Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (March 2025)
91 slides from Tonix Pharmaceuticals's investor presentation, Mar 24, 2025
Slide 1: Corporate Presentation March 2025
© 2025 Tonix Pharmaceuticals Holding Corp. Corporate Presentation March 2025 NASDAQ: TNXP PO6052 March 21, 2025 (Doc 1569 )
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
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,
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 -
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
Slide 6: CNS: Key Development Candidates
© 2025 Tonix Pharmaceuticals Holding Corp. CNS: Key Development Candidates
Slide 7: TNX-102 SL Cyclobenzaprine Sublingual 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
Slide 8: TNX-102 SL Sublingual Formulation Design
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
Slide 9: TNX-102 SL 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
Slide 10: TNX-102 SL 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 assigned a PDUFA go
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
Slide 12: Fibromyalgia is a Large, Underserved 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
Slide 13: Poor Sleep and Pain Have 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
Slide 14: Cyclobenzaprine as Oral Product and Sublingual Product
14 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Cyclobenzaprine (CBP) as an Oral Product for Muscle Spasm and Investigational Sublingual 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. Bennett RM
Slide 15: Cyclobenzaprine and Amitriptyline Lack Durable Activity in Fibromyalgia
15 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Neither Cyclobenzaprine nor Amitriptyline Has Durable (>1 Month) Activity on Pain in Fibromyalgia 1 * * Months Change in visual analog scale * P <0.05 vs placebo - treated group. placebo cyclobenzaprine amitriptyline Change in Visual Analog
Slide 16: Oral Tertiary Amine Tricyclics Are Prodrugs for Secondary Amine Tricyclics
16 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Oral Tertiary Amine Tricyclics (TATs) Are Prodrugs for Active Secondary Amine Tricyclics (SATs) in Depression Tertiary Amine Tricyclics Amitriptyline Nortriptyline Imipramine Desipramine Norclomipramine Doxepin Nordoxepin CH 3 CH 3 CH 3 Fir
Slide 17: Cyclobenzaprine Is a Tertiary Amine Tricyclic
17 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Cyclobenzaprine Is a Tertiary Amine Tricyclic That Was Not Developed as an Antidepressant CH 3 “First - pass” hepatic metabolism D emethylation • Cyclobenzaprine was developed as a short - term (2 - 3) week treatment for acute muscle spasm
Slide 18: Cyclobenzaprine HCl Water Solubility vs Amitriptyline HCl
18 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Cyclobenzaprine Amitriptyline Cyclobenzaprine HCl Is 66,000 Times More Water Soluble Than Amitriptyline HCl N CH 3 CH 3 2e - 2e - 2e - Antiaromaticity 10 mg/L 1,2 664,000 mg/L 3 1 Abdollahi M, et al. 3rd ed. Academic Press; 2014:838 - 845.
Slide 19: Oral Cyclobenzaprine Undergoes First-Pass Metabolism
19 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CBP and norCBP enter the brain Oral Cyclobenzaprine 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
Slide 20: Oral Cyclobenzaprine Simulated Steady-State Blood Levels
20 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Oral Cyclobenzaprine: Simulated Day 20 Steady - State Blood Levels: Secondary Amine Tricyclic norCBP Accumulates CH 3 “First - pass” hepatic metabolism Many CNS drugs have pharmacodynamic effects from rising and falling drug blood levels D
Slide 21: Cyclobenzaprine Binding Affinities for Receptors and Transporters
21 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Cyclobenzaprine 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 Ac
Slide 22: Basic Excipient Increases Transmucosal Absorption
22 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Formulation with Basic Excipient Increases Transmucosal Absorption of Sublingual Cyclobenzaprine 1 Concentration gradient increases diffusion of free base across oral mucosa (Le Chatelier’s Principle) CBP - HCl Cyclobenzaprine free base Ora
Slide 23: TNX-102 SL Proprietary Eutectic Formulation
23 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: Proprietary Eutectic Formulation Proprietary cyclobenzaprine HCl eutectic composition 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
Slide 24: CBP Detected in Plasma Within Minutes After Sublingual Administration
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
Slide 25: Transmucosal CBP Bypasses First-Pass Metabolism
25 © 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 s
Slide 26: Steady State Pharmacokinetics of Daily TNX-102 SL
26 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Steady State Pharmacokinetics of Daily Sublingual TNX - 102 SL (5.6 mg) at Bedtime 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 no
Slide 27: Multi-Dose PK Differentiation from Oral Cyclobenzaprine
27 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: Multi - Dose PK Differentiation from Simulated Oral Cyclobenzaprine (CBP) - Immediate Release (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 2
Slide 28: Sublingual Formulation Designed for Long-Term Daily Administration
28 © 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
Slide 29: TNX-102 SL Patents and Patent Applications
29 © 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
Slide 30: The Third Primary Type of Pain: Nociplastic Pain
30 © 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
Slide 31: Fibromyalgia Believed to Result from Chronic Pain or Prior Stress
31 © 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
Slide 32: Common Chronic Conditions are a Challenge for Pharma
32 © 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
Slide 33: Common Chronic Conditions are a Challenge for Society
33 © 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
Slide 34: Current FDA-Approved Fibromyalgia Drugs
34 © 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
Slide 35: ~50% of U.S. Fibromyalgia Patients are on Medicare
35 © 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
Slide 36: Prescribers Dissatisfied with Available Fibromyalgia Medications
36 © 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
Slide 37: Opportunity for a New Fibromyalgia Treatment Option
37 © 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
Slide 38: Many Fibromyalgia Patients Prescribed Off-Label Drugs
38 © 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
Slide 39: Acute Stress Reaction / Acute Stress Disorder
39 © 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
Slide 40: TNX-102 SL for ASR/ASD: Program Status
40 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL for ASR/ASD: Program Status Status: Expect to start investigator - initiated Phase 2 in 1H 2025 ; received IND clearance from FDA Investigator - initiated Phase 2 Trial Funded by DoD grant to University of North Carolina (UNC)
Slide 41: TNX-102 SL for ASR/ASD: OASIS Study Design
41 © 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
Slide 42: Significant Overlap between Fibromyalgia and Long-COVID
42 © 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
Slide 43: NASEM Definition of Long-COVID
43 © 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
Slide 44: Tonix Medicines: Marketed Products
© 2025 Tonix Pharmaceuticals Holding Corp. Tonix Medicines: Marketed Products
Slide 45: Tonix Medicines: Commercial-Stage Specialty Pharma Subsidiary
45 © 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
Slide 46: Tonix Medicines Markets Two Proprietary Migraine Drugs
46 © 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
Slide 47: Zembrace and Tosymra Bypass the GI Tract
47 © 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 •
Slide 48: Pipeline Programs and Strategy for Partnerships
48 © 2025 Tonix Pharmaceuticals Holding Corp. Pipeline Programs and Strategy for Partnerships
Slide 49: Pipeline Development Strategy
49 © 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
Slide 50: External Partnerships
50 © 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
Slide 51: Key Partnerships
51 © 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
Slide 52: TNX-801 Live Virus Vaccine
52 © 2025 Tonix Pharmaceuticals Holding Corp. TNX - 801 Live Virus Vaccine Live virus vaccine platform with multitude of potential applications
Slide 53: Mpox Declared Public Health Emergency (Clade Ib)
53 © 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 • ~
Slide 54: Mpox Outbreak 2022-23: Clade IIb
54 © 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
Slide 55: Monkeypox Headlines
55 © 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
Slide 56: TNX-801: Recombinant Pox Vaccine Platform
TNX - 801: Recombinant Pox Vaccine (RPV) Platform Using Live Virus Technology 56 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
Slide 57: TNX-801: Pre-IND Ready Candidate Mpox Vaccine
57 © 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
Slide 58: Illustrative Safety Spectrum of Pox-based Vaccine Vectors
58 © 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
Slide 59: TNX-801 Immunogenicity and Efficacy in Animals: Study Design
59 © 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
Slide 60: TNX-801 Immunogenicity: Total IgG
60 © 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
Slide 61: TNX-801 Immunogenicity: Neutralizing Antibody
61 © 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
Slide 62: TNX-801 Clinical Signs (Lesions)
62 © 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
Slide 63: TNX-801 Clinical Disease: Lethality
63 © 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
Slide 64: TNX-1800: Designed to Express SARS-CoV-2 Spike Protein
64 © 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
Slide 65: Infectious Disease: Key Candidates
© 2025 Tonix Pharmaceuticals Holding Corp. Infectious Disease: Key Candidates
Slide 66: Host-Directed Antiviral Discovery Programs
66 © 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
Slide 67: Tonix Awarded Contract from DoD DTRA
67 © 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
Slide 68: TNX-1300 Cocaine Esterase
68 © 2025 Tonix Pharmaceuticals Holding Corp. TNX - 1300 Cocaine Esterase Fast acting antidote for life threatening cocaine intoxication
Slide 69: TNX-1300: Recombinant Protein Rapidly Degrades Cocaine
TNX - 1300: Recombinant Protein Rapidly Degrades Cocaine in the Bloodstream 69 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
Slide 70: About Cocaine Intoxication
70 © 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
Slide 71: Immunology: Key Candidates
© 2025 Tonix Pharmaceuticals Holding Corp. Immunology: Key Candidates
Slide 72: TNX-1500 Anti-CD40L Monoclonal Antibody
72 © 2025 Tonix Pharmaceuticals Holding Corp. TNX - 1500 Anti - CD40L Monoclonal Antibody Next Generation mAb preserves efficacy with reduced risk of thrombosis
Slide 73: TNX-1500: Next Generation anti-CD40L mAb
TNX - 1500: Next Generation anti - CD40L mAb 73 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
Slide 74: TNX-1500 Phase 1 Topline Results and Conclusions
74 © 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
Slide 75: TNX-1500 Phase 1 Results and Methods
75 © 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
Slide 76: TNX-1500 Preclinical Data and Publications
76 © 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
Slide 77: TNX-1500 Strategy and Status
77 © 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
Slide 78: Other Anti-CD40L Monoclonal Antibodies in Development
78 © 2025 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Other ࢻ - CD40L Monoclonal Antibodies in Development Sanofi – Frexalimab , Indications: Multiple Sclerosis (MS), Systemic Lupus Erythematosus (SLE) • Sjögren’s Syndrome ( SjS ) (NCT04572841) program discontinued 1 • Phase 2 Trial in
Slide 79: Anti-CD40L Headlines
79 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Anti - CD40L Headlines • Sanofi published their Phase 2 data on their frexalimab in multiple sclerosis in the New England Journal of Medicine 1 • Sanofi projects its Fc - modified humanized anti - CD40L mAb frexalimab will exceed €5 B per y
Slide 80: TNX-1700 Recombinant TFF2-HSA Fusion Protein
80 © 2025 Tonix Pharmaceuticals Holding Corp. TNX - 1700 Recombinant Trefoil Factor Family Member 2 (rTFF2 - HSA) Fusion Protein Targeting the toxic tumor micro - environment
Slide 81: TNX-1700: Targeting the Tumor Micro-Environment
TNX - 1700: Fighting Cancer by Targeting the Tumor Micro - Environment 81 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
Slide 82: mTNX-1700 Synergy with anti-PD1 Antibody
82 © 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
Slide 83: About Gastric and Colorectal Cancer
83 © 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
Slide 84: Team, Network, & Upcoming Milestones
© 2025 Tonix Pharmaceuticals Holding Corp. TEAM, Network, & Upcoming Milestones
Slide 85: Management Team
85 © 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 Siobhan Fogarty Chief Technical Officer
Slide 86: Milestones: Recently Completed and Upcoming
86 © 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
Slide 87: Thank You
© 2025 Tonix Pharmaceuticals Holding Corp. THANK YOU
Slide 88: Zembrace Important Safety Information (1 of 2)
88 © 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
Slide 89: Zembrace Important Safety Information (2 of 2)
89 © 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
Slide 90: Tosymra Important Safety Information (1 of 2)
90 © 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 at
Slide 91: Tosymra Important Safety Information (2 of 2)
91 © 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 (March 2025) on 6ix