Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Technical Presentation (November 2023)

24 slides from Tonix Pharmaceuticals's technical presentation, Nov 15, 2023

Slide 1: TNX-1900 Chronic Migraine
© 2023 Tonix Pharmaceuticals Holding Corp. TNX - 1900 Chronic Migraine NASDAQ: TNXP Version P0500 November 13, 2023 (Doc 1341)
Slide 2: Cautionary Note on Forward-Looking Statements
2 © 2022 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
Slide 3: TNX-1900 for the Treatment of Migraine: Prevalence
3 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 1900 for the Treatment of Migraine: Prevalence One billion individuals worldwide suffer from migraines (~14% of population) 1 Migraine is the second leading cause of years lived with disability 1 In U.S., the estimated cost of all migr
Slide 4: TNX-1900 for the Treatment of Migraine and Craniofacial Pain: Overview
4 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 1900 for the Treatment of Migraine and Craniofacial Pain: Overview Novel intranasal oxytocin formulation being developed as a prophylactic treatment for chronic migraine • Based on a propriety formulation of oxytocin*, a naturally occu
Slide 5: TNX-1900 for the Treatment of Migraine: Mechanism of Action
5 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 1900 for the Treatment of Migraine: Mechanism of Action Preclinical research showed that nasally applied TNX - 1900 selectively inhibits the activity of trigeminal pain - sensing nerve cells and blocks the release of CGRP • TNX - 1900
Slide 6: Efficacy of Intranasal Oxytocin After Inflammation of the TMJ
6 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Efficacy of Intranasal Oxytocin After Inflammation of the Temporomandibular Joint (TMJ) Pre 1 2 3 0 1 2 3 4 * * Intervention Days after TMJ Inflammation Pain index (amount consumed in grams) IN = intranasal; IV = interveinal; OXT = oxytocin;
Slide 7: Effects of IN OXT on Trigeminal Nerve Nuclei Neuron Activity
7 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Effects of IN OXT on Trigeminal Nerve Nuclei Neuron Activity Induced by Noxious Electrical Stimulation to the Face. 5 0 200 400 600 Action potentials/30 stimuli Time (minutes) after intranasal OXT pre pre 5 10 15 20 25 30 35 40 45 50 55 60 6
Slide 8: Thermal Hyperalgesia in Inflamed Facial Skin
8 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Thermal Hyperalgesia in Inflamed Facial Skin OXT = oxytocin; * P <0.05; N = 6 per group Tzavazis A., et al. Headache, 2017;57:64 - 75) Saline OXT Treatments 0 5 10 15 20 Withdrawal latency (seconds) * * * * * *
Slide 9: Reduced Food Intake with TMJ Pain
9 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Reduced Food Intake with TMJ Pain OXT OXT IV AT + OXT Treatments 0 1 2 3 4 Food intake (grams) * * OXT = oxytocin; AT = Atosiban ® ; IV = interveinal; * P <0.05; N = 8 per group Tzavazis A., et al. Headache, 2017;57:64 - 75)
Slide 10: Mechanical Allodynia in Trigeminal Neuralgia
10 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Mechanical Allodynia in Trigeminal Neuralgia baseline pre 0 0.2 0.4 0.6 0.8 Degree of response post * * † † Carbamazepine Oxytocin Treatments * P <0.05 pre vs baseline; † P<0.5 pre vs post; N = 4 per group Tzavazis A., et al. Headache, 2017
Slide 11: Mechanical Allodynia After Facial Incision
11 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Mechanical Allodynia After Facial Incision 0 0.2 0.4 0.6 0.8 50% withdrawal threshold (grams) Saline OXT Treatments Intranasal administration * * * OXT = oxytocin; * P <0.05; N = 6 per group Tzavazis A., et al. Headache, 2017;57:64 - 75)
Slide 12: Totaled Responses of Representative Neuron Before and After IN OXT
12 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Totaled Responses of Representative Neuron Showing Overall Number of Action Potentials Before and After IN OXT Administration 5 0 200 400 600 Action potentials/30 stimuli Time (minutes) after intranasal OXT pre pre 5 10 15 20 25 30 35 40 45
Slide 13: Recordings of Trigeminal Nuclei Neuron Before and After IN OXT
13 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Recordings of Trigeminal Nuclei Neuron Before IN OXT Administration And After IN OXT Administration 20 - 1.0 - 1.0 0.0 0.0 1.0 1.0 25 30 35 40 45 50 55 60 Before IN OXT 45 minutes after IN OXT Time [seconds] Voltage [volts] IN OXT = intrana
Slide 14: TNX-1900 for Migraine: Magnesium is at the Core of Oxytocin Binding
14 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 1900 for Migraine Magnesium (Mg 2+ ) is at the Core of Oxytocin Binding 1 1 Adapted from Meyerowitz, J.G., Robertson, M.J., Barros - Álvarez, X. et al. The oxytocin signaling complex reveals a molecular switch for cation dependence. N
Slide 15: Addition of Mg2+ Augments Oxytocin-Induced Analgesia in Animal Model
15 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Bharadwaj VN, et al. Pharmaceutics . 2022;14(5):1105. in vivo effect of Mg 2+ ion addition with intranasal oxytocin - induced craniofacial analgesia on the withdrawal response time to noxious heat stimulation of the cheek of pre - inflamed
Slide 16: TNX-1900 Profile and Development Program
16 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 1900*: Prevention of Headache in Chronic Migraine Intranasal Potentiated Oxytocin (OT) with Magnesium CNS PORTFOLIO • Intranasal OT has potential utility in treating migraine 1 • Magnesium is
Slide 17: TNX-1900 Phase 2 PREVENTION Study Design
17 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 1900: Phase 2 PREVENTION Study Design General s tudy c haracteristics: • Randomized, double - blind, placebo - controlle d study (three arms – two treatment regimens and one placebo) in chronic migraine • U.S. sites only • Fully enrol
Slide 18: TNX-1900 for the Treatment of Migraine: Mechanism of Action (continued)
18 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 1900 for the Treatment of Migraine: Mechanism of Action (continued) HEAD PAIN PATIENT USES TNX - 1900 TARGETED DELIVERY Permeates nasal mucosa Transported to trigeminal system and brain Proprietary Nasal to Brain Delivery CGRP: NEUROT
Slide 19: Intranasal oxytocin concentrates in the trigeminal system in animal models
19 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO In animal models, intranasal oxytocin concentrates in the trigeminal system I nhibits trigeminal neuronal firing, and decreases CGRP (and PACP) release onto meningeal vasculature and within the brainstem • Believed to have effects on: - Neu
Slide 20: Potential Applications of TNX-1900 & TNX-2900: Investigator Led Studies
20 © 2022 Tonix Pharmaceuticals Holding Corp. Potential Applications of TNX - 1900 & TNX - 2900: Investigator Led Studies Adolescent Obesity Binge Eating Dis. Eating Behavior and Weight Disorders Autism Social Functioning Disorders Social Anxiety Disorder Migraine Craniofacial Pain Pain Conditions P
Slide 21: TNX-1900 Other Studies in Collaboration with Academic Investigators
21 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 1900 – Other Studies in Collaboration with Academic Investigators Pharmacodynamic biomarker study related to headache 1 ‒ Testing TNX - 1900 effects on capsaicin - or electrical stimulation - induced forehead dermal blood flow in heal
Slide 22: TNX-1900 for Pediatric Autism
22 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 1900 for Pediatric Autism • Children with Autism Spectrum Disorder (ASD) are at risk for low bone density • Preliminary data s uggest that administration of oxytocin may f avorably impact bone f ormation and strength • Recent meta - a
Slide 23: Rare Disease Portfolio: TNX-2900 for Prader-Willi Syndrome
23 © 2022 Tonix Pharmaceuticals Holding Corp. RARE DISEASE PORTFOLIO Rare genetic diseas e that afflicts 10 - 20 thousand individuals in the US TNX - 2900 for Prader - Willi Syndrome Prader - Willi Syndrome (PWS) is the most common genetic cause of life - threatening childhood obesity. PWS causes un

Tonix Pharmaceuticals Holding — Technical Presentation (November 2023) on 6ix

Tonix Pharmaceuticals — Technical Presentation (November 2023)

Slide 1: TNX-1900 Chronic Migraine

Slide 2: Cautionary Note on Forward-Looking Statements

Slide 3: TNX-1900 for the Treatment of Migraine: Prevalence

Slide 4: TNX-1900 for the Treatment of Migraine and Craniofacial Pain: Overview

Slide 5: TNX-1900 for the Treatment of Migraine: Mechanism of Action

Slide 6: Efficacy of Intranasal Oxytocin After Inflammation of the TMJ

Slide 7: Effects of IN OXT on Trigeminal Nerve Nuclei Neuron Activity

Slide 8: Thermal Hyperalgesia in Inflamed Facial Skin

Slide 9: Reduced Food Intake with TMJ Pain

Slide 10: Mechanical Allodynia in Trigeminal Neuralgia

Slide 11: Mechanical Allodynia After Facial Incision

Slide 12: Totaled Responses of Representative Neuron Before and After IN OXT

Slide 13: Recordings of Trigeminal Nuclei Neuron Before and After IN OXT

Slide 14: TNX-1900 for Migraine: Magnesium is at the Core of Oxytocin Binding

Slide 15: Addition of Mg2+ Augments Oxytocin-Induced Analgesia in Animal Model

Slide 16: TNX-1900 Profile and Development Program

Slide 17: TNX-1900 Phase 2 PREVENTION Study Design

Slide 18: TNX-1900 for the Treatment of Migraine: Mechanism of Action (continued)

Slide 19: Intranasal oxytocin concentrates in the trigeminal system in animal models

Slide 20: Potential Applications of TNX-1900 & TNX-2900: Investigator Led Studies

Slide 21: TNX-1900 Other Studies in Collaboration with Academic Investigators

Slide 22: TNX-1900 for Pediatric Autism

Slide 23: Rare Disease Portfolio: TNX-2900 for Prader-Willi Syndrome

Slide 24: Thank You