Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Global Lyme Alliance (May 2026)

31 slides from Tonix Pharmaceuticals's conference presentation, May 15, 2026

  1. Slide 1: TNX-4800: A Long-Acting, Bactericidal, Human Monoclonal Antibody to Prevent Lyme Disease in the U.S.

    TNX-4800: A Long-Acting, Bactericidal, Human Monoclonal Antibody to Prevent Lyme Disease in the U.S. Zeil Rosenberg MD, MPH Executive Vice President, Medical Tonix Pharmaceuticals Global Lyme Alliance PO6143 May 15, 2026 1660 © 2026 Tonix Pharmaceuticals Holding Corp.

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

    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 words such as “anticipate,” “believe,” “forecast,” “e

  3. Slide 3: Tonix Pharmaceuticals – Transforming Medicine for the Future

    Tonix Pharmaceuticals – Transforming Medicine for the Future 3 FDA Approved Products Therapeutic Areas of Focus: TNXP • CNS • ~$185.5 M cash as of • Infectious Disease March 31, 2026 • Immunology • No debt • Rare Disease Partnerships with major Universities Fully Integrated and the U.S. Federal Gove

  4. Slide 4: First FDA-Approved Treatment for Fibromyalgia in Over 15 Years

    First FDA-Approved Treatment for Fibromyalgia in Over 15 Years First-in-class, First-line Medicine Unique, Sublingual, Proprietary Formulation Supports: Efficacy, Absorption, and Tolerability Current Treatments TONMYA Limited approved and Distinct mechanism of effective options action versus current

  5. Slide 5: Overlap of Fibromyalgia and Chronic Lyme Disease

    Overlap of Fibromyalgia and Chronic Lyme Disease Fibromyalgia is a Fibromyalgia diagnosable condition in: ✓ Long COVID ✓ Chronic Lyme disease ✓ Other Infection Associated Chronic Chronic Illness (IACI) Lyme Long COVID Disease 5 © 2026 Tonix Pharmaceuticals Holding Corp.

  6. Slide 6: Addressing the Lyme Disease Spectrum

    Addressing the Lyme Disease Spectrum Risk Period: Living, working or traveling Borrelia Acute Lyme Chronic Lyme to Lyme-endemic areas Infection Disease Disease Potential to Treatment for prevent Fibromyalgia transmission associated with with TNX-4800 chronic Lyme H Dinerman, Steer AC 1992 6 doi: 10.

  7. Slide 7: Introducing TNX-4800

    Introducing TNX-4800 TNX-48001,2 is a human anti-OspA monoclonal antibody (HuMAb) with engineered Fc domain for extended half-life, licensed from UMass Chan Medical School in 2025 (Formerly 2217LS) Expected Mechanism of Action Transmission Two-dosecRegimen c Tick Attaches AntibodycIngested c OspA Bi

  8. Slide 8: Clinical and Market Acceptance of Monoclonal Antibody Preventive Treatments

    Clinical and Market Acceptance of Monoclonal Antibody Preventive Treatments Monoclonal antibody prophylaxis has been approved for respiratory syncytial virus (RSV) and COVID-19, including ENFLONSIA (clesrovimab),1 BEYFORTUS®),(nirsevimab) 2 PEMGARDA (pemivibart)3 1. Enflonsia. Prescribing informatio

  9. Slide 9: TNX-4800 Long-acting anti-OspA Monoclonal Antibody Design

    TNX-4800 Long-acting anti-OspA Monoclonal Antibody Design Engineered Fc domain (LS) binding to FcRn for an extended half-life that targets OspA of Borrelia burgdorferi1,2 1. Schiller ZA, et al. J Clin Invest. 2021;131(11):e144843. 9 2. Wang Y, et al. J Infect Dis. 2016;214(2):205-211. © 2026 Tonix P

  10. Slide 10: TNX-4800 is Not a Vaccine

    TNX-4800 is Not a Vaccine Limitations of OspA vaccines • Protection depends on titer of OspA at the moment the deer tick sucks blood • High-titer vaccine responses require onerous immunization schedule • Little or no “memory” response on Borrelia exposure • OspA-expressing Borrelia is sequestered in

  11. Slide 11: Prophylactic Monoclonal Antibody (mAb) Characteristics

    Prophylactic Monoclonal Antibody (mAb) Characteristics Potential attributes of anti-OspA mAb TNX-4800 • Nearly-immediate protection (within 2 days) • Not reliant on patient’s immune status • Replaces heterogeneous polyclonal response of vaccine with homogeneous monoclonal agent with defined properti

  12. Slide 12: Analysis of Minimum Effective Concentration (MEC) – Method #1 – in vivo Primate Challenge Model

    Analysis of Minimum Effective Concentration (MEC) – Method # 1 – in vivo Primate Challenge Model Three Models for MEC determination used: • in vitro borreliacidal activity • in vitro tick feeding assays • in vivo NHP challenge 12 © 2026 Tonix Pharmaceuticals Holding Corp.

  13. Slide 13: Nonhuman Primate Challenge Model: Protocol and Protection by Dosage Level

    Nonhuman Primate Challenge Model: Protocol and Protection by Dosage Level Study Design1: Jacket Tick Culture Acclimation Challenge Tissue Biopsy Observations Day -7 01 6 14 21 28 45 63 HuMAb Serum Injection Collection • Dose escalation study: 4 cohorts, 1 irrelevant IgG control • 4 to 6 animals per

  14. Slide 14: Analysis of Minimum Effective Concentration (MEC) – Three Methods

    Analysis of Minimum Effective Concentration (MEC) –Three Methods • Serum ~5 μg/mL – in vitro bactericidal activity (not shown) • TNX-4800 showed EC50 ≈ 0.56 μg/mL in vitro1 • MEC ~ 10X EC502 • Serum <10 μg/mL – in vitro tick feeding experiment (not shown) • TNX-4800 showed killing ≥ 10 μg/ml3 • Seru

  15. Slide 15: Phase 1 Clinical Trial

    PHASE 1 CLINICAL TRIAL © 2026 Tonix Pharmaceuticals Holding Corp.

  16. Slide 16: Human Phase 1 Study: Safety, Tolerability and Immunogenicity: Design

    Human Phase 1 Study: Safety, Tolerability and Immunogenicity: Design • First-in-human, randomized, double-blind, sequential dose-escalation study (N=44) • Healthy male and female volunteers aged 19 to 65 years, serum negative for anti–B. burgdorferi antibodies, by an FDA-approved modified 2-tier ELI

  17. Slide 17: TNX-4800 Phase 1 Study objectives and population

    TNX-4800 Phase 1 Study objectives and population Primary Objective: • Evaluate safety and tolerability of a SC injection of TNX-4800 when administered to healthy volunteers Secondary Objective: • Evaluate pharmacokinetics of a SC dose of TNX-4800 when administered to healthy volunteers Study Populat

  18. Slide 18: Phase 1 Safety Summary

    Phase 1 Safety Summary • 1 serious adverse event (SAE); in placebo group 1 • Total of 61 TEAEs reported by 21/34 (62%) participants compares to 3/10 (30%) in placebo • Large majority of drug related Treatment-Emergent Adverse Events (TEAEs) were mild (82%); remainder moderate (18%) • Transient ADAs

  19. Slide 19: Related TEAE Summary

    Related TEAE Summary1 Adverse Event Severity Grade # Subjects Dysgeusia 1 1 Feeling hot/ flush 1 2 Injection site reaction* 1 7 Injection site reaction 2 1 Palpitations 1 1 Paresthesia 1 1 Severity Grading: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life Threatening *Injection site

  20. Slide 20: Observed Phase 1 Pharmacokinetics

    Observed Phase 1 Pharmacokinetics 56 days 21 μg/ml – ceiling for MEC from in vivo Primate challenge Each point represents a mean for the cohort at the specified timepoint and dose. 20 © 2026 Tonix Pharmaceuticals Holding Corp.

  21. Slide 21: Phase 1 Summary

    Phase 1 Summary • No significant clinical or laboratory signals were identified at any dose level. • Drug exposure increased by approximately 25 times for a 20-times increase in dose, indicating dose proportional PK. • Serum TNX-4800 was measurable at two days, indicating rapid systemic absorption.

  22. Slide 22: Future Plans

    FUTURE PLANS © 2026 Tonix Pharmaceuticals Holding Corp.

  23. Slide 23: Design of Planned Adaptive Phase 2 Field Study in 2027

    Design of Planned Adaptive Phase 2 Field Study* in 2027 Dose 1 Dose 2 Tick Season Day 1 Day 56 6 Months Surveillance Study participants randomized 1:1 to receive TNX-4800 or placebo *Pending FDA agreement. 23 © 2026 Tonix Pharmaceuticals Holding Corp.

  24. Slide 24: Preliminary Modeling: Mean Predictions, 350mg SC on Day 1 and Day 56

    Mean Predictions: 350mg SC on Day 1 and 56 Days Preliminary Modeling TNX-4800 (adjusted) 100000 Serum TNX-4800 (μg/ml) PK with 2nd Dose Concentration [ng/mL] 20 μg/ml 15 μg/ml 10000 10 μg/ml PK with 1st Dose 1000 0 50 100 150 200 250 300 350 400 Time [days] Simulated Mean MEC1 MEC2 MEC3 Minimum Effe

  25. Slide 25: Planned Adaptive Phase 2 Field Trial 2027

    Planned Adaptive Phase 2 Field Trial 2027 Adaptive, randomized, double-blind, placebo-controlled study • Objective: • To evaluate the efficacy and safety of TNX-4800 in preventing the first occurrence of confirmed Lyme disease during the primary efficacy surveillance period (Day 3 through Month 6 fo

  26. Slide 26: Addressing the Significant Public Health Challenge of Lyme Disease in the U.S.

    Addressing the Significant Public Health Challenge of Lyme Disease in the U.S. ✓ Phase 1 study complete, showing favorable safety, tolerability, immunogenicity, and pharmacokinetics ✓ Phase 2 adaptive field study planning and GMP manufacturing underway for 1H 2027 TNX-4800 Upcoming Milestones 2026 E

  27. Slide 27: Development of TNX-4800 (formerly 2217 LS)

    Development of TNX-4800 (formerly 2217 LS) ACKNOWLEDGEMENTS Inventors: UMass Chan School of Medicine • Mark S. Klempner, MD • Yang Wang MD, PhD • William D. Thomas MD • Naomi K. Boatright PhD Support (to U Mass Chan): • National Center for Advancing Translational Sciences (NCATS), NIH • DARPA • DOD

  28. Slide 28: Tonix Acknowledgements

    Tonix Acknowledgements Tonix Pharmaceuticals: Advisors/Consultants​: Seth Lederman MD Mark Klempner, MD Greg Sullivan MD Yang Wang, MD PhD Siobhan Fogarty MS Grace Chen-Phillips MD Sina Bavari PhD Phil Krause MD Christopher Cooper PhD Cathy Panozzo PhD Hadi Falahatpisheh PhD Bernd Meibohm, PhD Nita

  29. Slide 29: Thank You

    THANK YOU © 2026 Tonix Pharmaceuticals Holding Corp.

  30. Slide 30: TONMYA Important Safety Information (ISI)

    TONMYA Important Safety Information (ISI) Indication • Tonmya is indicated for the treatment of fibromyalgia in adults. Contraindications: • Hypersensitivity to cyclobenzaprine or any inactive ingredient in cyclobenzaprine HCl sublingual tablets • Concomitant use of monoamine oxidase inhibitors or w

  31. Slide 31: TONMYA ISI (Continued)

    TONMYA ISI (Continued) Drug Interactions: • Monoamine oxidase inhibitors: Life-threatening interactions may occur • Other serotonergic drugs: Serotonin syndrome has been reported • CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced • Tramadol:

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