Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (February 2025)

90 slides from Tonix Pharmaceuticals's investor presentation, Feb 6, 2025

1. Slide 1: Corporate Presentation February 2025

   © 2025 Tonix Pharmaceuticals Holding Corp. Corporate Presentation February 2025 NASDAQ: TNXP PO6043 Feb 6, 2025 (Doc 1559 )

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

   2 © 2025 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: Who We Are

   3 © 2025 Tonix Pharmaceuticals Holding Corp. Tonix is committed to developing and marketing therapeutics to treat pain, neurologic, psychiatric and addiction conditions through our central nervous system portfolio and within other areas of high unmet need , including immunology, infectious disease,

4. Slide 4: Key Clinical Programs

   4 © 2025 Tonix Pharmaceuticals Holding Corp. NDA Submission Phase 3 Phase 2 Phase 1 Indication Molecule * Fibromyalgia Granted FDA Fast Track Designation TNX - 102 SL Cyclobenzaprine HCl Sublingual Tablets Acute Stress Disorder Cocaine Intoxication Granted FDA Breakthrough Therapy Designation TNX -

5. Slide 5: CNS-Focused Fully-Integrated Biopharma

   5 © 2025 Tonix Pharmaceuticals Holding Corp. CNS - Focused Fully - Integrated Biopharma with Preclinical, Clinical and Commercial Stage Products Marketed Products • Zembrace ® and Tosymra ® indicated for the treatment of acute migraine TNX - 102 SL 1 for Fibromyalgia: FDA Decision on marketing autho

6. Slide 6: CNS: Key Development Candidates

   © 2025 Tonix Pharmaceuticals Holding Corp. CNS: KEY DEVELOPMENT CANDIDATES

7. Slide 7: TNX-102 SL Sublingual Cyclobenzaprine Tablets

   7 © 2025 Tonix Pharmaceuticals Holding Corp. TNX - 102 SL* ( Cyclobenzaprine HCl Sublingual Tablets) 5.6 mg A unique, sublingual formulation of cyclobenzaprine (CBP) designed to optimize absorption and delivery *5.6 mg once - daily at bedtime, TNX - 102 SL is an investigational new drug, its efficac

8. Slide 8: Sublingual Formulation Designed for Long-Term Bedtime Dosing

   8 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: Sublingual Formulation is Designed for Long - Term Daily Administration at Bedtime and Transmucosal Absorption • TNX - 102 SL: Proprietary sublingual formulation of cyclobenzaprine (CBP) with transmucosal absorption ‒ Innovatio

9. Slide 9: Fibromyalgia Pivotal Clinical Trial Results

   9 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL (5.6 mg) Fibromyalgia Pivotal Clinical Trial Results • Activity • First pivotal Phase 3 study ( RELIEF ) reported – December 2020 1 ‒ Statistically significant reduction in daily pain compared to placebo ( p = 0.010) • Second Ph

10. Slide 10: Fibromyalgia Regulatory Status

    10 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL (5.6 mg) Fibromyalgia Regulatory Status • NDA can be filed without abuse potential assessment studies ‒ April 2017 • Granted FDA Fast Track Designation ‒ July 2024 • Submitted NDA to FDA ‒ October 2024 • NDA a ssigned a PDUFA g

11. Slide 11: About Fibromyalgia

    11 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO About Fibromyalgia Fibromyalgia is considered a chronic overlapping pain condition (COPC) 5 - the only COPC with any FDA - approved drugs 6 Fibromyalgia is the prototypic nociplastic syndrome Multisite pain Fatigue Non - Restorative Sleep F

12. Slide 12: Large, Underserved and Dissatisfied Population

    12 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fibromyalgia is a Large, Underserved and Dissatisfied Population • More than 10 million U.S. adults are affected – predominantly women 1,2 ‒ Debilitating and life altering condition ‒ Significant economic impact • Patients have expressed di

13. Slide 13: Poor Sleep and Pain Bi-directional Reinforcing Effects

    13 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Poor Sleep and Pain have Bi - directional Reinforcing Effects 1 1 Moldofsky H, et al. J Rheumatol . 1996;23:529 – 533. 2 Grönbald M, et al. Clin Rheumatol . 1993;12(2):186 – 191 • Harvey Moldofsky – recognition of unrefreshing/non - restora

14. Slide 14: Cyclobenzaprine Oral Tablet History

    14 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Cyclobenzaprine (CBP) as an Oral Immediate Release (IR) Tablet for Muscle Spasm and Investigational Product for Fibromyalgia Oral CBP has an extensive safety record in humans for over 45 years 9 1. 1999 Merck OTC AdCom Briefing Package . 2.

15. Slide 15: Oral CBP First-Pass Metabolism

    15 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CBP and norCBP enter the brain Oral CBP Undergoes First - Pass Metabolism tongue CBP administered as a swallowed oral dose CBP undergoes “first pass” hepatic metabolism and is ~50% converted to the persistent active metabolite norCyclobenza

16. Slide 16: CBP Binding Affinities for Receptors and Transporters

    16 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CBP Binding Affinities* for Receptors and Transporters NET SERT M 1 α 1B α 1A 5 - HT 2A H 1 35 29 7.9 9.1 5.6 5.2 1.3 Cyclobenzaprine (CBP) 2.6 91 30 11 34 13 5.6 norCyclobenzaprine ( norCBP ) Antagonist Inhibitor CBP/ norCBP Activity CBP :

17. Slide 17: Simulated Pharmacokinetics of Oral CBP IR

    17 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Oral Dosing of CBP Immediate Release (IR) 10 mg In Simulated Pharmacokinetics (PK) of Day 20 Daily Bed - time Administration 14000 12000 10000 8000 6000 4000 2000 0 0 6 12 18 24 Sleep Time Awake Time Concentration [ pg /mL] Time [ hrs ] CBP

18. Slide 18: ~50% of Oral CBP Converted to norCBP

    18 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO ~50% of Oral CBP is Converted to norCBP by the Liver norCBP has “Flat” PK and Accumulates with Chronic Dosing H 3 C N CH 3 Cyclobenzaprine (CBP) Bed time dosing – blood levels peak ~5 hours after dosing and then rapidly fall to waking Dynam

19. Slide 19: norCBP Flat Blood Levels

    19 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO norCBP has “Flat” Blood Levels Over Time With Chronic Dosing of CBP IR 10 mg Over 20 Days (Simulated) 14000 12000 10000 8000 6000 4000 2000 0 0 6 12 18 24 Sleep Time Wake Time Concentration [ pg /mL] Time [ hrs ] n orCBP Simulated H 3 C N H

20. Slide 20: Multi-Dose PK of Simulated Oral CBP-IR

    20 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Multi - Dose PK of Simulated Oral CBP - IR 10 mg Steady State at Day 20 Steady State PK (after 20 days dosing) 14000 12000 10000 8000 6000 4000 2000 0 0 6 12 18 24 Sleep Time Wake Time Concentration [ pg /mL] Time [ hrs ] CBP Simulated norC

21. Slide 21: Transmucosal CBP Bypasses First-Pass Metabolism

    21 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CBP enters the brain directly via the circulatory system TNX - 102 SL: Transmucosal CBP Bypasses First - Pass Metabolism tongue TNX - 102 SL is administered sublingually The sublingual tablet rapidly disintegrates, dissolves and releases so

22. Slide 22: Basic Excipient Increases Systemic Absorption

    22 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Formulation with Basic Excipient Increases Systemic Absorption of Sublingual Cyclobenzaprine 1 Concentration gradient increases diffusion of free base across oral mucosa (Le Chatelier’s Principle) CBP - HCl Cyclobenzaprine free base Oral mu

23. Slide 23: Proprietary Eutectic Formulation

    23 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: Proprietary Eutectic Formulation Proprietary Cyclobenzaprine HCl Eutectic Mixture Stabilizes Sublingual Tablet Formulation Base particle (K 2 HPO 4 ) Base particle (K 2 HPO 4 ) Base particle (K 2 HPO 4 ) C y cl o be n z a p r

24. Slide 24: CBP Detected in Plasma Within Minutes

    24 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: CBP Detected in Plasma Within Minutes Following Sublingual Administration Plasma Concentration Versus Time of TNX - 102 SL Compared to CBP - IR 0 0.5 1.0 1.5 Concentration (ng/L) 2500 1500 1000 500 2000 0 TNX - 102 SL 2.8mg CB

25. Slide 25: Steady State PK of Daily Sublingual TNX-102 SL

    25 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Steady State PK on Day 20 of Daily Sublingual TNX - 102 SL (5.6 mg) Steady State PK (after 20 days dosing) 14000 12000 10000 8000 6000 4000 2000 0 0 6 12 18 24 Sleep Time Awake Time Concentration [ pg /mL] Time [ hrs ] CBP norCBP With repea

26. Slide 26: Multi-Dose PK Differentiation from Oral CBP-IR

    26 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: Multi - Dose PK Differentiation from Simulated Oral CBP - IR Day 20 TNX - 102 SL 5.6 mg v. Simulated Oral IR 10 mg Steady State PK (after 20 days dosing) 14000 12000 10000 8000 6000 4000 2000 0 0 6 12 18 24 Sleep Time Awake Ti

27. Slide 27: Sublingual Formulation Designed for Long-Term Daily Administration

    27 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: Sublingual Formulation is Designed for Long - Term Daily Administration at Bedtime and Transmucosal Absorption • Cyclobenzaprine (CBP) - Tertiary Amine Tricyclic (TAT) ‒ Dynamic pharmacokinetics (PK) ▪ Elimination by N - glucu

28. Slide 28: Patents and Patent Applications

    28 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: Patents and Patent Applications • U.S. Composition:* • A 75:25 cyclobenzaprine HCl - mannitol eutectic (dependent claims add a basifying agent). • 5 US Patents (Expire November 2034) • 1 Pending US Application (Would expire No

29. Slide 29: Nociplastic Pain: The Third Primary Type of Pain

    29 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO The Third Primary Type of Pain: Nociplastic Pain 1 - 5 Nociplastic syndrome includes: (1) widespread pain (2) fatigue (3) sleep disturbances (4) cognitive dysfunction (“brain fog”) Nociplastic Pain Examples: Fibromyalgia CFS / ME* Long COVI

30. Slide 30: Fibromyalgia from Chronic Pain or Prior Stress

    30 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fibromyalgia is Believed to Result from Chronic Pain or Prior Stress Experiences Stresses that may precede or precipitate FM include : Chronic nociceptive pain • e.g. , osteoarthritis Chronic neuropathic pain • e.g. , diabetic neuropathy In

31. Slide 31: Common Chronic Conditions are a Challenge for Pharma

    31 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Common Chronic Conditions are a Challenge for Pharma Fibromyalgia is a common chronic disease 1 • Chronic pain syndrome that persists for years or decades No animal model is recognized for nociplastic syndromes or its component symptoms • W

32. Slide 32: Challenge for Society: The Opioid Crisis

    32 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Common Chronic Conditions are a Challenge for Society The Opioid Crisis in the U.S. was driven by mistreatment of chronic pain, which was often nociplastic pain • The e pidemic of prescription pain killers was addressed by regulations which

33. Slide 33: Current FDA-Approved Fibromyalgia Drugs

    33 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Current FDA - Approved Fibromyalgia Drugs 1 1 The three drugs with FDA approval for the management of fibromyalgia are Pregabalin (Lyrica); Duloxetine (Cymbalta); Milnacipran ( Savella ) 2 Leung MTY, et al. JAMA Netw Open. 2024;7(11):e24444

34. Slide 34: ~50% of Fibromyalgia Patients on Medicare

    34 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO ~50% of U.S. Fibromyalgia Patients are on Medicare: Prescription Coverage in Medicare Stands to Benefit from Changes in IRA Approximately 50% of fibromyalgia patients are on Medicare ‒ EVERSANA analysis of claims database consisting of 2.2M

35. Slide 35: Prescriber Dissatisfaction with Available Medications

    35 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Prescribers Interviewed Expressed Broad Dissatisfaction with Available Fibromyalgia Medications: Results of Primary Research 1 Perspectives on FM Therapies from Prescribers Interviewed Negatives Positives Drug • Tolerability issues: worseni

36. Slide 36: Opportunity for a New Fibromyalgia Treatment Option

    36 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Opportunity for a New, Unique Fibromyalgia Treatment Option: Results of Primary Research from EVERSANA 1,2 • Prescribers indicate a very high unmet need in FM (ranked ≥4.0 on a 5 - point scale) • Prescribers report there is no standard of c

37. Slide 37: Off-Label Drugs Prescribed to Fibromyalgia Patients

    37 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Many Fibromyalgia Patients are Prescribed Off - Label Drugs; ~53% FM Patients Prescribed Opioids Off - Label 1 1.04% 6.03% 11.74% 12.96% 13.23% 17.58% 19.45% 20.47% 22.62% 25.50% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% Milnacipran Amitrip

38. Slide 38: Acute Stress Reaction / Acute Stress Disorder

    38 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CNS PORTFOLIO Acute Stress Reaction (ASR) / Acute Stress Disorder (ASD) ASR/ASD are acute stress conditions resulting from trauma which c an affect both civilian and military populations. Large unmet need: • According to National Center for

39. Slide 39: TNX-102 SL for ASR/ASD: Program Status

    39 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL for ASR/ASD: Program Status Status: Expect to start investigator - initiated Phase 2 in 1Q 2025 ; received IND clearance from FDA Investigator - initiated Phase 2 Trial Funded by DoD grant to University of North Carolina (UNC)

40. Slide 40: OASIS Study Design

    40 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL for ASR/ASD: Phase 2 OASIS Study Design General s tudy c haracteristics: • Randomized, double - blind, placebo - controlle d study in Acute Stress Reaction (ASR) / Acute Stress Disorder (ASD) • The proposed O ptimizing A cute S

41. Slide 41: Overlap between Fibromyalgia and Long-COVID

    41 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Significant Overlap between Fibromyalgia and Long - COVID National Institutes of Health (NIH) - sponsored RECOVER study found many Long COVID patients suffer from pain at multiple sites 1 • Suggests that many Long - COVID patients may meet

42. Slide 42: NASEM Definition of Long-COVID

    42 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO NASEM Definition of Long - COVID • In June 2024, the US National Academies of Sciences, Engineering and Medicine (NASEM) described fibromyalgia as a ‘ diagnosable condition’ in people suffering from Long COVID 1 • This definition provides g

43. Slide 43: Tonix Medicines: Marketed Products

    © 2025 Tonix Pharmaceuticals Holding Corp. TONIX MEDICINES: MARKETED PRODUCTS

44. Slide 44: Tonix Medicines: Commercial-Stage Specialty Pharma Subsidiary

    44 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tonix Medicines: Commercial - Stage Specialty Pharma Subsidiary • Tonix Medicines is a w holly - owned subsidiary of Tonix ( NASDAQ: TNXP) • Currently marketing two products indicated for the treatment of acute migraine: Zembrace ® SymTouch

45. Slide 45: Two Proprietary Migraine Drugs

    45 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tonix Medicines Markets Two Proprietary Migraine Drugs Non - oral Formulations of Sumatriptan • Each indicated for the tr eatment of acute migraine with or without aura in adults • Sumatriptan remains the acute migraine ‘gold standard’ trea

46. Slide 46: Zembrace and Tosymra Bypass the GI Tract

    46 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Zembrace and Tosymra Bypass the GI Tract Bypassing gastrointestinal (GI) tract is potential advantage for treating acute migraine • GI absorption may be inconsistent in migraineurs due to gastric stasis (also called “gastroparesis”) 1 - 4 •

47. Slide 47: Pipeline Programs and Strategy for Partnerships

    47 © 2025 Tonix Pharmaceuticals Holding Corp. Pipeline Programs and Strategy for Partnerships

48. Slide 48: Pipeline Development Strategy

    48 © 2025 Tonix Pharmaceuticals Holding Corp. Pipeline Development Strategy Focusing on government and academic collaborations • Validates Tonix’s scientific expertise and technology • Reduces internal spend • Increases number of trials • Potentially speeds tim e to market • Grants, contracts, cost

49. Slide 49: External Partnerships

    49 © 2025 Tonix Pharmaceuticals Holding Corp. External Partnerships Government partners providing direct funding, cost sharing or in - kind support include 1 : • National Institutes of Health (NIH) • National Institute of Allergy and Infectious Disease (NIAID) ▪ TNX - 1800 selected for Project NextG

50. Slide 50: Key Partnerships by Program

    50 © 2025 Tonix Pharmaceuticals Holding Corp. TNX - 1300: COCAINE INTOXICATION Key Partnerships TNX - 1500: ALLOGRAFT REJECTION TNX - 1800 : COVID - 19 VACCINE TNX - 2900: PRADER - WILLI SYNDROME TNX - 102 SL: ACUTE STRESS DISORDER TNX - 4200: BROAD - SPECTRUM ANTIVIRAL

51. Slide 51: Live Virus Vaccine Platform

    51 © 2025 Tonix Pharmaceuticals Holding Corp. TNX - 801 Live Virus Vaccine Live virus vaccine platform with multitude of potential applications

52. Slide 52: Mpox Clade Ib Public Health Emergency

    52 © 2025 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Mpox Declared Public Health Emergency of International Concern (PHEIC) by WHO* on August 14, 2024: New Clade I = “Clade Ib ” • Clade Ib - first wave in Democratic Republic of Congo (DRC) • Affects children • New mutations • ~

53. Slide 53: Mpox Outbreak 2022-23: Clade IIb

    53 © 2025 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Mpox Outbreak 2022 - 23: Clade II b Public Health Emergency Global Health Concern Risk of Spread and Lethality of Clade IIb • Case Fatality Rate (CFR): 0.1% to 3.6%  Lower compared to Clade I • Primarily spread through sexua

54. Slide 54: Monkeypox Headlines

    54 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Monkeypox Headlines • Multiple recent statements by U.S. Agencies warning about smallpox and monkeypox 1 - 6 • U.S. National Academy of Sciences Consensus Report (March 2024) 6 ‒ “Additionally, safer, single - dose vaccines and a diverse se

55. Slide 55: TNX-801 Recombinant Pox Vaccine Platform

    TNX - 801: Recombinant Pox Vaccine (RPV) Platform Using Live Virus Technology 55 C loned version of horsepox 1 purified from cell culture Key Differentiators © 2025 Tonix Pharmaceuticals Holding Corp. TNX - 801* (Horsepox) *TNX - 801 is in the pre - IND stage of development and has not been approved

56. Slide 56: TNX-801: Pre-IND Ready Mpox Vaccine

    56 © 2025 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO TNX - 801: Pre - IND Ready Candidate Mpox Vaccine • Based on synthetic horsepox - vector, believed related to first smallpox vaccine used by Dr. Edward Jenner in 1796 1 • Single - dose percutaneous 2 • Attenuated live virus 3

57. Slide 57: Safety Spectrum of Pox-based Vaccine Vectors

    57 © 2025 Tonix Pharmaceuticals Holding Corp. Illustrative Safety Spectrum Of Pox - based Vaccine Vectors as Live Virus Vaccines 20 th Century smallpox vaccines Dryvax Lister TianTan Copenhagen Tashkent MVA Canarypox Fowlpox Reactogenicity Tolerability Non - replicating vaccines Live horsepox, Recom

58. Slide 58: TNX-801 Immunogenicity and Efficacy Study Design

    58 © 2025 Tonix Pharmaceuticals Holding Corp. Challenge Vaccination Route Dose (Log 10 PFU) Virus Route Dose (Log 10 PFU) N Vaccine Group IT 5.0 MPXV (Zaire) Clade Ia Percutaneous 6.6 4 TNX - 801 (High) 1 Percutaneous 5.7 4 TNX - 801 (Low) 2 Percutaneous 5.0 4 rVACV * 3 Percutaneous - 4 Mock 4 “Take

59. Slide 59: TNX-801 Immunogenicity: Total IgG

    59 © 2025 Tonix Pharmaceuticals Holding Corp. Days Post Vaccination Baseline 28 56 TNX - 801 (HD) TNX - 801 (LD) rVACV Mock 100% Seroconversion in TNX - 801 vaccinated groups 100% Seroconversion in TNX - 801 vaccinated groups HD = “High Dose” LD = “Low Dose” Noyce RS, et al. Viruses . 2023;15(2):356

60. Slide 60: Immunogenicity: Neutralizing Antibody

    60 © 2025 Tonix Pharmaceuticals Holding Corp. TNX - 801 Vaccination – Followed by Lethal Monkeypox Clade I Challenge, Immunogenicity: Neutralizing Antibody ( PRNT 50 A ssay) Days Post Vaccination 3 28 56 60 100% Seroconversion and 88% of TNX - 801 vaccinated NHPs had neutralizing antibody responses

61. Slide 61: Clinical Signs (Lesions)

    61 © 2025 Tonix Pharmaceuticals Holding Corp. TNX - 801 Vaccination – Followed by Lethal Monkeypox Clade I Challenge, Clinical Signs (Lesions) 1 Noyce RS, et al. Viruses . 2023 Jan 26;15(2):356. doi : 10.3390/v15020356. PMID: 36851570; PMCID: PMC9965234. TNX - 801 High Dose TNX - 801 Low Dose rVACV

62. Slide 62: Clinical Disease: Lethality

    62 © 2025 Tonix Pharmaceuticals Holding Corp. TNX - 801 Vaccination – Followed by Lethal Monkeypox Clade I Challenge, Clinical Disease: Lethality No deaths in TNX - 801 vaccinated groupsx 100% survival in TNX - 801 vaccinated animals Noyce RS, et al. Viruses . 2023;15(2):356. doi : 10.3390/v15020356

63. Slide 63: TNX-1800: SARS-CoV-2 Spike Protein Vaccine

    63 © 2025 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO TNX - 1800*: Designed to Express the SARs - CoV - 2 Spike Protein TNX - 1800 (recombinant horsepox virus) is a live virus vaccine based on Tonix’s TNX - 801 that is designed to express the spike protein of the SARS - CoV - 2

64. Slide 64: Infectious Disease: Key Candidates

    © 2025 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE: KEY CANDIDATES

65. Slide 65: Host-Directed Antiviral Discovery Programs

    65 © 2025 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Host - directed antiviral discovery programs • TNX - 4200*: CD45 targeted therapeutics o Small molecule therapeutics that reduce endogenous levels of CD45, a protein tyrosine phosphatase o Reduction in CD45 protects against m

66. Slide 66: DoD DTRA Contract Awarded

    66 © 2025 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Tonix Awarded Contract from DoD Defense Threat Reduction Agency (DTRA) contract is expected to advance development of Tonix’s broad - spectrum oral antiviral program, TNX - 4200, for medical countermeasures • Other Transactio

67. Slide 67: TNX-1300 Cocaine Esterase

    67 © 2025 Tonix Pharmaceuticals Holding Corp. TNX - 1300 Cocaine Esterase Fast acting antidote for life threatening cocaine intoxication

68. Slide 68: TNX-1300: Recombinant Protein Degrades Cocaine

    TNX - 1300: Recombinant Protein Rapidly Degrades Cocaine in the Bloodstream 68 Drops plasma exposure by 90% in 2 minutes Key Differentiators © 2025 Tonix Pharmaceuticals Holding Corp. o Rapidly metabolizes cocaine within matter of minutes o N o other product currently on the market for this indicati

69. Slide 69: About Cocaine Intoxication

    69 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CNS PORTFOLIO Over 500,000 emergency department visits for cocaine, annually 3,4 About Cocaine Intoxication Over 5 million Americans reported current cocaine use in 2020, which is almost 2% of the population 1 . In 2021, more than 24,900 in

70. Slide 70: Immunology: Key Candidates

    © 2025 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY: KEY CANDIDATES

71. Slide 71: TNX-1500 Anti-CD40L Monoclonal Antibody

    71 © 2025 Tonix Pharmaceuticals Holding Corp. TNX - 1500 Anti - CD40L Monoclonal Antibody Next Generation mAb preserves efficacy without risk of thrombosis

72. Slide 72: TNX-1500: Next Generation anti-CD40L mAb

    TNX - 1500: Next Generation anti - CD40L mAb 72 Re - engineered to better modulate the binding of Fc ઻ R and mitigate risk of thrombosis Clinical Stage of Phase 1 study topline results positive Key Differentiators © 2025 Tonix Pharmaceuticals Holding Corp. Selectively Modified anti - CD40L AB Rupliz

73. Slide 73: TNX-1500 Phase 1 Topline Results and Conclusions

    73 © 2025 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 Phase 1 Topline Results and Conclusions Phase 1 design – single ascending dose study in healthy participants • Goals: Evaluate safety, pharmacodynamics and pharmacokinetics • At total of 26 participants were enrolled in th

74. Slide 74: TNX-1500 Phase 1 Results and Methods

    74 © 2025 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 Phase 1 Results and Methods Topline Results ▪ Tolerability : TNX - 1500 was generally well - tolerated with a favorable safety and tolerability profile . The only TEAE occurring in ≥ 3 participants among all TNX - 1500 gro

75. Slide 75: TNX-1500 Preclinical Data and Publications

    75 © 2025 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 Preclinical Data and Publications Non - human Primate Kidney Allo - Transplantation • TNX - 1500 monotherapy consistently prevents kidney transplant rejection with n o thrombosis observed • April 2023 Publication: Lassiter

76. Slide 76: TNX-1500 Strategy and Status

    76 © 2025 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 Strategy and Status Third Indication (and beyond): Autoimmune Diseases ( e.g., Multiple Sclerosis, Sj ö gren’s Syndrome, Systemic Lupus Erythematosus) • These indications require large studies, but represent large target m

77. Slide 77: Anti-CD40L Headlines: Pig Kidney Transplant

    77 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO ࢻ - CD40L Headlines • Mass General Hospital just transplanted a genetically engineered pig kidney into a living human 1 • Boston Globe, March 21, 2024 • Patient’s death announced May 11, 2024 2 • The patient was being treated with anti - CD

78. Slide 78: Anti-CD40L Headlines: Sanofi Frexalimab

    78 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Anti - CD40L Headlines • Sanofi published their Phase 2 data on their frexalimab in multiple sclerosis in the the New England Journal of Medicine 1 • Sanofi projects its Fc - modified humanized anti - CD40L mAb frexalimab will exceed €5 B p

79. Slide 79: TNX-1700 Recombinant TFF2-HSA Fusion Protein

    79 © 2025 Tonix Pharmaceuticals Holding Corp. TNX - 1700 Recombinant Trefoil Factor Family Member 2 (rTFF2 - HSA) Fusion Protein Targeting the toxic tumor micro - environment

80. Slide 80: TNX-1700: Targeting the Tumor Micro-Environment

    TNX - 1700: Fighting Cancer by Targeting the Tumor Micro - Environment 80 S uppresses myeloid - derived suppressor cells (MDSCs) and activates anti - cancer CD8+ T cells o Different MOA than checkpoint inhibitors o Potential synergy with anti - PD - 1 or anti - PD - L1 monoclonal antibodies Key Diff

81. Slide 81: mTNX-1700 Synergy with anti-PD1 Antibody

    81 © 2025 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO m TNX - 1700 ( m TFF2 - MSA) Showed Synergy with anti - PD1 Antibody in Inhibition of s.c. ACKP Xenograft Growth in Animals B. Tumor growth curve of s.c. implanted ACKP tumors in response to anti - PD1 antibody, mTFF2 - MSA or their

82. Slide 82: About Gastric and Colorectal Cancer

    82 © 2025 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO People living with colorectal cancer in the US 2 About Gastric and Colorectal Cancer Gastric and colorectal cancer are both leading cancers in the US. C olorectal cancer is the 3 rd leading cause of cancer - related deaths in both me

83. Slide 83: Team, Network, & Upcoming Milestones

    © 2025 Tonix Pharmaceuticals Holding Corp. TEAM, NETWORK, & UPCOMING MILESTONES

84. Slide 84: Management Team

    84 © 2025 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

85. Slide 85: Milestones: Recently Completed and Upcoming

    85 © 2025 Tonix Pharmaceuticals Holding Corp. Milestones: Recently Completed and Upcoming TNX - 102 SL for the Management of Fibromyalgia Milestones FDA Fast Track Designation granted by FDA □ 3 rd Quarter 2024 Submitted NDA to FDA for TNX - 102 SL for fibromyalgia in October 2024 □ October 2024 FDA

86. Slide 86: Thank You

    © 2025 Tonix Pharmaceuticals Holding Corp. THANK YOU

87. Slide 87: Zembrace Important Safety Information (1 of 2)

    87 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Zembrace ® Important Safety Information (1 of 2) Zembrace SymTouch ( Zembrace ) can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs

88. Slide 88: Zembrace Important Safety Information (2 of 2)

    88 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Zembrace ® Important Safety Information (2 of 2) Zembrace may cause serious side effects including: • Changes in color or sensation in your fingers and toes; sudden or severe stomach pain, stomach pain after meals, weight loss, na usea or v

89. Slide 89: Tosymra Important Safety Information (1 of 2)

    89 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tosymra® Important Safety Information (1 of 2) Tosymra® can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop Tosymra and get emergency medical help if you have any signs of heart att

90. Slide 90: Tosymra Important Safety Information (2 of 2)

    90 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tosymra may cause serious side effects including: • Changes in color or sensation in your fingers and toes; sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea,

Tonix Pharmaceuticals Holding — Investor Presentation (February 2025) on 6ix