Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — World Vaccine Congress 2026
25 slides from Tonix Pharmaceuticals's conference presentation, Mar 30, 2026
Slide 1: A Long-Acting Monoclonal Antibody for Seasonal Prevention of Lyme Disease
A Long-Acting Monoclonal Antibody for Seasonal Prevention of Lyme Disease Mark S. Klempner, MD Professor of Medicine March 30, 2026 World Vaccine Congress UMass Chan Medical School
Slide 2: Disclosures
Disclosures Co-Inventor US Patent 10,457,721 Consultant Tonix Pharmaceuticals, Inc Support from National Center for Advancing Translational Sciences (NCATS) NIH, DARPA, DOD Tick Borne Disease Research Program, and NIAID UMass Chan Medical School
Slide 3: Growing Unmet Need: Prevention of Lyme Disease
Growing Unmet Need: Prevention of Lyme Disease • Lyme disease is the most common tick-borne illness (80% of all tick- borne diseases) in the Northern hemisphere. The CDC estimates over 450,000 cases annually. • Global changes in climate is a factor in the expanding habitat range for ticks and other
Slide 4: Preventing Lyme Disease: Vaccine Compared to Antibody Pre-Exposure Prophylaxis
Preventing Lyme Disease Vaccine Compared to Antibody Pre-Exposure Prophylaxis Vaccination Person receives 3 injections over 6 months of Lyme bacteria proteins and develops many different antibodies. Tick carrying the Lyme disease bacteria bites the Lyme bacteria vaccinated person, takes in blood for
Slide 5: Discovery of mAB 221-7 with Potent Bactericidal Activity and Coverage of Three OspA Serotypes
Discovery of mAB 221-7 with Potent Bactericidal Activity and Coverage of Three OspA Serotypes The Target Outer surface protein A (OspA) of the Spirochete • Essential for survival while in tick midgut • Anti-OspA immunity is effective in both animals and humans Approach 5 UMass Chan Medical School
Slide 6: Discovery of mAb 221-7 with Strong Potency and Coverage
Discovery of mAb 221-7 with Strong Potency and Coverage In vitro Borreliacidal assay against three Borrelia strains Antibody In vitro Potency and Coverage Borreliacidal assay Burgdorferi, afzelii, and garinii 4 leads were selected for animal study 319-44, 221-7, 857-2 and 221-55 In vivo Potency Mous
Slide 7: Identified Four Lead anti-OspA Borrelia Antibodies
Identified Four Lead anti-OspA Borrelia Antibodies 7 UMass Chan Medical School
Slide 8: mAb 221-7 Epitope Resolved by Crystallization
mAb 221-7 Epitope Resolved by Crystallization 8 UMass Chan Medical School
Slide 9: mAb 221-7 Does not Recognize the Putative Arthritogenic T-cell Epitope
mAb 221-7 Does not Recognize the Putative Arthritogenic T-cell Epitope 71-141 178-273 OspA Protein 221-7 Epitope 165-173 Putative arthritogenic T-cell epitope (YVLEGTLTA), mimicking human leukocyte function-associated antigen-1 (hLFA-1) 9 UMass Chan Medical School
Slide 10: Half-Life Extension in FcRn Mice and NHP: TNX-4800 (2217LS)
Half-Life Extension in FcRn Mice and NHP: TNX-4800 (2217LS) Mouse PK Monkey PK Antibody Serum Concentration (ug/mL) Antibody Serum Concentration (ug/mL) 100 2217, 1 mg/kg 1000 2217, 10 mg/kg 2217LS, 1 mg/kg 2217LS, 10 mg/kg 10 100 1 10 0.1 0.01 1 0 10 20 30 40 50 0 10 20 30 40 50 60 70 80 90 100 Tim
Slide 11: Blocking Borrelia burgdorferi Transmission from Infected Ticks to Non-Human Primates with TNX-4800
Blocking Borrelia burgdorferi Transmission from Infected Ticks to Non-Human Primates with TNX-4800 (2217-LS) Jacket Acclimation Tick Challenge Tissue Biopsy Culture Observations Day -7 0 1 6 14 21 28 45 63 HuMAb Injection Serum Collection 4-6 animals each dose group Dose Protection Monoclonal Antibo
Slide 12: Estimating Minimum Effective Concentration of TNX-4800 in Non-Human Primates
Estimating Minimum Effective Concentration of TNX-4800 (2217-LS) in Non-Human Primates Serum levels above 21 µg/mL were ~95% protective. 12 UMass Chan Medical School
Slide 13: Minimum Effective Concentration (MEC) TNX-4800 (2217-LS)
Minimum Effective Concentration (MEC) TNX-4800 (2217-LS) • ~5 μg/mL – in vitro bactericidal activity • TNX-4800 showed EC50 ≈ 0.56 μg/mL in vitro1 • MEC ~ 10X EC50 • <10 μg/mL – in vitro tick feeding experiment • TNX-4800 showed bactericidal activity ≥10 μg/ml • <21 μg/mL – in vivo primate challenge
Slide 14: Nonclinical Safety Data
Nonclinical Safety Data TNX-4800 ▪ 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 multiple dose study with 4 week recovery in rats and a cGLP
Slide 15: UMass Chan Medical School, Celerion and MassBiologics
Z UMass Chan MEDICAL SCHOOL Celerion & MassBiologics February UMass Chan Medical School 15
Slide 16: TNX-4800 Phase 1 Study Overview
TNX-4800 Phase 1 Study Overview Primary Objective: Cohort N1 Treatment 2217LS Dose Route • Evaluate safety and tolerability of (mg/kg) a SC injection of TNX-4800 2 subjects: placebo (2217LS) when administered to 1 12 10 subjects: 2217LS 0.5 SC healthy subjects Secondary Objective: 2 subjects: placeb
Slide 17: TNX-4800 Phase 1 Study Results
TNX-4800 Phase 1 Study Results • No significant clinical or laboratory safety signals • The mean exposure, based on AUC-inf and Cmax for Cohort 4 (10mg/kg), was less than 17% of the highest exposures in the rat toxicology study • Serum TNX-4800 (2217LS) was measurable at the earliest sampling time o
Slide 18: Observed Phase 1 Pharmacokinetics
18 Observed Phase 1 Pharmacokinetics 120 days 180 days 10 μg/ml – in vitro MEC tick feeding 5 μg/ml – in vitro ~10x EC50 Each point represents a mean for the cohort at that timepoint and dose 18 UMass Chan Medical School
Slide 19: Next Steps: Phase 2 Field Study
Next Steps: Phase 2 Field Study • Licensed to Tonix Pharmaceuticals - 2025 now TNX-4800 • Proposed Phase 2 field study – 2027 pending FDA clearance 19 UMass Chan Medical School
Slide 20: A Long-Acting Monoclonal Antibody for Seasonal Prevention of Lyme Disease
A Long-Acting Monoclonal Antibody for Seasonal Prevention of Lyme Disease Mark S. Klempner, MD Professor of Medicine UMass Chan Medical School
Slide 21: Supplemental Slides
Supplemental Slides 21 UMass Chan Medical School
Slide 22: Minimum Effective Concentration of TNX-4800 is <10μg/ml in the Infected Tick
Minimum Effective Concentration of TNX-4800 is < 10μg/ml in the Infected Tick The monoclonal OspA antibody TNX-4800 (2217LS) inhibits tick-to-blood transmission of B. burgdorferi B31-5A4 in a dose-dependent manner in an artificial membrane feeding system. Blood 5dpf * * * (copies/100ng DNA) 10 6 * B
Slide 23: Variability of serum concentrations at sampling time points among subjects in each dosing cohort
Variability of serum concentrations at sampling time points among subjects in each dosing cohort 23 UMass Chan Medical School
Slide 24: Pharmacokinetic Parameters
Pharmacokinetic Parameters Pharmacokinetic 0.5 mg/kg 2217LS 1.5 mg/kg 2217LS 5 mg/kg 2217LS 10 mg/kg 2217LS Parameters AUC0-t (ng*hr/mL) 6271000 (26.0) [n=10] 20610000 (23.7) [n=8] 79760000 (36.5) [n=8] 165500000 (26.0) [n=8] AUC0-inf (ng*hr/mL) 6812000 (25.3) [n=10] 21490000 (23.5) [n=8] 82070000 (
Slide 25: CDC Study Makes a Strong case for Antibody vs Vaccine
CDC Study Makes a Strong case for Antibody vs Vaccine Lyme Disease Vaccine Intentions Among Parents of 5–18 Year Olds in U.S. States with High or Emerging Incidence (CDC-sponsored study presented at 2023 Pediatric Academic Societies (PAS) Conference) Methods Outcome • Conducted online survey (N=1,35
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