Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — BIO CEO & Investor Conference 2025

38 slides from Tonix Pharmaceuticals's conference presentation, Feb 10, 2025

  1. Slide 1: BIO CEO Conference

    BIO CEO Conference Seth Lederman, CEO February 10, 2025 NASDAQ: TNXP PO6042 Feb 10, 2025 (Doc 1558) © 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: Key Clinical Programs

    Key Clinical Programs NDA Molecule* Indication Phase 1 Phase 2 Phase 3 Submission Fibromyalgia Granted FDA Fast Track PDUFA** goal date of August 15, 2025 TNX-102 SL Designation Cyclobenzaprine HCl Sublingual Tablets Phase 2 Study*** Start Acute Stress Disorder Expected 1Q’25 TNX-1300 Cocaine Intoxi

  4. Slide 4: CNS-Focused Fully-Integrated Biopharma with Preclinical, Clinical and Commercial Stage Products

    CNS-Focused Fully-Integrated Biopharma with Preclinical, Clinical and Commercial Stage Products TNX-102 SL1 for Fibromyalgia: FDA Decision on marketing authorization expected August 15, 2025 • Granted FDA Fast Track Designation • Two Phase 3 trials completed with statistical significance on primary

  5. Slide 5: TNX-102 SL

    TNX-102 SL* (Cyclobenzaprine HCl Sublingual Tablets) 5.6 mg A unique, sublingual formulation of cyclobenzaprine (CBP) designed to optimize absorption and delivery • Non-opioid analgesic – Tertiary Amine Tricyclic (TAT) • Rapid drug exposure following once-nightly sublingual administration • Reductio

  6. Slide 6: TNX-102 SL Fibromyalgia Regulatory Status

    TNX-102 SL (5.6 mg) Fibromyalgia Regulatory Status CNS PORTFOLIO • NDA can be filed without abuse potential assessment studies ‒ April 2017 • Granted FDA Fast Track Designation ‒ July 2024 • Submitted NDA to FDA ‒ October 2024 • NDA assigned a PDUFA goal date of August 15, 20251 ‒ December 2024 Next

  7. Slide 7: TNX-102 SL Fibromyalgia Pivotal Clinical Trial Results

    TNX-102 SL (5.6 mg) Fibromyalgia Pivotal Clinical Trial Results CNS PORTFOLIO • Activity • First pivotal Phase 3 study (RELIEF) reported – December 20201 ‒ Statistically significant reduction in daily pain compared to placebo (p = 0.010) • Second Phase 3 study (RALLY) missed primary endpoint – July

  8. Slide 8: TNX-102 SL: Sublingual Formulation Designed for Long-Term Daily Administration at Bedtime

    TNX-102 SL: Sublingual Formulation is Designed for Long-Term Daily Administration at Bedtime and Transmucosal Absorption CNS PORTFOLIO • TNX-102 SL: Proprietary sublingual formulation of cyclobenzaprine (CBP) with transmucosal absorption ‒ Innovation by design with patent-protected eutectic formulat

  9. Slide 9: ~50% of Oral CBP is Converted to norCBP by the Liver

    ~50% of Oral CBP is Converted to norCBP by the Liver norCBP has “Flat” PK and Accumulates with Chronic Dosing CNS PORTFOLIO Cyclobenzaprine (CBP) norCyclobenzaprine (norCBP) “First pass” hepatic metabolism H3C CH3 H3C N Tertiary N Secondary Amine tail demethylation Amine tail CH3 H Dynamic pharmacok

  10. Slide 10: Oral CBP Undergoes First-Pass Metabolism – Tongue DOWN

    Oral CBP Undergoes First-Pass Metabolism – “Tongue DOWN” Accumulation of persistent metabolite 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 metabolite the brain norCyclobenzap

  11. Slide 11: TNX-102 SL: Transmucosal CBP – Tongue UP

    TNX-102 SL: Transmucosal CBP – “Tongue UP” Differentiated by dynamic ratios of parent and metabolite 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 sub

  12. Slide 12: TNX-102 SL: Multi-Dose PK Differentiation from Simulated Oral CBP-IR

    TNX-102 SL: Multi-Dose PK Differentiation from Simulated Oral CBP-IR CNS PORTFOLIO Steady State PK (after 20 days dosing) Day 20 TNX-102 SL 5.6 mg v. Simulated Oral IR 10 mg Sleep Time Awake Time 14000 CBP 5.6 sl F106 (Measured) CBP 10.0 po (Simulated) 12000 norCBP 5.6 sl F106 (Measured) norCBP 10.0

  13. Slide 13: CBP Binding Affinities for Receptors and Transporters

    CBP Binding Affinities* for Receptors and Transporters CNS PORTFOLIO H1 5-HT2A α1A α1B M1 SERT NET Cyclobenzaprine (CBP) 1.3 5.2 5.6 9.1 7.9 29 35 norCyclobenzaprine 5.6 13 34 11 30 91 2.6 (norCBP) CBP/norCBP Activity Antagonist Inhibitor CBP: more active (lower Ki) at the key receptors involved in

  14. Slide 14: Formulation with Basic Excipient Increases Systemic Absorption of Sublingual Cyclobenzaprine

    Formulation with Basic Excipient Increases Systemic Absorption of Sublingual Cyclobenzaprine1 CNS PORTFOLIO Concentration gradient increases diffusion of free base across oral mucosa (Le Chatelier’s Principle) Low pH (acidic) High pH (basic) Base (K2HPO4) CBP-HCl CBP-HCl + +f + + + + + + + + + + + +

  15. Slide 15: TNX-102 SL: Proprietary Eutectic Formulation

    TNX-102 SL: Proprietary Eutectic Formulation CNS PORTFOLIO Proprietary Cyclobenzaprine HCl Eutectic Mixture Stabilizes Sublingual Tablet Formulation Eutectic Cyclobenzaprine-HCl formulation1 (CBP-HCl) Mannitol (inactive) Base particle Base particle (K2HPO4) (K2HPO4) Base particle Cyclobenzaprine (K2

  16. Slide 16: 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

  17. Slide 17: About Fibromyalgia: Chronic Pain Disorder

    About Fibromyalgia: Chronic Pain Disorder CNS PORTFOLIO Fibromyalgia is a chronic pain disorder resulting from amplified sensory and pain signaling within the CNS – now recognized as nociplastic pain1-4 Fibromyalgia is a syndrome comprised of the symptoms: chronic widespread pain, nonrestorative sle

  18. Slide 18: Fibromyalgia is a Large, Underserved and Dissatisfied Population

    Fibromyalgia is a Large, Underserved and Dissatisfied Population CNS PORTFOLIO • More than 10 million U.S. adults are affected – predominantly women1,2 ‒ Debilitating and life altering condition ‒ Significant economic impact • Patients have expressed dissatisfaction, despite three FDA approved drugs

  19. Slide 19: Poor Sleep and Pain have Bi-directional Reinforcing Effects

    Poor Sleep and Pain have Bi-directional Reinforcing Effects1 CNS PORTFOLIO • Harvey Moldofsky – recognition of unrefreshing/non-restorative sleep in fibromyalgia • Poor sleep and pain form a vicious cycle in driving fibromyalgia decompensation • Can’t sleep → worse pain / In pain → can’t sleep • Poo

  20. Slide 20: Current FDA-Approved Fibromyalgia Drugs

    Current FDA-Approved Fibromyalgia Drugs1 CNS PORTFOLIO Improvement in fibromyalgia pain was primary endpoint for approval • No current product addresses pain, poor sleep and fatigue • Tolerability issues limit long term use for many patients Drug Lyrica® (pregabalin) - Pfizer Cymbalta® (duloxetine)

  21. Slide 21: Many Fibromyalgia Patients are Prescribed Off-Label Drugs

    Many Fibromyalgia Patients are Prescribed Off-Label Drugs; ~53% FM Patients Prescribed Opioids Off-Label1 CNS PORTFOLIO % FM Patients (after index3 date) 50% 45% 40% 35% Off-Label 30% Off-Label Off-Label FDA Approved 25.50% Opioid Opioid 25% 22.62% Off-Label 20.47% Off-Label 19.45% 20% Opioid 17.58%

  22. Slide 22: The Third Primary Type of Pain: Nociplastic Pain

    The Third Primary Type of Pain: Nociplastic Pain1-5 CNS PORTFOLIO Nociplastic syndrome includes: (1) widespread pain (2) fatigue Nociplastic Pain (3) sleep disturbances Pathological Pain (4) cognitive dysfunction (“brain fog”) Examples: Mechanism: Fibromyalgia Altered pain CFS/ ME* perception in the

  23. Slide 23: Tonix Medicines: Marketed Products

    Tonix Medicines: Marketed Products © 2025 Tonix Pharmaceuticals Holding Corp.

  24. Slide 24: Tonix Medicines: Commercial-Stage Specialty Pharma Subsidiary

    Tonix Medicines: Commercial-Stage Specialty Pharma Subsidiary CNS PORTFOLIO • Tonix Medicines is a wholly-owned subsidiary of Tonix (NASDAQ: TNXP) • Currently marketing two products indicated for the treatment of acute migraine: Zembrace® SymTouch ® and Tosymra® • Nascent commercial organization • T

  25. Slide 25: Tonix Medicines Markets Two Proprietary Migraine Drugs

    Tonix Medicines Markets Two Proprietary Migraine Drugs Non-oral Formulations of Sumatriptan CNS PORTFOLIO • Each indicated for the treatment of acute migraine with or without aura in adults Zembrace® SymTouch® • Sumatriptan remains the acute migraine ‘gold standard’ treatment for many patients and (

  26. Slide 26: TNX-1500 Anti-CD40L Monoclonal Antibody

    TNX-1500 Anti-CD40L Monoclonal Antibody Next Generation mAb preserves efficacy with reduced risk of thrombosis 26 © 2025 Tonix Pharmaceuticals Holding Corp.

  27. Slide 27: TNX-1500: Next Generation anti-CD40L mAb

    TNX-1500: Next Generation anti-CD40L mAb Re-engineered to better modulate the binding of Fc𝛄𝛄R and mitigate risk of thrombosis Clinical Stage of Phase 1 study topline results positive Key Differentiators Selectively Modified anti-CD40L AB Expected to deliver efficacy without compromising safety…

  28. Slide 28: TNX-1500 Phase 1 Topline Results and Conclusions

    TNX-1500 Phase 1 Topline Results and Conclusions IMMUNOLOGY PORTFOLIO Phase 1 design – single ascending dose study in healthy participants • Goals: Evaluate safety, pharmacodynamics and pharmacokinetics • At total of 26 participants were enrolled in three cohorts – 3 mg/kg, 10 mg/kg, and 30 mg/kg To

  29. Slide 29: TNX-1500 Strategy and Status

    TNX-1500 Strategy and Status IMMUNOLOGY PORTFOLIO 1 Proposed Initial Indication: Prevention of Allograft Rejection Status: Clinical stage Phase 1 completed – positive topline reported in 1st Quarter 2025 Collaborations ongoing with Mass General Hospital on heart and kidney transplantation in non-hum

  30. Slide 30: Team, Network, & Upcoming Milestones

    TEAM, Network, & Upcoming Milestones © 2025 Tonix Pharmaceuticals Holding Corp.

  31. Slide 31: Management Team

    Management Team Seth Lederman, MD Co-Founder, CEO & Chairman Gregory Sullivan, MD Chief Medical Officer Bradley Saenger, CPA Chief Financial Officer Jessica Morris Chief Operating Officer Siobhan Fogarty Chief Technical Officer 31 © 2025 Tonix Pharmaceuticals Holding Corp.

  32. Slide 32: Key Partnerships

    Key Partnerships TNX-1500: ALLOGRAFT REJECTION TNX-1300: COCAINE INTOXICATION TNX-102 SL: ACUTE STRESS DISORDER TNX-1800: COVID-19 VACCINE TNX-2900: PRADER-WILLI SYNDROME TNX-4200: BROAD-SPECTRUM ANTIVIRAL 32 © 2025 Tonix Pharmaceuticals Holding Corp.

  33. Slide 33: Milestones: Recently Completed and Upcoming

    Milestones: Recently Completed and Upcoming TNX-102 SL for the Management of Fibromyalgia Milestones   3rd Quarter 2024 FDA Fast Track Designation granted by FDA   October 2024 Submitted NDA to FDA for TNX-102 SL for fibromyalgia in October 2024   December 2024 FDA assigned a PDUFA* goal date

  34. Slide 34: Thank You

    THANK YOU © 2025 Tonix Pharmaceuticals Holding Corp.

  35. Slide 35: 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

  36. Slide 36: 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

  37. Slide 37: 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

  38. Slide 38: 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

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