Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (July 2025)

39 slides from Tonix Pharmaceuticals's investor presentation, Jul 16, 2025

  1. Slide 1: Corporate Presentation July 2025

    © 2025 Tonix Pharmaceuticals Holding Corp. Corporate Presentation July 2025 NASDAQ: TNXP PO6091 July 2025 (Doc 1608 )

  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: Our Mission

    © 2025 Tonix Pharmaceuticals Holding Corp. OUR MISSION Committed to improving health by inventing, developing and delivering impactful solutions, through robust in - house capabilities and creative collaborations, to address important unmet needs in nociplastic pain, immunology / immuno - oncology,

  4. Slide 4: Fully-Integrated Biotech: Key Commercial, Clinical & Preclinical Programs

    © 2025 Tonix Pharmaceuticals Holding Corp. Approved NDA Submission Phase 3 Phase 2 Phase 1 Indication Molecule * Fibromyalgia Granted FDA Fast Track Designation TNX - 102 SL Cyclobenzaprine HCl Sublingual Tablets CNS Portfolio Acute Stress Disorder Treatment of acute migraine Tosymra® Treatment of a

  5. Slide 5: CNS Portfolio: Key Products & Candidates

    © 2025 Tonix Pharmaceuticals Holding Corp. CNS Portfolio: Key Products & Candidates 5

  6. Slide 6: Fibromyalgia is a Large, Underserved and Dissatisfied Population

    © 2025 Tonix Pharmaceuticals Holding Corp. Fibromyalgia (FM) is a Large, Underserved and Dissatisfied population chronic pain disorder resulting from amplified sensory and pain signaling within the CNS - a syndrome comprised of the symptoms: chronic widespread pain, nonrestorative sleep, and fatigue

  7. Slide 7: Over 75% of Fibromyalgia Prescriptions are Off-Label

    © 2025 Tonix Pharmaceuticals Holding Corp. Within 18 Months After Fibromyalgia Diagnosis Over 75% of Prescriptions are Off - Label and ~50% are for Off - Label Opioids CBP, cyclobenzaprine; NSAID, nonsteroidal anti - inflammatory drug; SNRI, serotonin norepinephrine reuptake inhibitor; TCA, tricyc l

  8. Slide 8: Poor Sleep and Pain have Bidirectional Reinforcing Effects

    8 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Poor Sleep and Pain have Bidirectional 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 - restorative

  9. Slide 9: Bedtime Oral Cyclobenzaprine Fails to Provide Durable Pain Relief

    9 © 2025 Tonix Pharmaceuticals Holding Corp. CONFIDENTIAL. INTERNAL USE ONLY. PROPERTY OF TONIX MEDICINES, INC. Bedtime Oral Cyclobenzaprine Fails to Provide Durable (>1 Month) Activity on Pain Relief in Fibromyalgia 1 CBP, cyclobenzaprine. Figure modified and redrawn from Carette S, et al. Arthriti

  10. Slide 10: TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets)

    10 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL (Cyclobenzaprine HCl Sublingual Tablets) 5.6 mg 1 Potential to be the first FDA - approved therapy for fibromyalgia in over 15 years A unique, sublingual, proprietary formulation of cyclobenzaprine (CBP) designed to optimize ab

  11. Slide 11: Oral CBP Undergoes First-Pass Metabolism

    11 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CBP and norCBP enter the brain Oral CBP Undergoes First - pass Metabolism, Leading to Increased Concentrations of norCBP Relative to CBP Over Time tongue CBP administered as a swallowed oral dose CBP undergoes “first - pass” hepatic metabol

  12. Slide 12: TNX-102 SL Bypasses First-Pass Metabolism

    12 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CBP enters the brain directly via the circulatory system TNX - 102 SL Bypasses First - pass Metabolism, Leading to Faster Absorption and Reduced norCBP tongue TNX - 102 SL is administered sublingually The sublingual tablet rapidly disintegr

  13. Slide 13: RESILIENT Primary Outcome Measure: Reduction in Widespread Pain

    13 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT Primary Outcome Measure 1 Reduction in Widespread Pain -2.2 -2 -1.8 -1.6 -1.4 -1.2 -1 -0.8 -0.6 -0.4 -0.2 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 LS Mean (SE) Change in NRS Pain Score Week of Study Placebo (N=225) TNX-102 SL (N=231)

  14. Slide 14: RESILIENT Summary of Activity

    14 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT Summary of Activity Primary Pain, and Key Secondary Endpoints • Pain (primary endpoint, daily pain diary): p - value = 0.00005 • Fatigue (PROMIS fatigue): p - value = 0.00009 • Sleep (PROMIS sleep disturbance): p - value = 0.00000

  15. Slide 15: RESILIENT Tolerability

    15 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT Tolerability Total* N=457 Placebo N=226 TNX - 102 SL N=231 System Organ Class Preferred Term Systemic Adverse Events 17 (3.7%) 7 (3.1%) 10 (4.3%) COVID - 19 10 (2.2%) 3 (1.3%) 7 (3.0%) Somnolence 11 (2.4%) 4 (1.8%) 7 (3.0%) Headac

  16. Slide 16: RESILIENT Summary of Activity and Tolerability

    16 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT Summary of Activity and Tolerability Activity: TNX - 102 SL has “broad spectrum” or “syndromal” activity • Broad spectrum : activity across several symptoms • Syndromal : improves the syndrome (most of the symptoms) closer to the

  17. Slide 17: Current FDA-Approved Fibromyalgia Drugs

    17 © 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 ® ); and Milnacipran (Savella ® ) 2 Leung MTY, et al . JAMA Netw Open . 2024

  18. Slide 18: TNX-102 SL: Patents and Patent Applications

    18 © 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

  19. Slide 19: Tonix's Two Existing Proprietary CNS Drugs: Tosymra and Zembrace

    © 2025 Tonix Pharmaceuticals Holding Corp. If Approved, TNX - 102 SL will Join Tonix Medicine’s Two Existing Proprietary CNS Drugs: Both are Non - Oral Formulations of Sumatriptan • Tosymra ® and Zembrace ® are each indicated for the tr eatment of acute migraine with or without aura in adults • Suma

  20. Slide 20: Commercial Team has ~100 Years of Commercial and Launch Expertise

    20 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tonix Medicines’ Commercial Team has ~100 Years of Commercial and Launch Expertise Thomas Englese EVP Commercial/ President Scott Szymanski VP Sales Bradley Raudabaugh VP Mktg & Commercial Ops Gary Ainsworth VP Market Access

  21. Slide 21: Concentration of High Prescribing HCPs Allows Targeted Model

    21 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Concentration of High Prescribing HCPs in Fibromyalgia Allows Tonix Medicines to Sell via Targeted Model and Omni Channel Marketing Of the ~470k prescribing HCPS, ~6% are responsible for writing ~70% of all FM prescriptions & diagnosing ~70

  22. Slide 22: Patients and HCPs are Challenged by the Fibromyalgia Journey

    © 2025 Tonix Pharmaceuticals Holding Corp. Both Patients and HCPs are Challenged by the Fibromyalgia Journey 1 FRUSTRATED Motivate patients to request TNX - 102 SL as a treatment that treats a bigger picture of their fibromyalgia. Drive HCPs to see TNX - 102 SL as a potential new product that finall

  23. Slide 23: Omni Channel Marketing and Messaging Campaign

    23 © 2025 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Social Ads HCPS PATIENTS Digital Media Website Paid Search Rep Leave Behind HCP HOE Emails Digital Media Website Paid Search Email CRM Program Social Ads Patient Support Program Patient Testimonials Influencer Program Welcome Kit KOL/DOL Pr

  24. Slide 24: Immunology & Immuno-oncology Portfolio: Key Candidates

    © 2025 Tonix Pharmaceuticals Holding Corp. Immunology & Immuno - oncology Portfolio: Key Candidates 24

  25. Slide 25: TNX-1500 Third Generation Anti-CD40L Antibody

    TNX - 1500 1 Next (Third) Generation ߙ - CD40 Ligand (CD40L) Antibody The CD40 - CD40L pathway is a pivotal immune system modulator and a well - established and promising treatment target First Generation: Development halted due to thromboembolic (TE) complications — blood clots — traced to Fc gamma

  26. Slide 26: TNX-1500 Phase 1 Topline Results and Conclusions

    26 © 2025 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 Phase 1 Topline Results and Conclusions Phase 1: single ascending dose study in healthy participants to evaluate safety and pharmacokinetics/pharmacodynamics (PK/PD) • At total of 26 participants were enrolled in three coh

  27. Slide 27: TNX-1700 Gastric and Colorectal Cancers

    TNX - 1700 1 Gastric and Colorectal Cancers Recombinant Trefoil Factor 2 (hTFF2) Fusion Protein Mechanism of Action : suppresses myeloid - derived suppressor cells and activates anti - cancer CD8+ T cells Potential synergies with anti - PD - 1 or antil - PD - L1 monoclonal antibodies (mAbs) Licensed

  28. Slide 28: TNX-1700 Recent Publication in Cancer Cell

    28 © 2025 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1700 – Recent Publication in Cancer Cell Combination treatment of mTNX - 1700 (mTFF2 - MSA fusion protein) with anti - PD1 antibody was associated with increased survival and decreased metastases in animal models of gastric can

  29. Slide 29: Infectious Disease Portfolio: Key Candidates

    © 2025 Tonix Pharmaceuticals Holding Corp. Infectious Disease Portfolio: Key Candidates 29

  30. Slide 30: Tonix Research and Development Center

    30 © 2025 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Tonix Research and Development Center (RDC) • Supports expanding infectious disease pipeline by accelerating internal discovery and development of vaccines and antiviral drugs • Located in Frederick, MD (close to Fort Detrick

  31. Slide 31: Recombinant Pox Vaccine Platform Using Live Virus Technology

    © 2025 Tonix Pharmaceuticals Holding Corp. TNX - 801 1 Recombinant Pox Vaccine (RPV) Platform Using Live Virus Technology Economical to manufacture at scale: l ow dose because replication amplifies dose in vivo single administration Standard refrigeration for shipping and storage: believed to be sta

  32. Slide 32: TNX-4200 Broad-spectrum Host-directed Therapeutics

    © 2025 Tonix Pharmaceuticals Holding Corp. TNX - 4200 1 Broad - spectrum Host - directed Therapeutics: CD45 Inhibitor as Antiviral Department of Defense Contract : awarded Tonix a $34M contract over five years to advance development of TNX - 4200 for medical countermeasures Broad antiviral applicati

  33. Slide 33: Government and Academic Collaborations

    © 2025 Tonix Pharmaceuticals Holding Corp. Tonix’s scientific expertise validated by numerous mutually beneficial government and academic collaborations • Reduces internal spend • Increases number of trials • Potentially speeds time to market • Grants, contracts, cost - sharing or “in - kind” arrang

  34. Slide 34: Milestones: Recently Completed and Upcoming

    © 2025 Tonix Pharmaceuticals Holding Corp. Milestones: recently completed and upcoming Q3 2024 FDA Fast Track Designation granted Q3 2024 Submitted NDA to FDA for TNX - 102 SL Q1 2025 Topline results from Ph 1 PK/PD TNX - 1500 study Aug 15, 2025 PDUFA date TNX - 102 SL Q4 2025 Target Commercial Laun

  35. Slide 35: Thank You

    © 2025 Tonix Pharmaceuticals Holding Corp. THANK YOU 35

  36. Slide 36: Zembrace Important Safety Information (1 of 2)

    36 © 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 of

  37. Slide 37: Zembrace Important Safety Information (2 of 2)

    37 © 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 vo

  38. Slide 38: Tosymra Important Safety Information (1 of 2)

    38 © 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

  39. Slide 39: Tosymra Important Safety Information (2 of 2)

    39 © 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,

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