Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (August 2023)
54 slides from Tonix Pharmaceuticals's investor presentation, Aug 1, 2023
Slide 1: Investor Presentation
INVESTOR PRESENTATION NASDAQ: TNXP
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
Slide 3: Investment Highlights
Investment Highlights DIVERSE PIPELINE Tonix’s core focus is on central nervous system disorders, but we also target unmet needs across multiple “ <8" therapeutic areas including immunology, infectious disease and rare disease. é , fe) IN-HOUSE CAPABILITIES it % Investment in domestic, in-house, R&D
Slide 4: Pipeline: Key Clinical Development Programs
Pipeline: Key Clinical Development Programs Candidates* Indication Status/Next Milestone aces Fibromyalgia (FM) Mid-Phase 3 — enroliment complete Long COVID (PASC?) Phase 2 — enrollment complete TNX-1300° Cocaine Intoxication - FDA Breakthrough Designation Mid-Phase 2, Targeted 3 2023 Start TNX-1900
Slide 5: Late-Stage CNS Programs
Late-Stage CNS Programs’ Four Studies Expecting Topline in the Next Three Quarters (by End of 1924) Active Studies * 23Q3 - Topline: omM04LYOd SND @ - TNX-102 SL for fibromyalgia-type Long COVID (enrollment complete) = P2 Proc + 23Q4 — Topline: 7, - TNX-1900 for migraine headache (enrollment complet
Slide 6: Tonix Medicines is our Commercial Subsidiary
Tonix Medicines is our Commercial Subsidiary Marketed products for the treatment of acute migraine in adults with or without aura Zembrace® SymTouch® (sumatriptan injection) 3 mg’ Tosymra® (sumatriptan nasal spray) 10 mg? — Both are proprietary non-oral formulations of sumatriptan that bypass the ga
Slide 7: CNS: Key Development Candidates
TONIX PHARMACEUTICALS CNS: KEY DEVELOPMENT CANDIDATES
Slide 8: TNX-102 SL Fibromyalgia and Long COVID
TNX-102 SL* I vscomyatci Cyclobenzaprine (Protectic®) Status: Mid-Phase 3 + One positive Phase 3 study (RELIEF) completed Pipeline in a Product + Second Phase 3 study (RALLY) missed primary endpoint A unique, sublingual formulation of cyclobenzaprine designed + Confirmatory Phase 3 study (RESILIENT)
Slide 9: TNX-102 SL (Sublingual Cyclobenzaprine HCl tablets)
TNX-102 SL (Sublingual Cyclobenzaprine HCI tablets*) Proprietary cyclobenzaprine HCI eutectic mixture stabilizes sublingual tablet formulation 0M04LYOd SND Cyclobenzaprine-HCl agit” e wx Protectic™ =~ © Eutectic i (CBP-HCI) o formulation’ é wo ANGSTRO- ‘ie Mannitol (inactive) TECHNOLOG 4 yu Base g B
Slide 10: TNX-102 SL Sublingual Administration
TNX-102 SL Sublingual Administration* Transmucosal absorption avoids first pass hepatic metabolism OM04LYOd SND @ Swallowed Oral Dose Sublingual Oral Dose nr Cyclobenzaprine Cyclobenzaprine Le™ L va ad ig ~ Noreyclobenzaprine Absorption Zs ver 7 welts Hepatic Veiniin. Vena Cava ) Brain > 2+ Hours ‘i
Slide 11: TNX-102 SL: Fibromyalgia
TNX-102 SL*: Fibromyalgia Cyclobenzaprine Protectic® Sublingual Tablets PROFILE Fibromyalgia (FM) is a chronic pain disorder resulting from amplified sensory and pain signaling within the CNS + Afflicts an estimated 6-12 million adults in the U.S., approximately 90% of whom are woment + Symptoms inc
Slide 12: RESILIENT Study Design
Ww, RESILIENT “a Study TNX-102 SL: Phase 3 RESILIENT Study Design General study characteristics: + Randomized, double-blind, placebo-controlled study in fibromyalgia + U.S. sites only, completed enrollment of 457 patients Primary Endpoii + Daily diary pain severity score change from baseline to Week
Slide 13: TNX-102 SL: Fibromyalgia-Type Long COVID (PASC)
TNX-102 SL*: Fibromyalgia-Type Long COVID (PASC) Cyclobenzaprine Protectic® Sublingual Tablets PROFILE + Occurs in approximately 13% of recovered COVID-19 patients* As many as 40% of Long COVID patients experience multi-site pain, a hallmark of fibromyalgia? Symptoms of Long COVID, like multi-site p
Slide 14: Fibromyalgia-Type Long COVID
Fibromyalgia-Type Long COVID + Long COVID isa heterogeneous condition that displays elements of nociplastic > pain in many individuals, who experience otherwise unexplained symptoms" Pe . Nociceptive pain 01M04LYOd SND ‘Symptoms (mult sleep disorders and cognit Nociplastic pain‘: (new term for “Cent
Slide 15: TNX-102 SL: Phase 2 PREVAIL Study Design
TNX-102 SL: Phase 2 PREVAIL Study Design Study characteristics: + Randomized, double-blind, placebo-controlled study of TNX-102 SL in fibromyalgia-type Long COVID + US. sites only, completed enrollment of 63 patients PREVAIL Study 0M04LYOd SNO Primary Endpoint: * Daily diary pain severity score chan
Slide 16: TNX-601 ER: Depression
TNX-601 ER*: Depression Tianeptine Hemioxalate Extended-Release Tablets (39.4 mg) ° 2 G PROFILE DEVELOPMENT PROGRAM 3} + Anovel, oral, extended-release once-daily tablet k : Major De i a + Treatment effect of tianeptine sodium immediate release Market Entry: Major Depressive Dicodag/MDD) 3} tid. in
Slide 17: TNX-601 ER Phase 2 UPLIFT Study Design
TNX-601 ER - Phase 2 UPLIFT* Study Design UPLIF Tstugy General study characteristics: + Randomized, double-blind, placebo-controlled study in Major Depressive Disorder to evaluate monotherapy with TNX-601 ER versus placebo. + Parallel design with two arms — treatment with tianeptine hemioxalate 39.4
Slide 18: Tianeptine is a PUFA Analogue
2 Wikipedia: htpsilen wiped. crgwik/Docosahexaencic_ acid StHeath Rd, and Wood TR, 2021, int J Mol Se, 202% 22(21):11826 Liao etal, 2019, Tans! Psychiatry. 9(1):190 (© 2028 Tonix Pharmaceuticals Holding Corp, Tianeptine is a Polyunsaturated Fatty Acid (PUFA) Analogue PUFAs and PUFA-analogues + Polar
Slide 19: TNX-601 ER: Racemic Tianeptine, Two Isomers
TNX-601 ER — Racemic Tianeptine - Composed of Two Isomers Racemic tianeptine: + Approved in Europe and ex-US + 1:1 mixture of 2 mirror-image isomers*? + Weak p-opioid receptor agonism? + Risk of abuse or diversion for euphoric effects? Activates PPAR-B/5 Neuroplasticity Novel Object Test® t-Opioid R
Slide 20: TNX-4300: Depression, Alzheimer's & Parkinson's diseases
TNX-4300*: Depression, Alzheimer’s & Parkinson’s diseases Estianeptine (Single (S)-isomer of Tianeptine) PROFILE + Single isomer, oral treatment + Proposed mechanism of action from lab studies indicates estianeptine is the active ingredient of TNX-601 ER? + PPAR-B/d and PPAR-y agonist + Free of u-op
Slide 21: Monoaminergic Antidepressants vs (S)-Tianeptine
While Monoaminergic Antidepressants Work at the Synapse, (S)-Tianeptine “Cuts in Line” to More Directly Affect Neuroplasticity’ eos Depressed - (7 Monoaminergic ~\>~~_ “antidepressants “\. ~~~~ / ‘ =n y-4, AN. wees msc, 4. Direct action at nuclear PPAR-B/5, 1, Neurotransmitter 2. Increased synaptic
Slide 22: Tianeptine Shares a Neuroplasticity-Promoting Mechanism With Psychedelics
Tianeptine Shares a Neuroplasticity-Promoting Mechanism With Psychedelics The neurotrophic growth factor BDNF plays a key role in the regulation of synaptic plasticity, and is diminished in populations suffering from anxiety and depression’ + Psychedelics may promote neuroplasticity both by directly
Slide 23: TNX-1900: Prevention of Headache in Chronic Migraine
TNX-1900*: Prevention of Headache in Chronic Migraine Intranasal Potentiated Oxytocin (OT) with Magnesium fe) é PROFILE DEVELOPMENT PROGRAM 3} + Intranasal OT has potential utility in treating migraine’ Market Entry: Chronic Migraine 4 + Magnesium is known to potentiate the binding of OT to its Q re
Slide 24: TNX-1900: Phase 2 PREVENTION Study Design
TNX-1900: Phase 2 PREVENTION Study Design General study characteristics: Randomized, double-blind, placebo-controlled study (three arms— two treatment regimens and one placebo) in chronic migraine USS. sites only Fully enrolled with 88 patients Topline results expected 4Q’23 Primary Endpoint: Mean c
Slide 25: Pharmacodynamic biomarker study related to headache
Pharmacodynamic biomarker study related to headache! = _ Testing TNX-1900 effects on capsaicin- or electrical stimulation-induced forehead dermal blood flow in healthy female human volunteers = Forehead dermal blood flow is considered a trigeminovascular biomarker for antimigraine drugs. * Both a CG
Slide 26: TNX-1300: Cocaine Intoxication
TNX-1300*: Cocaine Intoxication Cocaine Esterase (CocE) PROFILE DEVELOPMENT PROGRAM Cocaine is the main cause for drug-related ED visits’ Market Entry: Cocaine Intoxication CocE is a recombinant protein that degrades cocaine in the bloodstream 1O4LHOd SND Status: Mid-Phase 2 t + Rapidly reverses phy
Slide 27: Rare Disease: Key Candidates
TONIX PHARMACEUTICALS RARE DISEASE: KEY CANDIDATES
Slide 28: TNX-2900: Hyperphagia in Prader-Willi Syndrome
TNX-2900*: Hyperphagia in Prader-Willi Syndrome Intranasal Potentiated Oxytocin (OT) with Magnesium Status: Phase 2 ready 2 =e 5 PROFILE DEVELOPMENT PROGRAM a Prader-Willi Syndrome is the most common genetic Market Entry: Hyperphagia in Prader-Willi @ cause of life-threatening childhood obesity Synd
Slide 29: Immunology: Key Candidates
TONIX PHARMACEUTICALS IMMUNOLOGY: KEY CANDIDATES
Slide 30: TNX-1500
TNX-1500* Next Generation a-CD40 Ligand (CD40L) Antibody The CD40-CD40L pathway is a pivotal immune system modulator and a well-established and promising treatment target Differentiators: Expected to deliver efficacy without compromising safety First Generation: Development h (TE) complications—bloo
Slide 31: Third-Generation a-CD40L
Third-Generation a-CD40L Engineered to Decrease Risk of Thrombosis = = c z - fe} First-generation Second-generation Third-generation o anti-CD40L mAbs anti-CD40L proteins anti-CD40L mAbs* @ 3 fe} a a n fe} © fo} Ruplizumab Aglycosyl Dapirolizumab Letolizumab —_Dazodalibep TNX-1500 Ruplizumab Constan
Slide 32: Other anti-CD40L Monoclonal Antibodies in Development
Other anti-CD40L Monoclonal Antibodies in Development @ UCB (Co-developed with Biogen) ~ Systemic Lupus Erythematosus (SLE) + Phase 3 Trial Currently Enrolling (NCT04294667) - Topline results expected 1H 2024" Dapirolizumab pegol (pegylated Fab) | ad Horizon (being acquired by Amgen) - Sjégren's Syn
Slide 33: Infectious Disease: Key Candidates
TONIX PHARMACEUTICALS INFECTIOUS DISEASE: KEY CANDIDATES
Slide 34: TNX-801
TNX-801* ‘scHPXV (Horsepox) 212,811 bp teste tp couticals Holding Corp.
Slide 35: Live Virus Vaccine Platform: Recombinant Pox Vaccine (RPV)
Live Virus Vaccine Platform: Recombinant Pox Vaccine (RPV) Technology for Emerging Infectious Diseases and Oncolytics Mpox and Smallpox CoviD-19 yf a ANTIG! Future Pandemics & N mi Vaccinia Horsepox . uture Pandemics & New_ CODIN Infectious Diseases 8 a a fe} iss Biodefense . Oncology RPV VECTOR BEL
Slide 36: Tonix Medicines: Marketed Products
TONIX MEDICINES: MARKETED PRODUCTS
Slide 37: Two Marketed Proprietary Migraine Drugs
@ Two Marketed Proprietary Migraine Drugs Autoinjector and Nasal Spray (Non-oral) Formulations of Sumatriptan Zembrace® SymTouch® (sumatriptan injection) 3 mg* Tosymra® (sumatriptan nasal spray) 10 mg? — Each indicated for the treatment of acute migraine with or without aura in adults ~ Sumatriptan
Slide 38: Zembrace SymTouch (sumatriptan injection) 3 mg
Zembrace® SymTouch® (sumatriptan injection) 3 mg Indication — Indicated for the treatment of acute migraine with or without aura in adults 104LHOd SND. Design — Only branded sumatriptan autoinjector professionally promoted in the United States — Designed for ease of use and favorable tolerability wi
Slide 39: Tosymra (sumatriptan nasal spray) 10 mg
@ Tosymra® (sumatriptan nasal spray) 10 mg Indication — Indicated for the treatment of acute migraine with or without aura in adults 1O4LNOd SND Design ~ Novel intranasal sumatriptan product formulated with a permeation enhancer (Intravail® tc provides rapid and efficient absorption of sumatriptan’?
Slide 40: Potential for Zembrace and Tosymra in Evolving Migraine Market
Potential for Zembrace and Tosymra in Evolving Migraine Market Documented efficacy of Zembrace’ and Tosymra®* as abortive treatments for acute migraine — Migraine pain relief possible in as few as 10 minutes for some patients and convenient administration — Potential to address the unmet needs of pa
Slide 41: Administration of Zembrace and Tosymra Bypass the GI Tract
Administration of Zembrace and Tosymra Bypass the GI Tract Bypassing the gastrointestinal (Gl) tract is a potential advantage for treating acute migraine — Potential to provide a treatment option for migraines complicated by severe nausea and vomiting 01041LYOd SND Need for acute non-oral treatments
Slide 42: Strategic Fit
Strategic Fit We expect commercial business of Zembrace and Tosymra will be under our control in 4Q’23: same as projected topline for fibromyalgia Phase 3 study — With success in F307 trial, commercial business is expected to speed TNX-102 SL launch " — Commercial business has potential to expand =
Slide 43: Value to Tonix of Marketed Proprietary Migraine Drugs
Value to Tonix of Marketed Proprietary Migraine Drugs Prepare for the launch of TNX-102 SL for fibromyalgia — Commercial capabilities prior to expected launch of TNX-102 SL may speed market uptake — Potential to facilitate launch of TNX-1900 for prevention of chronic migraine once approved = Overlap
Slide 44: Preclinical Pipeline
TONIX PHARMACEUTICALS. PRECLINICAL PIPELINE
Slide 45: Internal Development & Manufacturing Capabilities
Internal Development & Manufacturing Capabilities R&D Center (RDC) — Frederick, MD + Functions: — Research advancing CNS and immunology drugs - Accelerated development of vaccines and antiviral drugs against COVID-19, its variants and other infectious diseases + Description: ~48,000 square feet, BSL
Slide 46: Pipeline: Key Pre-Clinical Programs
Pipeline: Key Pre-Clinical Programs Candidates* Indication Status/Next Milestone TNX-1610' Attention Deficit Hyperactivity Disorder (ADHD) Preclinical TNX-17002 Gastric and colorectal cancers Preclinical TNX-1850° COVID-19 (horsepox-based live virus vaccine platform) Preclinical TNX-801¢ ‘Smallpox a
Slide 47: Tonix Team, Network and Future Outlook
TONIX PHARMACEUTICALS TONIX TEAM, NETWORK AND FUTURE OUTLOOK
Slide 48: Key Development Partners
Key Development Partners Couumsia MASSACHUSETTS. ONIVERSINY (GENERAL HOSPITAL MEDICAL SCHOOL cb Hoe : TNX-1300: COCAINE INTOXICATION USD EELS BI Mele fo ete) TNX-1700: GASTRIC AND COLORECTAL CANCERS ip Université university oF 2) DE GENEVE ALBERTA TNX-801: SMALLPOX AND MONKEYPOX VACCINE TNX-1850: CO
Slide 49: Milestones: Recently Completed and Upcoming
Milestones: Recently Completed and Upcoming 2" Quarter 2022 Phase 3 RESILIENT study start of TNX-102 SL for the management of fibromyalgia @2rd Quarter 2022 Phase 2 PREVAIL study start of TNX-102 SL for the treatment of fibromyalgia-type Long COVID 1° Quarter 2023 Phase 2 PREVENTION study start of T
Slide 50: Thank You
THANK YOU
Slide 51: Zembrace Important Safety Information (1 of 2)
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 a heart attack: + Discomfort in the center of your chest tha
Slide 52: Zembrace Important Safety Information (2 of 2)
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, nausea or: vomiting, constipation or diarrhea, bloody diarrhea, fever; cr
Slide 53: Tosymra Important Safety Information (1 of 2)
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 attack: + Discomfort in the center of your chest that lasts for
Slide 54: Tosymra Important Safety Information (2 of 2)
Tosymra® IMPORTANT SAFETY INFORMATION (2 of 2) 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, fever; cramp
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