Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (March 2026)
39 slides from Tonix Pharmaceuticals's investor presentation, Mar 31, 2026
Slide 1: TNX-4800: A Long-Acting, Borreliacidal Human Monoclonal Antibody to Prevent Lyme Disease
© 2026 Tonix Pharmaceuticals Holding Corp. TNX - 4800: A Long - Acting , Borreliacidal (Bactericidal), Human Monoclonal Antibody to Prevent Lyme Disease in the U.S. NASDAQ: TNXP March 31, 2026 PO6131 March 31, 2026 1648
Slide 2: Cautionary Note on Forward-Looking Statements
2 © 2026 Tonix Pharmaceuticals Holding Corp. Cautionary Note on Forward - Looking Statements Certain statements in this presentation are forward - looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward - looking wo
Slide 3: Addressing the Significant Public Health Challenge of Lyme Disease in the U.S.
3 © 2026 Tonix Pharmaceuticals Holding Corp. Addressing the Significant Public Health Challenge of Lyme Disease in the U.S. Manufacturing GMP Material for Human Studies Currently on Track for Early 2027 Plan to Initiate Adaptive Phase 2 Field Study, Pending FDA Clearance Plan to Initiate CHIM (Contr
Slide 4: Lyme Disease: Epidemiology in the U.S.
4 © 2026 Tonix Pharmaceuticals Holding Corp. 1. U.S. Centers for Disease Control and Prevention. National Notifiable Diseases Surveillance System; maps. February 11, 2025 . A ccessed July 18, 2025. https://www.cdc.gov/lyme/data - research/facts - stats/surveillance - data - 1.html. 2. U.S. Centers f
Slide 5: Clinical Presentation: Acute Lyme Disease
5 © 2026 Tonix Pharmaceuticals Holding Corp. Clinical Presentation: Acute Lyme Disease Headache Fever/Chills Fatigue Swollen Lymph Nodes Joint and Muscle Ache Erythema Migrans Rash There are 3 stages of Lyme disease: early, early disseminated, and late 1 Early, or acute, Lyme disease has many signs
Slide 6: Current Landscape for Lyme Disease Prophylaxis and Treatment
6 © 2026 Tonix Pharmaceuticals Holding Corp. c c c c Current Landscape f or Lyme Disease Prophylaxis a nd Treatment U.S. population where Lyme disease is endemic is estimated to be 87 million 1 Recommendations for pre - exposure prevention focus on tick bite avoidance. No vaccine is currently on the
Slide 7: Lyme Disease in the U.S. and Europe Are Caused by Different Borrelia
7 © 2026 Tonix Pharmaceuticals Holding Corp. c c Lyme Disease in the U.S. and Europe are Caused by Different Borrelia • >99.9% caused by B. burgdorferi sensu stricto ( s.s. ) 1,2 • U.S. B. burgdorferi minimal genetic variability 3 • Incidence is seasonal in summer months 3 1. Marques AR, et al. Emer
Slide 8: B. burgdorferi Bacteria Are Transmitted to Humans via Tick Salivary Glands
8 © 2026 Tonix Pharmaceuticals Holding Corp. B. b urgdorferi Bacteria Are Transmitted t o Humans v ia Tick Salivary Glands 1 • The outer membrane protein OspA supports B. burgdorferi survival in the tick midgut via adherence 1 - 3 • Once the tick bites a host, the iron in a blood meal downregulates
Slide 9: OspA Facilitates Bacterial Adherence to the Tick Midgut
9 © 2026 Tonix Pharmaceuticals Holding Corp. OspA Facilitates Bacterial Adherence to the Tick Midgut, and Downregulation Promotes Migration to Salivary Glands for Transmission 1 - 3 Midgut Salivary glands Migration Adherence Osp =outer surface lipoprotein. 1. de Silva AM, et al. J Exp Med . 1996;183
Slide 10: Anti-OspA Monoclonal Antibody Ingested by Tick Blocks Transmission
10 © 2026 Tonix Pharmaceuticals Holding Corp. Circulating Anti - O spA Monoclonal Antibody (TNX - 4800) Ingested by Tick Blocks B. b urgdorferi Transmission From Tick to Human 1 B. burgdorferi Outer lipid membrane OspA/ OspC Outer membrane protein Lipoprotein BamA Bam=β - barrel assembly machinery;
Slide 11: Antibodies Can Be Created Endogenously or Received From Exogenous Sources
11 © 2026 Tonix Pharmaceuticals Holding Corp. Antibodies Can Be Created Endogenously o r Received From Exogenous Sources Active c c Natural Engineered Passive c c Natural Engineered Pathogen Exposure Vaccines Maternal Antibodies Monoclonal Antibodies Infection with a pathogen stimulates the immune s
Slide 12: Introducing TNX-4800: Human Anti-OspA Monoclonal Antibody
12 © 2026 Tonix Pharmaceuticals Holding Corp. Introducing TNX - 4800 TNX - 4800 1 is a human anti - OspA monoclonal antibody with engineered Fc domain for extended half - life, licensed from UMass Chan Medical School in 2025 c Single Injection Patient receives one subcutaneous dose expected to provi
Slide 13: Clinical and Market Acceptance of Monoclonal Antibody Preventive Treatments
13 © 2026 Tonix Pharmaceuticals Holding Corp. Clinical and Market Acceptance o f Monoclonal Antibody Preventive Treatments Monoclonal antibody prophylaxis has been approved for respiratory syncytial virus (RSV) and COVID - 19, including ENFLONSIA , 1 BEYFORTUS ® , 2 and PEMGARDA 3 1. Enflonsia . Pre
Slide 14: Not All Anti-OspA mAbs Are Bactericidal
14 © 2026 Tonix Pharmaceuticals Holding Corp. Not All anti - OspA mAbs are Bactericidal 1. Embers ME, et al. Vaccine . 2026 75:128231. doi : 10.1016/j.vaccine.2026.128231. 2. Schiller ZA, et al. J Clin Invest . 2021;131(11):e144843. 3. LYMErix was full length OspA aa 20 - 273 from B. burgdorferi str
Slide 15: Comparison with VLA15, mRNA-1975, and mRNA-1982
15 © 2026 Tonix Pharmaceuticals Holding Corp. Comparison of TNX - 4800 with VAL15, mRNA - 1975, and mRNA1982 1. Marques AR, et al. Emerg Infect Dis. 2021. 27(8):2017 - 2024. doi : 10.3201/eid2708.204763. 2. Pritt BS, et al. Lancet Infect Dis. 2016. 6(5):556 - 564. doi : 10.1016/S1473 - 3099(15)00464
Slide 16: Comparison with Alum-Adjuvanted Subunit Vaccines LYMErix and VLA15
16 © 2026 Tonix Pharmaceuticals Holding Corp. Comparison of TNX - 4800 with Alum - Adjuvanted Subunit Vaccines LYMErix (Withdrawn) and VLA15 (in Development) in Terms of OspA Targeting 1. Marques AR, et al. Emerg Infect Dis. 2021. 27(8):2017 - 2024. doi : 10.3201/eid2708.204763. 2. Pritt BS, et al.
Slide 17: Comparison: Administration Protocol and Timing of Protection
17 © 2026 Tonix Pharmaceuticals Holding Corp. Comparison of TNX - 4800 with Alum - Adjuvanted LYMErix and VAL15 Administration Protocol and Intended Timing (Onset and Duration) of Protection 1. Comstedt P, et al. PLoS One. 2014 9(11):e113294. doi : 10.1371/journal.pone.0113294 2. VALOR study missed
Slide 18: Comparison of mAb and VLA15 Vaccine: Administration and Protection Timing
18 © 2026 Tonix Pharmaceuticals Holding Corp. Comparison of TNX - 4800 (Monoclonal Antibody) and VLA15 ( Vaccine) : Administration Protocol and Intended Timing (Onset and Duration) of Protection VLA15 4,5 TNX - 4800 ( mAb ) 1,2 Criteria Pre - exposure 4 - dose vaccination regimen Pre - exposure sing
Slide 19: Comparison of Lyme Preventatives in Development
19 © 2026 Tonix Pharmaceuticals Holding Corp. Comparison of TNX - 4800 and VLA15 Lyme Preventatives in Development • TNX - 4800 is a long - acting humanA mAb (in development) against B. burgdorferi OspA • Bactericidal monoclonal antibody • TNX - 4800 showed EC 50 ≈ 0.56 μ g/mL in vitro 1 • Planned t
Slide 20: Binds to a Specific Epitope on OspA to Avoid Off-Target Effects
20 © 2026 Tonix Pharmaceuticals Holding Corp. TNX - 4800 Binds t o a Specific Epitope o n OspA to Avoid Off - Target Effects 178 - 273 71 - 141 TNX - 4800 e pitope 165 - 173 Putative arthritogenic T - cell epitope (YVLEGTLTA), mimicking LFA - 1 178 - 273 OspA Protein 1. S teere AC, et al. Arthritis
Slide 21: Target Product Profile (TPP)
21 © 2026 Tonix Pharmaceuticals Holding Corp. TNX - 4800 Target Product Profile (TPP)* Target Variable Pre - exposure prophylactic against Lyme disease Primary Indication Blood levels sufficient to provide protection within 2 - 3 days and maintained efficacy for ≥ four months Consistent with bacteri
Slide 22: Engineered Fc Mutations Extend Half-Life in Nonhuman Primates
22 © 2026 Tonix Pharmaceuticals Holding Corp. Engineered Fc Mutations Extend Half - Life of TNX - 4800 (2217LS) in Nonhuman Primates Relative to mAb 2217 1 1 Schiller ZA, et al. J Clin Invest . 2021;131(11):e144843. N=4 for each group and each dot represents one monkey. Half - lives are reported in
Slide 23: Minimum Effective Concentration #1 – in vitro Bactericidal Activity
23 © 2026 Tonix Pharmaceuticals Holding Corp. Analysis of Minimum Effective Concentration (MEC) #1 – in vitro Bactericidal Activity 1. Wang Y, et al. J Infect Dis. 2016. 214(2):205 - 11. 2. Rogers RR et al , Antimicrobial Agents and Chemotherapy , Oct. 2004, p. 3670 – 3676 • TNX - 4800 showed EC 50
Slide 24: Minimum Effective Concentration #2 – Tick Feeding Method
24 © 2026 Tonix Pharmaceuticals Holding Corp. Analysis of Minimum Effective Concentration (MEC) #2 Tick Feeding Method The monoclonal anti - OspA antibody TNX - 4800 (2217LS) inhibits tick - to - blood transmission of B. burgdorferi B31 - 5A4 in a dose - dependent manner in an artificial membrane fe
Slide 25: Minimum Effective Concentration #3 – in vivo Primate Challenge Model
25 © 2026 Tonix Pharmaceuticals Holding Corp. Analysis of Minimum Effective Concentration (MEC) #3 – in vivo Primate Challenge Model
Slide 26: Nonhuman Primate Challenge Model: Protocol and Protection by Dosage Level
26 © 2026 Tonix Pharmaceuticals Holding Corp. Nonhuman Primate Challenge Model: Protocol and Protection by Dosage Level Day - 7 0 6 14 21 28 45 63 Serum Collection 1 Jacket Acclimation Tick Challenge Tissue Biopsy Culture Observations HuMAb Injection Study Design 1 : Results: • 4 dosing cohorts, 1 i
Slide 27: Primate Challenge Model
27 © 2026 Tonix Pharmaceuticals Holding Corp. Primate Challenge Model 1. Schiller ZA, et al. J Clin Invest . 2021;131(11):e144843. • Infected ticks were placed on each non - human primate administered TNX - 4800 (N=20) for 6 days 1 • Only 1 in 20 became infected (95% protection)
Slide 28: Analysis of Minimum Effective Concentration
28 © 2026 Tonix Pharmaceuticals Holding Corp. Analysis of Minimum Effective Concentration (MEC) 1 Wang Y, et al. J Infect Dis. 2016. 214(2):205 - 11. 2 Rogers RR et al , Antimicrobial Agents and Chemotherapy, Oct. 2004, p. 3670 – 3676 3 Schiller ZA, et al. J Clin Invest . 2021;131(11):e144843. Three
Slide 29: Nonclinical Safety Data
29 © 2026 Tonix Pharmaceuticals Holding Corp. TNX - 4800: Nonclinical Safety Data • cGLP Tissue Cross Reactivity study in rat and human tissues • No significant cross - reactivity • Non - GLP pharmacokinetic and tick challenge studies in monkeys • Did not reveal a safety signal • cGLP 5 - week multi
Slide 30: Phase 1 Study Overview
30 © 2026 Tonix Pharmaceuticals Holding Corp. TNX - 4800 Phase 1 Study Overview Primary Objective : • Evaluate safety and tolerability of a SC injection of TNX - 4800 (2217LS) when administered to healthy subjects Secondary Objective : • Evaluate pharmacokinetics of a SC dose of TNX - 4800 (2217LS)
Slide 31: Human Phase 1 Study: Design
31 © 2026 Tonix Pharmaceuticals Holding Corp. Human Phase 1 Study: Safety, Tolerability and Immunogenicity: Design Sullivan - Bólyai JZ, et al. Manuscript in progress. 2025. • First - in - human, randomized, double - blind, sequential dose - escalation study (N=44) • Healthy male and female subjects
Slide 32: Phase 1 Study Results
32 © 2026 Tonix Pharmaceuticals Holding Corp. TNX - 4800 Phase 1 Study Results • No significant clinical or laboratory safety signals • The mean exposure, based on AUC - inf and C max for Cohort 4 (10mg/kg), was less than 17% of the highest exposures in the rat toxicology study • Serum TNX - 4800 (2
Slide 33: Observed Phase 1 Pharmacokinetics
33 © 2026 Tonix Pharmaceuticals Holding Corp. Observed Phase 1 Pharmacokinetics 5 μ g/ml – in vitro ~10x EC 50 10 μ g/ml – in vitro MEC tick feeding 120 days 180 days Each point represents a mean for the cohort at the specified timepoint and dose
Slide 34: Phase 1: Variability of Serum Concentrations Among Subjects
34 © 2026 Tonix Pharmaceuticals Holding Corp. TNX - 4800 Phase 1: Variability of Serum Concentrations at Sampling Time Points Among Subjects in Each Dosing Cohort Each point represents a mean for the cohort at the specified timepoint and dose The profiles for 1.5 mg/kg, 5 mg/kg and 10 mg/kg TNX - 48
Slide 35: Phase 1 Pharmacokinetics Parameters
35 © 2026 Tonix Pharmaceuticals Holding Corp. TNX - 4800 Phase 1 Pharmacokinetics Parameters Each point represents a mean for the cohort at the specified timepoint and dose 10 mg/kg 2217LS 5 mg/kg 2217LS 1.5 mg/kg 2217LS 0.5 mg/kg 2217LS Pharmacokinetic Parameters 165500000 (26.0) [n=8] 79760000 (36
Slide 36: Phase 1 Clinical Trial Summary Results
36 © 2026 Tonix Pharmaceuticals Holding Corp. Phase 1 Clinical Trial Summary Results • TNX - 4800 studied in randomized, double - blind, sequential dose - escalation study (NCT04863287) to evaluate its safety, tolerability, pharmacokinetics and immunogenicity • 44 healthy adult subjects randomized a
Slide 37: Planned Phase 2 Field Trial
37 © 2026 Tonix Pharmaceuticals Holding Corp. Planned Phase 2 Field Trial • TNX - 4800 intended to be studied in an adaptive randomized, double - blind, placebo - controlled study, pending FDA clearance • Goal: To evaluate the efficacy and safety of TNX - 4800 in preventing the first occurrence of c
Slide 38: Phase 2 Ready: Clinical Development Plans Pending FDA Clearance
38 © 2026 Tonix Pharmaceuticals Holding Corp. Phase 2 Ready: Clinical Development Plans for TNX - 4800 Pending FDA Clearance Manufacturing GMP Material for Human Studies Currently on Track for Early 2027 Plan to Initiate Adaptive Phase 2 Field Study, Pending FDA Clearance Plan to Initiate CHIM Study
Slide 39: Thank You
© 2026 Tonix Pharmaceuticals Holding Corp. THANK YOU
Tonix Pharmaceuticals Holding — Investor Presentation (March 2026) on 6ix