Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (June 2022)

76 slides from Tonix Pharmaceuticals's investor presentation, Jun 7, 2022

  1. Slide 1: Investor Presentation

    INVESTOR PRESENTATION NASDAQ: TNXP © 2022 Tonix Pharmaceuticals Holding Corp. Version P03 53 June 1 May 9 , 2022 (Doc 10 30 )

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

    Cautionary Note on Forward - Looking Statements 2 © 2022 Tonix Pharmaceuticals Holding Corp. 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: What we do

    What we do OUR MISSION ADVANCING THE SCIENCE AND UNDERSTANDING OF DISEASES by developing innovative therapies that improve population health by focusing on unmet needs in patient care OUR STRATEGY Using our integrated development engine, we advance innovative programs across multiple therapeutic are

  4. Slide 4: Pipeline: Central Nervous System (CNS) Portfolio

    CNS PORTFOLIO Pipeline: Central Nervous System (CNS) Portfolio CANDIDATES* INDICATION STATUS / NEXT MILESTONE TNX - 102 SL 1 Fibromyalgia (FM) Posttraumatic Stress Disorder (PTSD) Long COVID (PASC 2 ) Mid - Phase 3 Phase 2, Targeted 2Q 2022 Start Phase 2, Targeted 2Q 2022 Start 3 TNX - 1300 4 Cocain

  5. Slide 5: Rare Disease & Immunology Portfolios Pipeline

    5 RARE DISEASE & IMMUNOLOGY PORTFOLIOS Pipeline Rare Disease Portfolio CANDIDATES* INDICATION STATUS / NEXT MILESTONE TNX - 2900 1 Prader - Willi Syndrome FDA Orphan Drug Designation Preclinical *All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved

  6. Slide 6: Infectious Disease Portfolio Pipeline

    6 INFECTIOUS DISEASE PORTFOLIO *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 2 Live attenuated vaccine based on horsepox virus vector, expressed SARS - CoV - 2 spike prote

  7. Slide 7: CNS: Key Candidates

    CNS: KEY CANDIDATES © 2022 Tonix Pharmaceuticals Holding Corp.

  8. Slide 8: TNX-102 SL: Fibromyalgia

    8 Patents Issued TNX - 102 SL*: Fibromyalgia Cyclobenzaprine Protectic ® Sublingual tablets © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE A unique formulation of cyclobenzaprine designed to optimize delivery and absorption Innovative and proprietary PROTECTIC ® Rapid drug exposure

  9. Slide 9: TNX-102 SL: Fibromyalgia Program Update

    9 TNX - 102 SL: Fibromyalgia Program Update © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Phase 3 Study, RESILIENT (F307), will compare TNX - 102 SL 5.6 mg and placebo • First patient enrolled in April 2022 • Interim Analysis results expected 1Q 2023 • Parallel design, double - blind, ran

  10. Slide 10: TNX-102 SL: Long COVID (PASC)

    10 Patents Issued TNX - 102 SL*: Long COVID (PASC) Cyclobenzaprine Protectic ® Sublingual Tablets PROFILE Long COVID or Post - acute Sequelae of COVID - 19 (PASC 1 ) • Symptoms can include fatigue, sleep disorders, pain, fevers, shortness of breath, cognitive impairment described as “brain fog”, gas

  11. Slide 11: Role of Infections in Triggering Fibromyalgia or CFS-Like Illnesses

    11 CNS PORTFOLIO Role of Infections in Triggering Fibromyalgia or Chronic fatigue (CFS) - Like Illnesses © 2022 Tonix Pharmaceuticals Holding Corp. Infection initiates an autoreactive process, which affects several functions, including brain and energy metabolism 1 - 6 • Infections can trigger any o

  12. Slide 12: TNX-102 SL: Long COVID a.k.a. Post-Acute Sequelae of SARS-CoV-2 Infection

    12 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 : • Symptoms (multi - site pain, fatigue, slee

  13. Slide 13: New Classification for Central Pain: Nociplastic Pain

    13 CNS PORTFOLIO New Classification for Central Pain: Nociplastic Pain 1 © 2022 Tonix Pharmaceuticals Holding Corp. 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 a

  14. Slide 14: Timeline of Long COVID After Acute COVID-19

    14 CNS PORTFOLIO Timeline of Long COVID After Acute COVID - 19 Post - Viral Syndrome 1 - 3 Week - 2 Week - 1 Week 1 Week 2 Week 3 Week 4 6 months Detection unlikely PCR positive PCR negative Acute COVID - 19 Long COVID Viral load Nasopharyngeal Respiratory tract • Chest pain • Palpitations • Thrombo

  15. Slide 15: Prevalence of Long COVID

    15 CNS PORTFOLIO Prevalence of Long COVID ~30% of Recovered SARS - CoV - 2 Patients after 6 Months Long COVID (PASC) is more prevalent among patients 1,2 : • Requiring hospitalization (93% vs 23% for those not requiring hospitalization) • With severe symptoms (2.25 times higher prevalence vs those w

  16. Slide 16: Rate of Central Sensitization in Long COVID Survey

    16 CNS PORTFOLIO Rate of Central Sensitization (CS) in Long COVID survey CS Symptoms reported in 70% 1 70% 30% 491 total participants Long COVID with CSI ≥40/100 Long COVID with CSI <40/100 1 Goudman, L, et al. J of Clin Med . 2021;10(23):5594. 2 CSI = Central Sensitization Inventory 70% of Long COV

  17. Slide 17: Long COVID Patients in TriNetX Study

    17 CNS PORTFOLIO Long COVID Patients in TriNetX Study 1 Retrospective Observational Database Study TriNetX Dataworks USA Network 2: • A federated network of inpatient and outpatient electronic medical records from 48 US healthcare organizations (HCOs) • The platform returns aggregated patient counts

  18. Slide 18: Fibromyalgia-Like Symptoms in Over 40% of Patients

    18 CNS PORTFOLIO Long COVID Patients in TriNetX study 1 Fibromyalgia - like Symptoms (Multi - Site Pain) in Over 40% of Patients 1,2 79% 13% 6% 2% 52,322 total Long COVID patients 21,694 total FM - like Long COVID patients 1 Harris, H, et al. Tonix data on file. 2022. 2 TriNetX Analytics 59% 41% Mul

  19. Slide 19: Recorded Medication Use, Days 91-180

    19 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Long COVID Patients in TriNetX Study 1 Recorded Medication Use, Days 91 - 180 15.0% 18.8% 39.8% 28.8% 34.0% 29.9% 25.9% 39.0% 35.8% 35.8% 50.1% 59.2% 43.1% 51.1% 62.8% 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Patients with compounding no

  20. Slide 20: Rate of Opioid Use in Long COVID Patients

    20 CNS PORTFOLIO 18.8% 34.0% 39.0% 50.1% 51.1% 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Percent of Patients taking Opioids Rate of Opioid Use in Long COVID Patients Potential Health Concern • In only a few days some people can develop a physical dependence and addiction to opioids 1 - 2 • The USA

  21. Slide 21: Significant Financial Impact of Long COVID

    21 CNS PORTFOLIO Significant Financial Impact of Long COVID for Households and Economies 25% of Long COVID patients are unable to return to work 1 Over 250,000 Quality Adjusted Life - Years (QUALYS) will be lost due to Long COVID in the UK 2 $23.3 billion is estimated to be paid by the UK government

  22. Slide 22: Long COVID Presidential Memorandum

    22 CNS PORTFOLIO Long COVID Presidential Memorandum President Biden – April 5, 2022 1 © 2022 Tonix Pharmaceuticals Holding Corp. Policy • Commits to redoubling efforts to address the long - term effects of COVID - 19 Organizing Government Wide Response • Harnesses the full potential of the Federal G

  23. Slide 23: Long COVID and Vaccination Recent Reports

    23 CNS PORTFOLIO Lo ng COVID and Vaccination Recent Reports 1 © 2022 Tonix Pharmaceuticals Holding Corp. Vaccination may not change risk of Long COVID after Breakthrough COVID - 19 • A retrospective cohort study of 10,024 breakthrough infection in the US showed no benefit of vaccination in decreasin

  24. Slide 24: Opportunities to Expand TNX-102 SL to Other Indications

    24 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 homeostatic role in several disorders Psychiatr

  25. Slide 25: TNX-102 SL: Posttraumatic Stress Disorder (PTSD)

    25 CNS PORTFOLIO Patents Issued TNX 102 SL*: Posttraumatic Stress disorder (PTSD) Cyclobenzaprine Protectic® Sublingual Tablets © 2022 Tonix Pharmaceuticals Holding Corp. PROFILE PTSD is a serious chronic psychiatric illness • Defined as maladaptive prolonged stress response which occurs after exper

  26. Slide 26: TNX-1300: Cocaine Intoxication

    26 © 2022 Tonix Pharmaceuticals Holding Corp. DEVELOPMENT PROGRAM Patents Issued TNX - 1300*: Cocaine Intoxication Cocaine Esterase (CocE) 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

  27. Slide 27: TNX-601 CR: Depression

    27 Patents Issued TNX - 601 CR*: Depression Tianeptine Oxalate and Naloxone © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE A novel, oral, controlled release once - daily tablet Mechanistically different from traditional monoaminergic treatments for depression Indirectly modulates t

  28. Slide 28: TNX-1900: Migraine

    28 DEVELOPMENT PROGRAM Patents Issued TNX - 1900*: Migraine Intranasal Potentiated Oxytocin (OT) with Magnesium © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE Intranasal OT has potential utility in treating migraine 1 • Intranasal OT reaches the trigeminal ganglion • Preclinical ev

  29. Slide 29: TNX-1900 for Migraine: Magnesium at the Core of Oxytocin Binding

    29 CNS PORTFOLIO TNX - 1900* for Migraine Magnesium (Mg 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. Nat Struct Mol Biol 29, 274 – 281 (2022). h

  30. Slide 30: Rare Disease: Key Candidates

    RARE DISEASE: KEY CANDIDATES © 2022 Tonix Pharmaceuticals Holding Corp.

  31. Slide 31: TNX-2900: Prader-Willi Syndrome

    31 RARE DISEASE PORTFOLIO Patents Issued TNX - 2900*: Prader - Willi Syndrome Intranasal Potentiated Oxytocin (OT) with Magnesium © 2022 Tonix Pharmaceuticals Holding Corp. PROFILE Prader - Willi Syndrome is the most common genetic cause of life - threatening childhood obesity • Rare disease occurri

  32. Slide 32: Immunology: Key Candidates

    IMMUNOLOGY: KEY CANDIDATES © 2022 Tonix Pharmaceuticals Holding Corp.

  33. Slide 33: TNX-1500 (anti-CD40L mAb): Prophylaxis of Transplant Rejection

    33 IMMUNOLOGY PORTFOLIO TNX - 1500 ( ߙ ߙ - CD40L mAb): Prophylaxis of Transplant Rejection Potential Treatment for Autoimmune Conditions Pre - IND Candidate Significant Unmet Need © 2022 Tonix Pharmaceuticals Holding Corp. Targeted as a first - line monotherapy for autoimmunity and add - on therapy

  34. Slide 34: TNX-1500 Market Opportunity

    34 IMMUNOLOGY PORTFOLIO TNX - 1500 ( ߙ ߙ - CD40 Ligand) 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 1 © 2022 Tonix Phar

  35. Slide 35: About CD40L (also called CD154)

    35 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 function 1 - 4 ‒ Activates B cells for humora

  36. Slide 36: TNX-1500: Prevention of Allograft Rejection

    IMMUNOLOGY PORTFOLIO Patents Filed TNX - 1500*: Prevention of Allograft Rejection Next Generation ߙ ߙ - CD40 Ligand (CD40L) Antibody THE CD40 - CD40L pathway is a pivotal immune system modulator and a well - established and promising treatment target SELECTIVELY MODIFIED anti - CD40L AB Ruplizumab f

  37. Slide 37: Third-Generation anti-CD40L Engineered to Decrease Risk of Thrombosis

    37 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Third - Generation α - CD40L Engineered to Decrease Risk of Thrombosis First - generation anti - CD40L mAbs Ruplizumab Constant fragment (Fc) domain interacted with FcγRIIA (CD32A), which suggested a mechanism for the increased risk

  38. Slide 38: anti-CD40L Treatment to Prevent Allograft Rejection

    38 IMMUNOLOGY PORTFOLIO ߙ ߙ - 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 function in all types of solid organ transp

  39. Slide 39: Non-Human Primate Heart Heterotopic Allograft Study

    39 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 cellular injury 2 or chronic antibody injury 3 t

  40. Slide 40: Non-Human Primate Kidney Allo-Transplantation Study

    40 IMMUNOLOGY PORTFOLIO Non - Human Primate Kidney Allo - Transplantation Study Dr. Tatsuo Kawai, Mass General Hospital No thrombosis observed ‒ Thrombosis was observed with hu5c8 in prior studies 1 TNX - 1500 monotherapy dosed at 20 mg/kg on days 0, 2, 7 and weekly until Day 180 (6 months) 2 Tacrol

  41. Slide 41: Tolerance Induction with Donor Bone Marrow Transplantation

    41 Tolerance Induction with Donor Bone Marrow Transplantation © 2022 Tonix Pharmaceuticals Holding Corp. Induction of “mixed chimerism” induces allograft tolerance ‒ Long - lasting, durable tolerance — specifically to donor tissues ‒ Initial protocols required that the recipient’s mature T cells be

  42. Slide 42: Chimerism and Kidney Transplant Survival After CKBMT

    42 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO 0 20 40 60 80 100 5 12 20 40 47 % Chimerism 27 33 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 BON

  43. Slide 43: anti-CD40L Beyond Allografts: Xenografts

    43 IMMUNOLOGY PORTFOLIO ߙ ߙ - 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 particular) is more effective at protecting xe

  44. Slide 44: Recent Xenotransplant Headlines

    44 IMMUNOLOGY PORTFOLIO Recent Xenotransplant Headlines “In a First, Surgeons Attached a Pig Kidney to a Human, and It Worked” Roni Caryn Rabin October 19, 2021 “Saved by a Pig’s Heart” The Editorial Board January 12, 2022 “Pig Kidneys Transplanted Into Brain - Dead Man as Patients Face Organ Shorta

  45. Slide 45: anti-CD40L Beyond Transplantation: Autoimmunity

    45 IMMUNOLOGY PORTFOLIO © 2022 Tonix Pharmaceuticals Holding Corp. ߙ ߙ - CD40L Beyond Transplantation: 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

  46. Slide 46: TNX-1500: Key Considerations

    46 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 molecule than previous anti - CD40L mAbs • Intell

  47. Slide 47: Development and Regulatory Strategy

    47 © 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 develop

  48. Slide 48: TNF Superfamily Members are Targeted by mAbs

    48 IMMUNOLOGY PORTFOLIO TNF ߙ ߙ Superfamily Members are Targeted by mAbs • CD40L is a member of the Tumor Necrosis Factor (TNFα) Superfamily 1 • Other TNFα Superfamily members have proven to be effective targets for antagonist (blocking) mAbs 2 anti - TNFα mAbs for the treatment of certain autoimmun

  49. Slide 49: Recent Immunology Biotech Acquisitions

    49 IMMUNOLOGY PORTFOLIO 2020 September October 2021 January Immunomedics acquired by Gilead for $21B 1 • TRODELVY TM (sacituzum ab govitecan - hziy) is an anti - Trop - 2 antibody - drug conjugate (ADC) approved for triple - negative breast cancer Momenta acquired by Johnson & Johnson for $6.5B 2 •

  50. Slide 50: Monoclonal Antibodies Represent 4 of Top 10 Products by 2021 Sales

    50 IMMUNOLOGY PORTFOLIO Monoclonal Antibodies (mAbs) Represent 4 of Top 10 Products by 2021 Sales 1 Mullard A. May 5, 2021. Accessed February 24, 2022. (https:// www.nature.com/articles/d41573 - 021 - 00079 - 7) 2 Forbes Business Insights. August 2021. Accessed February 24, 2022. (https:// www.fortu

  51. Slide 51: TNX-1700: Gastric and Colorectal Cancers

    51 IMMUNOLOGY PORTFOLIO © 2022 Tonix Pharmaceuticals Holding Corp. TNX - 1700*: Gastric and Colorectal cancers Stabilized Recombinant Trefoil Factor 2 (rTFF2) POTENTIAL NEW CANCER TREATMENT • TNX - 1700 (rTFF2) has effects on cancer by altering the tumor micro - environment • Mechanism of action: su

  52. Slide 52: Infectious Disease: Key Candidates

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

  53. Slide 53: Live Virus Vaccines: Development Rationale

    53 INFECTIOUS DISEASE PORTFOLIO © 2022 Tonix Pharmaceuticals Holding Corp. 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

  54. Slide 54: TNX-801: Smallpox and Monkeypox Vaccine

    54 INFECTIOUS DISEASE PORTFOLIO Patents Filed TNX - 801: Smallpox and Monkeypox Vaccine Live Virus Platform Development Program © 2022 Tonix Pharmaceuticals Holding Corp. APPLICATION OF LIVE VIRUS PLATFORM • TNX - 801 is a cloned version of horsepox 1 (without any insert) purified from cell culture

  55. Slide 55: Vaccinia and Horsepox Induce a Skin Reaction Called a "Take"

    55 INFECTIOUS DISEASE PORTFOLIO Vaccinia and Horsepox Induce a Skin Reaction Called a “Take” Described by Dr. Edward Jenner *Example of major cutaneous reaction, or “take,” resulting from a replication - competent live - virus vaccine with intradermal delivery, indicating successful vaccination 1,2

  56. Slide 56: Live Virus Recombinant Pox Vaccine (RPV) Platform Profile

    56 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 (RPV) Platform Profile POTENTIALLY LONGER DU

  57. Slide 57: Live Virus Vaccine Platform: Recombinant Pox Vaccine Technology

    57 INFECTIOUS DISEASE PORTFOLIO Live Virus Vaccine Platform: Recombinant Pox Vaccine (RPV) Technology for Emerging Infectious Diseases and Oncolytics Future Pandemics COVID - 19 Biodefense Vaccinia Horsepox ANTIGEN CODING Infectious Disease Oncology RPV VECTOR BELIEVED SIMILAR TO EDWARD JENNER’S VAC

  58. Slide 58: COVID-19: Entering Endemic Phase in the US

    58 INFECTIOUS DISEASE PORTFOLIO 4 Keeton R et al., “T cell responses to SARS - CoV02 spike cross - recognize omicron.” Nature Jan 31, 2022 . ( www.nature.com/articles/s41586 - 022 - 04460 - 3) © 2022 Tonix Pharmaceuticals Holding Corp. COVID - 19: Entering Endemic Phase in the US • Delta and Omicron

  59. Slide 59: COVID-19: The Missing Pieces

    59 INFECTIOUS DISEASE PORTFOLIO could - reshape - us - policy?) © 2022 Tonix Pharmaceuticals Holding Corp. 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

  60. Slide 60: COVID Vaccines: Where We Are Today

    60 © 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

  61. Slide 61: COVID Vaccines: Where Do We Go From Here?

    61 INFECTIOUS DISEASE PORTFOLIO © 2022 Tonix Pharmaceuticals Holding Corp. 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

  62. Slide 62: TNX-1840 and TNX-1850: COVID-19 Vaccine

    62 INFECTIOUS DISEASE PORTFOLIO Patents Filed TNX - 1840 and TNX - 1850*: COVID - 19 Vaccine Live Virus Platform Development Program © 2022 Tonix Pharmaceuticals Holding Corp. • First version TNX - 1800 encodes spike protein from SARS - CoV - 2, Wuhan strain • Planned new versions TNX - 1840 and TNX

  63. Slide 63: What Makes TNX-1840 and TNX-1850 Different from mRNA Vaccines

    63 INFECTIOUS DISEASE PORTFOLIO © 2022 Tonix Pharmaceuticals Holding Corp. Live Virus Platform: What Makes TNX - 1840 and TNX - 1850 Different from mRNA Vaccines CRITERIA mRNA VACCINES TNX - 1840/TNX - 1850 Number of shots Two One Duration 6 months Years / decades Boosters Recommended Likely not req

  64. Slide 64: TNX-2300: COVID-19 Vaccine Based on Bovine Parainfluenza Virus

    64 INFECTIOUS DISEASE PORTFOLIO Patents Filed TNX - 2300*: COVID - 19 Vaccine Live Virus Vaccine Based on Bovine Parainfluenza (BPI) Virus © 2022 Tonix Pharmaceuticals Holding Corp. • Previously has been shown to be an effective antigen delivery vector in humans, notably well tolerated in infants an

  65. Slide 65: Internal Development & Manufacturing Capabilities

    65 INFECTIOUS DISEASE PORTFOLIO © 2022 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

  66. Slide 66: American Pandemic Preparedness Plan (AP3)

    66 INFECTIOUS DISEASE PORTFOLIO © 2022 Tonix Pharmaceuticals Holding Corp. 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

  67. Slide 67: Small Molecule COVID Therapeutics

    67 INFECTIOUS DISEASE PORTFOLIO © 2022 Tonix Pharmaceuticals Holding Corp. 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 h

  68. Slide 68: TNX-3500: COVID-19 Antiviral Treatment

    INFECTIOUS DISEASE PORTFOLIO Patents Filed TNX - 3500*: COVID - 19 Antiviral Treatment Sangivamycin © 2022 Tonix Pharmaceuticals Holding Corp. PROFILE New variants heighten need for therapeutics NIH Treatment Guidelines for COVID - 19 are mixed on use of remdesivir Potential monotherapy antiviral 1,

  69. Slide 69: Monoclonal Antibody COVID-19 Therapeutics

    69 INFECTIOUS DISEASE PORTFOLIO © 2022 Tonix Pharmaceuticals Holding Corp. Monoclonal Antibody COVID - 19 Therapeutics Monoclonal antibodies (mAbs) (EUA) – 3 with US Emergency Use Authorization 1 ‒ Vir/GSK – XEVURDY® (sotrovimab) 1 – ONLY mAb that was active against omicron, but now withdrawn from d

  70. Slide 70: TNX-3600: COVID Therapeutics Fully Human mAb Platform

    70 INFECTIOUS DISEASE PORTFOLIO TNX - 3600*: COVID - 1 9 Therapeutics Fully Human Monoclonal Antibody Platform PROFILE Collaboration with Columbia University Human monoclonal antibodies (mAbs) generated from COVID - 19 convalescent patients Potential monotherapies • Plan to seek indication similar t

  71. Slide 71: TNX-3700: COVID-19 Vaccine Zinc Nanoparticle Formulation

    71 INFECTIOUS DISEASE PORTFOLIO Patents Filed TNX - 3700*: COVID - 19 Vaccine Zinc Nanoparticle (ZNP) Formulation for mRNA Vaccines © 2022 Tonix Pharmaceuticals Holding Corp. PROFILE Collaboration with Kansas State University ZNP technology is a potential replacement for the Lipid Nanoparticle (LNP)

  72. Slide 72: Future Outlook

    FUTURE OUTLOOK © 2022 Tonix Pharmaceuticals Holding Corp.

  73. Slide 73: Key Development Partners

    73 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 AND MONKEYPOX VACCINE TNX - 1840 and TNX - 1

  74. Slide 74: Expected Clinical Trial Initiations and Milestones

    74 Expected Clinical Trial Initiations □ 2 nd Quarter 2022 Phase 2 OL safety study start of TNX - 1300 in ED setting for cocaine intoxication □ 2 nd Quarter 2022 Phase 2 study start of TNX - 102 SL for the treatment of PTSD in Kenya □ 2 nd Quarter 2022 Phase 2 study start of TNX - 102 SL for the tre

  75. Slide 75: Management Team

    75 Management Team Seth Lederman, MD Co - Founder, CEO & Chairman Gregory Sullivan, MD Chief Medical Officer Bradley Saenger, CPA Chief Financial Officer Jessica Morris Chief Operating Officer © 2022 Tonix Pharmaceuticals Holding Corp.

  76. Slide 76: Thank You

    THANK YOU © 2022 Tonix Pharmaceuticals Holding Corp.

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