise unexplained 1 - 2 : •

  14. Slide 14: TNX-102 SL: Long COVID (PASC)

    14 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 102 SL*: LONG COVID (PASC) CYCLOBENZAPRINE PROTECTIC ® SUBLINGUAL TABLETS Long COVID or Post - acute Sequelae of COVID - 19 (PASC 1 ) • Symptoms can include fatigue, sleep disorders, pain, fe

  15. Slide 15: New Classification for Pain: Nociplastic

    15 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO NEW CLASSIFICATION FOR PAIN: NOCIPLASTIC Nociceptive pain Nociplastic pain Neuropathic pain Pain due to the activation of nociceptors that arises from actual or threatened damage to non - neural tissue Pain that arises from altered nocicept

  16. Slide 16: Opportunities to Expand TNX-102 SL to Other Indications

    16 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO 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 home

  17. Slide 17: TNX-1300: Cocaine Intoxication

    17 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 1300*: COCAINE INTOXICATION COCAINE ESTERASE ( CoCe ) Cocaine is the main cause for drug - related ED visits 1 Cocaine use can cause irreversible structural damage to the heart and accelerate

  18. Slide 18: TNX-1900: Migraine

    18 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued 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 •

  19. Slide 19: TNX-1900: Magnesium at the Core of Oxytocin Binding

    19 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 1900* FOR MIGRAINE MAGNESIUM (M g 2+ ) IS AT THE CORE OF OXYTOCIN BINDING 1 1 Adapted from Meyerowitz, J.G., Robertson, M.J., Barros - Álvarez, X. et al. The oxytocin signaling complex reveals a molecular switch for cation dependence.

  20. Slide 20: TNX-2900: Prader-Willi Syndrome

    20 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 2900*: PRADER - WILLI SYNDROME INTRANASAL POTENTIATED OXYTOCIN (OT) WITH MAGNESIUM CNS PORTFOLIO Prader - Willi Syndrome is the most common genetic cause of life - threatening childhood obesi

  21. Slide 21: TNX-601 CR: Depression

    21 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 601 CR*: DEPRESSION TIANEPTINE OXALATE AND NALOXONE CNS PORTFOLIO A novel, oral, controlled release once - daily tablet Mechanistically different from traditional monoaminergic treatments for

  22. Slide 22: Immunology: Key Candidates

    © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY: KEY CANDIDATES

  23. Slide 23: TNX-1500: Prophylaxis of Transplant Rejection

    23 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 ( α - CD40L m A b ): PROPHYLAXIS OF TRANSPLANT REJECTION POTENTIAL TREATMENT FOR AUTOIMMUNE CONDITIONS Pre - IND Candidate Significant Unmet Need Targeted as a first - line monotherapy for autoimmunity and add - on therapy

  24. Slide 24: TNX-1500 Market Opportunity

    24 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 MARKET OPPORTUNITY Autoimmune Disease $149.4 billion 6 OPPORTUNITY Kidney transplants: 24,000/year/US 2 $5.54 billion 3 Autoimmune Lupus: 1.5 M patients in US 4 1.87 billion 5 Organ transplant rejection drugs $4.7 billion

  25. Slide 25: About CD40L (CD154)

    25 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO ABOUT CD40L (ALSO CALLED CD154) CD40L is a transiently expressed T cell surface molecule and is also called CD154 1 - 4 ‒ Predominantly expressed by T cells and interacts with CD40 on B cells and macrophages Mediates T cell helper fu

  26. Slide 26: Next Generation Anti-CD40L Antibody TNX-1500

    26 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Patents Filed NEXT GENERATION α - CD40 LIGAND (CD40L) ANTIBODY TNX - 1500*: PREVENTION OF ALLOGRAFT REJECTION THE CD40 - CD40L PATHWAY IS A PIVOTAL IMMUNE SYSTEM MODULATOR AND IS A WELL - ESTABLISHED AND PROMISING TREATMENT TARGET TO

  27. Slide 27: Third-Generation Anti-CD40L Engineered to Decrease Thrombosis Risk

    27 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO THIRD - GENERATION anti - CD40L ENGINEERED TO DECREASE RISK OF THROMBOSIS First - generation anti - CD40L mAbs Constant fragment (Fc) domain interacted with FcγRIIA (CD32A), which suggested a mechanism for the increased risk of throm

  28. Slide 28: Anti-CD40L Treatment to Prevent Allograft Rejection

    28 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO anti - CD40L TREATMENT TO PREVENT ALLOGRAFT REJECTION • Calcineurin inhibitors (CNIs), mainly tacrolimus, are the cornerstone of immunosuppressive therapy 1,2 • However, CNIs cause irreversible and progressive deterioration of kidney

  29. Slide 29: Non-Human Primate Heart Allograft Study

    29 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO NON - HUMAN PRIMATE HEART HETEROTOPIC ALLOGRAFT STUDY DR. RICHARD PIERSON, MASS GENERAL HOSPITAL TNX - 1500 monotherapy consistently (4/5 heart transplants) prevents heart transplant rejection 1 ‒ Graft acceptance without acute cellu

  30. Slide 30: Non-Human Primate Kidney Allotransplantation Study

    30 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO NON - HUMAN PRIMATE KIDNEY ALLO - TRANSPLANTATION STUDY DR. TATSUO KAWAI, MASS GENERAL HOSPITAL TNX - 1500 monotherapy consistently (5/6 kidney transplants) prevents kidney transplant rejection 1 ‒ Six recipients were treated with TN

  31. Slide 31: Tolerance Induction with Donor Bone Marrow Transplantation

    31 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TOLERANCE INDUCTION WITH DONOR BONE MARROW TRANSPLANTATION Induction of “mixed chimerism” induces allograft tolerance ‒ Long - lasting, durable tolerance — specifically to donor tissues ‒ Initial protocols required that the recipient

  32. Slide 32: Chimerism and Kidney Transplant Results

    32 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO 0 20 40 60 80 100 5 12 20 27 33 40 47 % Chimerism Days Post CKBMT Chimerism Gran Mono Lymph Keys: 1. Bone marrow transplant 2. Kidney transplant 3. Total Body Irradition 4. Venclexta ® 5. Thymoglobulin® A. CONDITIONING REGIMEN FOR BO

  33. Slide 33: Anti-CD40L Beyond Allografts: Xenografts

    33 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO anti - CD40L BEYOND ALLOGRAFTS: XENOGRAFTS • Allotransplantation is limited by a critical shortage of human organs ; pig - to - human xenotransplantation offers a promising alternative 1,2 • Costimulation blockade (anti - CD40L in pa

  34. Slide 34: Recent Xenotransplant Headlines

    34 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO RECENT XENOTRANSPLANT HEADLINES “In a First, Surgeons Attached a Pig Kidney to a Human, and It Worked” Roni Caryn Rabin “Saved by a Pig’s Heart” The Editorial Board “Pig Kidneys Transplanted Into Brain - Dead Man as Patients Face Org

  35. Slide 35: Anti-CD40L Beyond Allografts: Autoimmunity

    35 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO anti - CD40L BEYOND ALLOGRAFTS: AUTOIMMUNITY • Autoimmune diseases are also characterized by immune system activity that attacks “self,” which can damage various parts of the body 1,2 • First - generation anti - CD40L Abs showed evid

  36. Slide 36: TNX-1500: Key Considerations

    36 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500: KEY CONSIDERATIONS • TNX - 1500 may be used in large markets that are not currently well served • There is a long history of use of monoclonal antibodies • Tonix has engineered a safer, potentially more efficacious molecu

  37. Slide 37: Development and Regulatory Strategy

    37 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO DEVELOPMENT AND REGULATORY STRATEGY • 1 st Indication – Kidney allotransplantation (human to human) ‒ Replacement for nephrotoxic CNI’s (calcineurin inhibitors, e.g. Prograf ® (tacrolimus) 1 , Neoral ® (cyclosporin) 2 ‒ Similar devel

  38. Slide 38: TNF Superfamily Members Are Targeted by mAbs

    38 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNF ߙ SUPERFAMILY MEMBERS ARE TARGETED BY mAbs • CD40L is a member of the Tumor Necrosis Factor (TNF α ) Superfamily 1 • Other TNF α Superfamily members have proven to be effective targets for antagonist (blocking) mAbs 2 anti - TNFα

  39. Slide 39: Recent Immunology Biotech Acquisitions

    39 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO 2020 September October November December 2021 January Immunomedics acquired by Gilead for $21B 1 • TRODELVY TM ( sacituzu mab govitecan - hziy ) is an anti - Trop - 2 antibody - drug conjugate (ADC) approved for triple - negative bre

  40. Slide 40: Monoclonal Antibodies Represent 4 of Top 10 Products by 2021 Sales

    40 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO MONOCLONAL ANTIBODIES ( m A bs ) REPRESENT 4 OF TOP 10 PRODUCTS BY 2021 SALES • Over 100 mAbs have been approved by the US FDA, and significant growth potential remains 1 • Global mAb market is projected to grow from $179B in 2021 to

  41. Slide 41: TNX-1700: Gastric and Colorectal Cancers

    41 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Patents Filed TNX - 1700*: GASTRIC AND COLORECTAL CANCERS STABILIZED RECOMBINANT TREFOIL FACTOR 2 ( r TFF2) POTENTIAL NEW CANCER TREATMENT • TNX - 1700 (rTFF2) has effects on cancer by altering the tumor micro - environment • Mechani

  42. Slide 42: Infectious Diseases: Key Candidates

    © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASES: KEY CANDIDATES

  43. Slide 43: TNX-801: Smallpox and Monkeypox Vaccine

    43 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Patents Filed TNX - 801: SMALLPOX AND MONKEYPOX VACCINE LIVE VIRUS PLATFORM DEVELOPMENT PROGRAM APPLICATION OF LIVE VIRUS PLATFORM • TNX - 801 is a cloned version of horsepox 1 (without any insert) purified from cell culture

  44. Slide 44: Live Virus Vaccines: Development Rationale

    44 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO LIVE VIRUS VACCINES: DEVELOPMENT RATIONALE • Control of smallpox, measles, mumps, rub ella, chickenpox and other viral conditions ‒ Prevent forward transmission • Effective in eliciting durable or long - term immunity • Econo

  45. Slide 45: Vaccinia Induces a Skin Reaction Called Take

    45 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO 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 deli very, indica

  46. Slide 46: Virus-Based Science Is Well Established

    46 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO 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 (

  47. Slide 47: Live Virus Vaccine Platform: Recombinant Pox Vaccine Technology

    47 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO LIVE VIRUS VACCINE PLATFORM: NEW RECOMBINANT POX VACCINE (RPV) TECHNOLOGY FOR EMERGING INFECTIOUS DISEASES AND ONCOLYTICS COVID - 19 Future Pandemics Infectious Disease Biodefense Using Proven Science To Address Challenging D

  48. Slide 48: COVID-19: Entering Endemic Phase in the US

    48 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO COVID - 19: ENTERING ENDEMIC PHASE IN THE US • Delta and Omicron variant waves are waning in most parts of the US ‒ Leaving a path of morbidity and mortality, including “breakthrough” infection and disease among vaccinated an

  49. Slide 49: COVID-19: The Missing Pieces

    49 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO COVID - 19: THE MISSING PIECES • Vaccines : early vaccines slowed pandemic, but are showing limitations ‒ Short term protection – requirement for boosters with mRNA vaccines; ‒ Increasing focus on preventing hospitalization a

  50. Slide 50: COVID Vaccines: Where We Are Today

    50 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO COVID - 19 VACCINES: WHERE WE ARE TODAY Durability of protection ‒ mRNA vaccinated people lose protection, starting at 4 - 6 months 1 ‒ High rates of “breakthrough” COVID during Delta and Omicron waves ‒ Booster vaccinations

  51. Slide 51: COVID Vaccines: Where Do We Go From Here?

    51 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO COVID - 19 VACCINES: WHERE DO WE GO FROM HERE? mRNA vaccines have slowed pandemic, but may not be a long - term solution ‒ Vaccinated people lost protection and showed high rates of “breakthrough” COVID during Delta and Omicr

  52. Slide 52: TNX-1840 and TNX-1850: COVID-19 Vaccine

    52 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Patents Filed TNX - 1840 AND TNX - 1850*: COVID - 19 VACCINE LIVE VIRUS PLATFORM DEVELOPMENT PROGRAM APPLICATION OF LIVE VIRUS PLATFORM • First version TNX - 1800 encodes spike protein from SARS - CoV - 2, Wuhan strain • Plan

  53. Slide 53: TNX-1840/1850 Compared with mRNA Vaccines

    53 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO LIVE VIRUS PLATFORM: WHAT MAKES TNX - 1840 AND TNX - 1850 DIFFERENT FROM m RNA VACCINES CRITERIA mRNA VACCINES TNX - 1840/TNX - 1850 Number of shots Two One Duration 6 months Years / decades Boosters Recommended Likely not re

  54. Slide 54: Internal Development and Manufacturing Capabilities

    54 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO 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

  55. Slide 55: American Pandemic Preparedness Plan (AP3)

    55 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO AMERICAN PANDEMIC PREPAREDNESS PLAN (AP3) • “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 tha

  56. Slide 56: Assessing Anti-SARS-CoV-2 Protective Immunity

    56 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO ASSESSING anti - SARS - C o V - 2 PROTECTIVE IMMUNITY 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

  57. Slide 57: TNX-2100: SARS-CoV-2 Diagnostic to Measure T Cell Immunity

    57 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO TNX - 2100*: SARS - C o V - 2 DIAGNOSTIC TO MEASURE T CELL IMMUNITY DESIGNED TO MEASURE THE PRESENCE AND STRENGTH OF FUNCTIONAL IN VIVO T CELL IMMUNITY • Designed to elicit delayed - type hypersensitivity in individuals who h

  58. Slide 58: TNX-2100: Potential Uses and Development Plan

    58 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO TNX - 2100*: POTENTIAL USES AND DEVELOPMENT PLAN *TNX - 2100 has not been approved for any indication. † Intracellular cytokine staining (ICS) measured by flow cytometry after in vitro stimulation of purified peripheral blood

  59. Slide 59: Small Molecule COVID Therapeutics

    59 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO SMALL MOLECULE COVID - 19 THERAPEUTICS 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

  60. Slide 60: TNX-3500: COVID-19 Antiviral Treatment

    60 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Patents Filed PROFILE DEVELOPMENT PROGRAM TNX - 3500*: COVID - 19 ANTIVIRAL TREATMENT SANGIVAMYCIN New variants heighten need for therapeutics NIH Treatment Guidelines for COVID - 19 are mixed on use of remdesivir Potential m

  61. Slide 61: Monoclonal Antibody COVID-19 Therapeutics

    61 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO MONOCLONAL ANTIBODY COVID - 19 THERAPEUTICS Monoclonal antibodies ( mAbs ) (EUA) – 3 with US Emergency Use Authorization 1 ‒ Vir /GSK – XEVURDY® ( sotrovimab ) 1 – ONLY mAb ACTIVE AGAINST OMICRON ‒ Lilly - bebtelovimab – EUA

  62. Slide 62: TNX-3600: COVID-19 Therapeutic

    62 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO PROFILE DEVELOPMENT PROGRAM TNX - 3600*: COVID - 1 9 THERAPEUTIC FULLY HUMAN MONOCLONAL ANTIBODY PLATFORM Collaboration with Columbia University Human monoclonal antibodies ( mAbs ) generated from COVID - 19 convalescent pati

  63. Slide 63: TNX-3700: COVID-19 Vaccine

    63 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Patents Filed PROFILE DEVELOPMENT PROGRAM TNX - 3700*: COVID - 19 VACCINE ZINC NANOPARTICLE (ZNP) FORMULATION FOR m RNA VACCINE Collaboration with Kansas State University ZNP technology is a potential replacement for the Lipi

  64. Slide 64: Future Outlook

    © 2022 Tonix Pharmaceuticals Holding Corp. FUTURE OUTLOOK

  65. Slide 65: Key Development Candidates and Partners

    65 © 2022 Tonix Pharmaceuticals Holding Corp. TNX - 1300: COCAINE INTOXICATION TNX - 1700: GASTRIC AND COLORECTAL CANCERS TNX - 3600: MONOCLONAL ANTIBODIES FOR COVID - 19 TREATMENT KEY DEVELOPMENT PARTNERS TNX - 1500: ALLOGRAFT REJECTION TNX - 1900: MIGRAINE & OTHER INDICATIONS TNX - 801: SMALLPOX A

  66. Slide 66: Milestones: Recently Completed and Upcoming

    66 © 2022 Tonix Pharmaceuticals Holding Corp. Expected Clinical Trial Initiations □ 1 st Half 2022 Phase 2 OL safety study start of TNX - 1300 in ED setting for cocaine intoxication □ 1 st Half 2022 Phase 2 study start of TNX - 102 SL for the treatment of PTSD in Kenya □ 1 st Half 2022 Phase 3 study

  67. Slide 67: Management Team

    67 © 2022 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

  68. Slide 68: Thank You

    © 2022 Tonix Pharmaceuticals Holding Corp. THANK YOU

Tonix Pharmaceuticals Holding — Investor Presentation (March 2022) on 6ix