Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — BIO International Convention 2025

29 slides from Tonix Pharmaceuticals's conference presentation, Jun 16, 2025

  1. Slide 1: BIO International

    BIO International June 16, 2025 NASDAQ: TNXP PO6081 June 16, 2025 (Doc 1598) © 2025 Tonix Pharmaceuticals Holding Corp.

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

    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 Litigation Reform Act of 1995. These statements may be i

  3. Slide 3: Our Mission and Vision

    Our Mission and Committed to improving population health by inventing, developing Vision and marketing innovative therapies and vaccines, through broad in-house capabilities and creative collaborations, to address important unmet needs in CNS, immunology / immuno- oncology, and infectious disease ©

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

    Fully-Integrated Biotech: Key Commercial, Clinical & Preclinical Programs Molecule* Indication Phase 1 Phase 2 Phase 3 NDA Submission Approved Potential Fibromyalgia Product TNX-102 SL Granted FDA Fast Track PDUFA** goal date of August 15, 2025 Launch Cyclobenzaprine Designation Q4 2025 CNS Portfoli

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

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

  6. Slide 6: Fibromyalgia (FM) is a Large, Underserved and Dissatisfied population

    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 >10 million U.S. adults are affected Patie

  7. Slide 7: Bedtime Oral Cyclobenzaprine Fails to Provide Durable Activity on Pain in Fibromyalgia

    Bedtime Oral Cyclobenzaprine Fails to Provide Durable (>1 Month) Activity on Pain in Fibromyalgia CNS PORTFOLIO Oral Cyclobenzaprine1 Visual analog scale score (0-100) placebo cyclobenzaprine * Months *P<0.05 vs placebo-treated group. Dosing • Cyclobenzaprine 20 mg at bedtime Study • Double-blind, r

  8. Slide 8: TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) 5.6 mg

    TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) 5.6 mg* Potential to be the first FDA-approved therapy for fibromyalgia in over 15 years CNS PORTFOLIO A unique, sublingual, proprietary formulation of cyclobenzaprine (CBP) designed to optimize absorption and delivery • Two pivotal studies demonst

  9. Slide 9: Bedtime TNX-102 SL Treatment Results in Durable Activity on Pain in RESILIENT Study

    Bedtime TNX-102 SL Treatment Results in Durable (~3 Month) Activity on Pain in Fibromyalgia in RESILIENT Study CNS PORTFOLIO TNX-102 SL1 LS mean NRS pain score (0-10) placebo * * TNX-102SL * Months *P<0.001 vs placebo MMRM with MI. Dosing • TNX-102 SL 5.6 mg at bedtime ‒ First two weeks, TNX-102 SL

  10. Slide 10: Oral Cyclobenzaprine Undergoes First-pass Metabolism, Increasing norCBP

    Oral Cyclobenzaprine Undergoes First-pass Metabolism, Leading to Increased Concentrations of norCBP Relative to CBP Over Time CNS PORTFOLIO CBP undergoes “first-pass” hepatic metabolism and is CBP administered as a ~50% converted to the CBP and norCBP enter swallowed oral dose persistent active meta

  11. Slide 11: TNX-102 SL Bypasses First-pass Metabolism, Leading to Faster Absorption and Reduced norCBP

    TNX-102 SL Bypasses First-pass Metabolism, Leading to Faster Absorption and Reduced norCBP CNS PORTFOLIO The sublingual tablet rapidly disintegrates, dissolves, and releases solubilized CBP into the saliva adjacent to the mucosal membrane TNX-102 SL is CBP enters the brain administered sublingually

  12. Slide 12: Poor Sleep and Pain have Bidirectional Reinforcing Effects

    Poor Sleep and Pain have Bidirectional Reinforcing Effects1 CNS PORTFOLIO • Harvey Moldofsky – recognition of unrefreshing/non-restorative sleep in fibromyalgia Fatigue PAIN BAD Brain Fog SLEEP • Poor sleep and pain form a vicious cycle in driving fibromyalgia decompensation ̶ Can’t sleep → worse pa

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

    RESILIENT Primary Outcome Measure Reduction in Widespread Pain CNS PORTFOLIO Weekly Average of Daily Diary NRS Ratings of Average Pain Over Prior 24 Hours 0 Placebo (N=225) TNX-102 SL (N=231) -0.2 LS Mean (SE) Change in NRS Pain -0.4 Dosing -0.6 • TNX-102 SL 5.6 mg at bedtime -0.8 * ‒ First two week

  14. Slide 14: RESILIENT Summary of Activity

    RESILIENT Summary of Activity CNS PORTFOLIO 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 = 0.0000001 • Global (PGIC) p-value = 0.00013 • Symptoms (FIQ

  15. Slide 15: RESILIENT Tolerability

    RESILIENT Tolerability CNS PORTFOLIO Treatment-Emergent Adverse Events (TEAEs) at Rate of ≥ 3% in Either Treatment Group System Organ Class TNX-102 SL Placebo Total* Preferred Term N=231 N=226 N=457 Systemic Adverse Events COVID-19 10 (4.3%) 7 (3.1%) 17 (3.7%) Somnolence 7 (3.0%) 3 (1.3%) 10 (2.2%)

  16. Slide 16: Current FDA-Approved Fibromyalgia Drugs

    Current FDA-Approved Fibromyalgia Drugs1 CNS PORTFOLIO No current FDA-Approved FM drug addresses pain, poor sleep and fatigue • Improvement in fibromyalgia pain was primary endpoint for approval for currently approved FM drugs • Tolerability issues may limit long term use for many patients Drug Preg

  17. Slide 17: RESILIENT Summary of Activity and Tolerability

    RESILIENT Summary of Activity and Tolerability CNS PORTFOLIO 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 root of the problem • Potential for a broad-spectr

  18. Slide 18: If Approved, TNX-102 SL Will Join Tonix Medicines' Two Existing Proprietary CNS Drugs

    If Approved, TNX-102 SL Will Join Tonix Medicine’s Two Existing Proprietary CNS drugs: Non-oral Formulations of Sumatriptan Tonix Medicines Commercial Subsidiary: Complete Commercialized Capabilities & Infrastructure • Trade, Managed Care & Government contracting • Team of professionals including Sa

  19. Slide 19: Tonix Medicines' Commercial Team has ~100 Years of Commercial and Launch Expertise

    Tonix Medicines’ Commercial Team has ~100 Years of Commercial and Launch Expertise CNS PORTFOLIO Thomas Englese EVP Commercial/ President Bradley Raudabaugh VP Mktg & Commercial Ops Gary Ainsworth VP Market Access Scott Szymanski VP Sales 19 © 2025 Tonix Pharmaceuticals Holding Corp.

  20. Slide 20: Concentration of High Prescribing HCPs in Fibromyalgia Allows Targeted Model

    Concentration of High Prescribing HCPs in Fibromyalgia Allows Tonix Medicines to Sell via Targeted Model and Omni Channel Marketing CNS PORTFOLIO Of the ~470k prescribing HCPS, ~6% are responsible for writing ~70% of all FM prescriptions & diagnosing ~70% of all patients Decile Number of HCPS Avg An

  21. Slide 21: Omni Channel Marketing and Messaging Campaign Planned

    Omni Channel Marketing and Messaging Campaign Planned to Maximize Reach Within the Retail and Specialty Channels CNS PORTFOLIO BRANDED ECOSYSTEMS Paid KOL/DOL Paid Search Search Programming Website Patient Testimonials Website IVA Digital Media Social Ads Social Digital HCPS Ads Social Ads Welcome P

  22. Slide 22: Tonix's scientific expertise validated by government and academic collaborations

    TNX-102 SL: ACUTE STRESS DISORDER Tonix’s scientific expertise validated by numerous mutually beneficial TNX-2900: PRADER-WILLI SYNDROME government and academic collaborations TNX-1800: COVID-19 VACCINE • Reduces internal spend • Increases number of trials TNX-4200: BROAD-SPECTRUM ANTIVIRAL • Potent

  23. Slide 23: TNX-102 SL Milestones: Recently Completed and Upcoming

    TNX-102 SL Milestones: Recently Completed and Upcoming Q4 2025 Target Aug 15, Commercial 2025 Launch for TNX- Q2 2025 PDUFA date 102 SL Initiated TNX-102 SL Enrollment in Q4 2024 Ph 2 TNX-102 Submitted NDA SL Trial in to FDA for Acute Stress TNX-102 SL Disorder (ASD) / Acute Stress Q3 2024 Reaction

  24. Slide 24: Thank You

    Thank You © 2025 Tonix Pharmaceuticals Holding Corp.

  25. Slide 25: Zembrace Important Safety Information (1 of 2)

    Zembrace® Important Safety Information (1 of 2) CNS PORTFOLIO 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 a heart attack: • Discomfort in the center of

  26. Slide 26: Zembrace Important Safety Information (2 of 2)

    Zembrace® Important Safety Information (2 of 2) CNS PORTFOLIO 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, nausea or vomiting, constipation or diarrhea, bloody diarrh

  27. Slide 27: Tosymra Important Safety Information (1 of 2)

    Tosymra® Important Safety Information (1 of 2) CNS PORTFOLIO 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 attack: • Discomfort in the center of your chest

  28. Slide 28: Tosymra Important Safety Information (2 of 2)

    Tosymra® Important Safety Information (2 of 2) 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

  29. Slide 29: TNX-102 SL: Patents and Patent Applications

    TNX-102 SL: Patents and Patent Applications CNS PORTFOLIO • 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 November 2034) ̶ A composition of a cyclobenzaprin

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