Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (June 2024)
82 slides from Tonix Pharmaceuticals's investor presentation, Jun 10, 2024
Slide 1: Corporate Presentation: Focus on Tonmya (TNX-102 SL) for Fibromyalgia
© 2024 Tonix Pharmaceuticals Holding Corp. Corporate Presentation Focus on: Tonmya * (TNX - 102 SL) in Development for the Management of Fibromyalgia June 2024 NASDAQ: TNXP *Tonmya is conditionally accepted by FDA as the tradename for TNX - 102 SL for the management of fibromyalgia Version P0574 Jun
Slide 2: Cautionary Note on Forward-Looking Statements
2 © 2024 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: Who We Are
3 © 2024 Tonix Pharmaceuticals Holding Corp. Tonix is committed to developing and marketing therapeutics to treat pain, neurologic, psychiatric and addiction conditions through our central nervous system portfolio and within other areas of high unmet need , including immunology, infectious disease,
Slide 4: CNS-Focused Biopharma with Preclinical, Clinical and Commercial Stage Products
4 © 2024 Tonix Pharmaceuticals Holding Corp. CNS - Focused Biopharma with Preclinical, Clinical and Commercial Stage Products Marketed Products • Zembrace ® and Tosymra ® indicated for the treatment of acute migraine Tonmya fo r Fibromyalgia: Preparing New Drug Application (NDA) • Two Phase 3 trials
Slide 5: Key Clinical Programs
5 © 2024 Tonix Pharmaceuticals Holding Corp. NDA Submission Phase 3 Phase 2 Phase 1 Indication Molecule * Fibromyalgia Tonmya TNX - 102 SL Cyclobenzaprine HCl Protectic ® Sublingual Tablets Long COVID Acute Stress Disorder Cocaine Intoxication TNX - 1300 Cocaine Esterase NIDA Funded Prader - Willi S
Slide 6: CNS: Key Development Candidates
© 2024 Tonix Pharmaceuticals Holding Corp. CNS: KEY DEVELOPMENT CANDIDATES
Slide 7: About Fibromyalgia
7 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO About Fibromyalgia Fibromyalgia is considered a chronic overlapping pain condition (COPC) - the only COPC with any FDA - approved drugs 3 Fibromyalgia is the prototypic nociplastic syndrome Multisite pain Fatigue Non - Restorative Sleep Fibr
Slide 8: Fibromyalgia is a Large, Underserved and Dissatisfied Population
8 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fibromyalgia is a Large, Underserved and Dissatisfied population 1 American College of Rheumatology ( www.ACRPatientInfo.org accessed May 7, 2019) – prevalence rate of 2 - 4% for U.S. adult population (~250 million) 2 Vincent A, et al. Arthr
Slide 9: Tonmya (TNX-102 SL, Cyclobenzaprine HCl Sublingual Tablets)
9 © 2024 Tonix Pharmaceuticals Holding Corp. Tonmya (TNX - 102 SL, Cyclobenzaprine HCl Sublingual Tablets) A unique, sublingual formulation of cyclobenzaprine designed to optimize delivery and absorption Tonmya is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename
Slide 10: Tonmya (TNX-102 SL, Cyclobenzaprine HCl Sublingual Tablets)
10 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tonmya (TNX - 102 SL, Cyclobenzaprine HCl Sublingual Tablets) 1 • Non - opioid analgesic designed for long - term daily bedtime use in fibromyalgia patients ‒ Targets non - restorative sleep ‒ Potent binding and antagonist activities at fou
Slide 11: TNX-102 SL: Unique MOA Facilitates Restorative Sleep
TNX - 102 SL: Unique MOA Facilitates Restorative Sleep Centrally Acting Analgesic 11 Potent binding and antagonist activities at four key receptors facilitate restorative sleep • serotonergic - 5 - HT2A • adrenergic - α1 • histaminergic - H1 • muscarinic - M1 Relative to Oral Cyclobenzaprine o Lower
Slide 12: The Third Type of Pain: Nociplastic Pain
12 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO The Third Type of Pain: Nociplastic Pain 1 1 Trouvin AP, et al. Best Pract Res Clin Rheumatol . 2019;33(3):101415. Nociplastic syndrome includes : (1) widespread pain (2) fatigue (3) sleep disturbances (4) cognitive dysfunction (“brain fog”
Slide 13: Fibromyalgia is Believed to Result from Chronic Pain or Prior Stress Experiences
13 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fibromyalgia is Believed to Result from Chronic Pain or Prior Stress Experiences Stresses that may precede or precipitate FM include : Chronic nociceptive pain • e.g. , osteoarthritis Chronic neuropathic pain • e.g. , diabetic neuropathy In
Slide 14: Common Chronic Conditions are a Challenge for Pharma
14 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Common Chronic Conditions are a Challenge for Pharma Fibromyalgia is a common chronic disease 1 • Chronic pain syndrome that persists for years or decades No animal model is recognized for nociplastic syndromes or its component symptoms • W
Slide 15: Common Chronic Conditions are a Challenge for Society
15 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Common Chronic Conditions are a Challenge for Society The Opiate Crisis in the U.S. was driven by mistreatment of chronic pain, which was often nociplastic pain • The e pidemic of prescription pain killers was addressed by regulations which
Slide 16: Fibromyalgia: Market Characteristics
16 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fibromyalgia: Market Characteristics Prevalence • One of the more common chronic pain disorders (2 - 4% of US Population) 1 Diagnosed population • Large population but underdiagnosed 2 relative to prevalence rate • Majority receive drug tre
Slide 17: Fewer than Half of Those Treated Receive Sustained Benefit from Approved Drugs
17 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fewer than Half of Those Treated for Fibromyalgia Receive Sustained Benefit from the Three FDA - Approved Drugs 1 Respond, but intolerant of side effects Do not respond 25% 35% 60% fa il ure rate 1 The three drugs with FDA approval for the
Slide 18: Current FDA-Approved Fibromyalgia Drugs were Repurposed
18 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Current FDA - Approved Fibromyalgia Drugs were Repurposed 1 1 The three drugs with FDA approval for the treatment of fibromyalgia: Pregabalin (Lyrica); Duloxetine (Cymbalta); Milnacipran ( Savella ) Cymbalta® - Lilly Savella ® - AbbVie Lyri
Slide 19: Large Need for New Fibromyalgia Therapies with Better Tolerability
19 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Large Need for New Fibromyalgia Therapies that Provide Broad Symptom Improvement with Better Tolerability • Currently - approved medications may have side effects that limit long - term use 1 • Many patients skip doses or discontinue altoge
Slide 20: Fibromyalgia Program Status
20 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fibromyalgia Program Status Fibromyalgia Tonmya * (TNX - 102 SL) Cyclobenzaprine Protectic ® Sublingual Tablets Statistically Significant 2 nd Phase 3 Topline Results Reported 4Q’23 First pivotal Phase 3 study ( RELIEF ) reported – December
Slide 21: Tonmya Phase 3 RESILIENT Study Design
21 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tonmya (TNX - 102 SL): P hase 3 RESILIENT Study Design General s tudy c haracteristics: • Randomized, double - blind, multicenter, placebo - controlle d study in fibromyalgia • 33 U.S. sites enrolled 457 participants with fibromyalgia as de
Slide 22: RESILIENT Primary Outcome: Reduction in Widespread Pain
22 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Weekly Average of Daily Diary NRS Ratings of Average Pain Over Prior 24 Hours RESILIENT Primary Outcome Measure 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
Slide 23: Summary of Key Pre-Specified Secondary Outcome Measures
23 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Summary of Key Pre - Specified Secondary Outcome Measures *In order of statistical serial gate - keeping hierarchy (or, “waterfall”) to control overall Type 1 error **Statistical significance met Met** Week 14 Rating Scale p < 0.001 Patie
Slide 24: RESILIENT Pre-Specified Primary Endpoint Summary
24 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT Pre - Specified Primary Endpoint Summary 1 • Tonmya (TNX - 102 SL) demonstrated statistically significant improvement in mean weekly pain scores over placebo at Week 14 • P - value of 0.00005 is highly statistically significant Ad
Slide 25: RESILIENT Safety Summary
25 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT Safety Summary Among participants randomized to Tonmya (TNX - 102 SL) and to placebo, 81.0% and 79.6%, respectively, completed the study Tonmya (TNX - 102 SL) was generally well tolerated with an adverse event (AE) profile compara
Slide 26: RESILIENT Safety Summary: Adverse Events
26 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT Safety Summary *Safety Population Treatment - Emergent Adverse Events (TEAEs) at Rate of ≥ 3% in Either Treatment Group Changes in Sexual Functioning Questionnaire short form (CSFQ - 14) was a safety measure in the study • In fema
Slide 27: Tonmya Showed Broad-Spectrum Activity and was Well Tolerated
27 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tonmya Showed Broad - Spectrum Activity and was Well Tolerated Tonmya Cymbalta® Savella ® Lyrica® YES YES YES Pain Activity YES - YES Sleep YES YES - Fatigue - + - Insomnia Systemic Tolerability Issues - - + Fatigue - - + Weight - + - Blood
Slide 28: ~50% of U.S. Fibromyalgia Patients are on Medicare
28 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO ~50% of U.S. Fibromyalgia Patients are on Medicare: Prescription Coverage in Medicare Stands to Benefit from Changes in IRA Approximately 50% of fibromyalgia patients are on Medicare ‒ EVERSANA analysis of claims database consisting of 2.2M
Slide 29: Prescribers Broadly Dissatisfied with Available Fibromyalgia Medications
29 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Prescribers Interviewed are Broadly Dissatisfied with Available Fibromyalgia Medications: Results of Primary Research 1 Perspectives on FM Therapies from Prescribers Interviewed Negatives Positives Drug • Tolerability issues: worsening depr
Slide 30: Opportunity for a New, Unique Fibromyalgia Treatment Option
30 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Opportunity for a New, Unique Fibromyalgia Treatment Option: Results of Primary Research from EVERSANA 1,2 • Prescribers indicate a very high unmet need in FM (ranked ≥4.0 on a 5 - point scale) • Prescribers report there is no standard of c
Slide 31: Many Fibromyalgia Patients are Prescribed Off-Label Drugs
31 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Many Fibromyalgia Patients are Prescribed Off - Label Drugs; ~53% FM Patients Prescribed Opioids Off - Label 1,2 1.04% 6.03% 11.74% 12.96% 13.23% 17.58% 19.45% 20.47% 22.62% 25.50% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% Milnacipran Amitr
Slide 32: CNS Portfolio: Tonmya (TNX-102 SL) for Fibromyalgia
32 © 2024 Tonix Pharmaceuticals Holding Corp. PROFILE DEVELOPMENT PROGRAM Patents Issued CNS PORTFOLIO Tonmya (TNX - 102 SL): Fibromyalgia Cyclobenzaprine Protectic ® Sublingual Tablets Fibromyalgia (FM) is a chronic pain disorder resulting from amplified sensory and pain signaling within the CNS •
Slide 33: Planning for Tonmya Launch and Marketing
33 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Planning for Tonmya Launch and Marketing Several companies that successfully developed CNS drugs have launched them • Big Pharma wants the commercial launch de - risked before acquisition ( e.g. , Nurtec ®) To prepare for the launch of Tonm
Slide 34: Additional Potential Indications for Tonmya
34 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Additional Potential Indications for Tonmya (TNX - 102 SL) Fibromyalgia - Type Long COVID • Status: Phase 2 • Phase 2 study ( PREVAIL ) completed • Topline results reported 3Q 2023 Next Steps: Meet with FDA Acute Stress Reaction/ Acute Stre
Slide 35: Role of Infections in Triggering Fibromyalgia or CFS-Like Illnesses
35 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Role of Infections in Triggering Fibromyalgia or Chronic fatigue (CFS) - Like Illnesses Infection initiates an autoreactive process, which affects several functions, including brain and energy metabolism 2 - 7 • Infections can trigger any o
Slide 36: About Fibromyalgia-Type Long COVID
36 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO About Fibromyalgia - Type Long COVID Many Long - COVID symptoms overlap with core symptoms of fibromyalgia and are hallmarks of other chronic pain syndromes like myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) Multisite pain Mem
Slide 37: Phase 2 PREVAIL Study Design
37 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL for Fibromyalgia - Type Long COVID: Phase 2 PREVAIL Study Design Study c haracteristics: • Randomized, double - blind, placebo - controlle d study of TNX - 102 SL in fibromyalgia - type Long COVID • U.S. sites only, completed e
Slide 38: Phase 2 PREVAIL Topline Results
38 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: Phase 2 PREVAIL Topline Results 1 D id not meet the primary endpoint of multi - site pain reduction at W eek 14 However, f indings fulfill the objectives of proof - of - concept study, supporting the decision to advance the pr
Slide 39: Acute Stress Reaction / Acute Stress Disorder
39 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CNS PORTFOLIO Acute Stress Reaction (ASR) / Acute Stress Disorder (ASD) ASR/ASD are acute stress conditions resulting from trauma which c an affect both civilian and military populations. Large unmet need: • According to National Center for
Slide 40: TNX-102 SL for ASR/ASD: Program Status
40 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL for ASR/ASD: Program Status Status: Expect to start Phase 2 in 2Q 2024 ; received IND clearance from FDA Phase 2 Trial Funded by DoD grant to University of North Carolina (UNC) • UNC Institute for Trauma Recovery awarded a $3M
Slide 41: Phase 2 OASIS Study Design
41 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL for ASR/ASD: Phase 2 OASIS Study Design General s tudy c haracteristics: • Randomized, double - blind, placebo - controlle d study in Acute Stress Reaction (ASR) / Acute Stress Disorder (ASD) • The proposed O ptimizing A cute S
Slide 42: Tonmya Patents and Patent Applications
42 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tonmya (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
Slide 43: Tonix Medicines: Marketed Products
© 2024 Tonix Pharmaceuticals Holding Corp. TONIX MEDICINES: MARKETED PRODUCTS
Slide 44: Tonix Medicines: Commercial-Stage Specialty Pharma Subsidiary
44 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tonix Medicines: Commercial - Stage Specialty Pharma Subsidiary • Tonix Medicines is a w holly - owned subsidiary of Tonix ( NASDAQ: TNXP) • Currently marketing two products indicated for the treatment of acute migraine: Zembrace ® SymTouch
Slide 45: Two Marketed Proprietary Migraine Drugs
45 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Two Marketed Proprietary Migraine Drugs Non - oral Formulations of Sumatriptan • Each indicated for the tr eatment of acute migraine with or without aura in adults • Sumatriptan remains the acute migraine ‘gold standard’ treatment for many
Slide 46: Zembrace and Tosymra Bypass the GI Tract
46 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Zembrace and Tosymra Bypass the GI Tract Bypassing gastrointestinal (GI) tract is potential advantage for treating acute migraine • GI absorption may be inconsistent in migraineurs due to gastric stasis (also called “gastroparesis”) 1 - 4 •
Slide 47: Pipeline Programs and Strategy for Partnerships
47 © 2024 Tonix Pharmaceuticals Holding Corp. Pipeline Programs and Strategy for Partnerships
Slide 48: Pipeline Development Strategy
48 © 2024 Tonix Pharmaceuticals Holding Corp. Pipeline Development Strategy Focusing on government and academic collaborations • Validates Tonix’s scientific expertise and technology • Reduces internal spend • Increases number of trials • Potentially speeds tim e to market • Grants, contracts, cost
Slide 49: External Partnerships
49 © 2024 Tonix Pharmaceuticals Holding Corp. External Partnerships Government partners providing direct funding, cost sharing or in - kind support include: • National Institutes of Health (NIH) • National Institute of Allergy and Infectious Disease (NIAID) ▪ TNX - 1800 selected for Project NextGen
Slide 50: Key Partnerships
50 © 2024 Tonix Pharmaceuticals Holding Corp. TNX - 1300: COCAINE INTOXICATION Key Partnerships TNX - 1500: ALLOGRAFT REJECTION TNX - 1800 : COVID - 19 VACCINE TNX - 2900: PRADER - WILLI SYNDROME TNX - 102 SL: ACUTE STRESS DISORDER
Slide 51: TNX-2900 Intranasal Potentiated Oxytocin with Magnesium
51 © 2024 Tonix Pharmaceuticals Holding Corp. TNX - 2900 Intranasal Potentiated Oxytocin with Magnesium A n ovel, non - CGRP antagonist approach to treatment
Slide 52: TNX-2900: Novel Formulation of Intranasal Oxytocin Potentiated with Magnesium
TNX - 2900: Novel Formulation of Intranasal Oxytocin (OT) Potentiated with Magnesium 52 Magnesium is known to potentiate the binding of OT to its receptor 1 ,2 Key Differentiators © 2023 Tonix Pharmaceuticals Holding Corp. Oxytocin receptor Oxytocin o Targeted intranasal delivery • Low systemic expo
Slide 53: Rare Disease Portfolio: About Prader-Willi Syndrome
53 © 2024 Tonix Pharmaceuticals Holding Corp. RARE DISEASE PORTFOLIO Rare genetic diseas e that afflicts 10 - 20 thousand individuals in the US About Prader - Willi Syndrome Prader - Willi Syndrome (PWS) is the most common genetic cause of life - threatening childhood obesity. PWS causes unhealthy b
Slide 54: TNX-1300 Cocaine Esterase
54 © 2024 Tonix Pharmaceuticals Holding Corp. TNX - 1300 Cocaine Esterase Fast acting antidote for life threatening cocaine intoxication
Slide 55: TNX-1300: Recombinant Protein Rapidly Degrades Cocaine in the Bloodstream
TNX - 1300: Recombinant Protein Rapidly Degrades Cocaine in the Bloodstream 55 Drops plasma exposure by 90% in 2 minutes Key Differentiators © 2024 Tonix Pharmaceuticals Holding Corp. o Rapidly metabolizes cocaine within matter of minutes o N o other product currently on the market for this indicati
Slide 56: About Cocaine Intoxication
56 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CNS PORTFOLIO Over 500,000 emergency department visits for cocaine, annually 3,4 About Cocaine Intoxication Over 5 million Americans reported current cocaine use in 2020, which is almost 2% of the population 1 . In 2021, more than 24,900 in
Slide 57: Immunology: Key Candidates
© 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY: KEY CANDIDATES
Slide 58: TNX-1500 Anti-CD40L Monoclonal Antibody
58 © 2024 Tonix Pharmaceuticals Holding Corp. TNX - 1500 Anti - CD40L Monoclonal Antibody Next Generation mAb preserves efficacy without risk of thrombosis
Slide 59: TNX-1500: Next Generation anti-CD40L mAb
TNX - 1500: Next Generation anti - CD40L mAb 59 Re - engineered to better modulate the binding of Fc R and mitigate risk of thrombosis Clinical Stage of Phase 1 study completed Key Differentiators © 2024 Tonix Pharmaceuticals Holding Corp. Selectively Modified anti - CD40L AB Ruplizumab full Fab C
Slide 60: TNX-1500 Strategy and Status
60 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 Strategy and Status Third Indication (and beyond): Autoimmune Diseases ( e.g., Multiple Sclerosis, Sj ö gen’s Syndrome, Systemic Lupus Erythematosus) • These indications require large studies, but represent large target ma
Slide 61: TNX-1500 Preclinical Data and Publications
61 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 Preclinical Data and Publications Non - human Primate Kidney Allo - Transplantation • TNX - 1500 monotherapy consistently prevents kidney transplant rejection with n o thrombosis observed • April 2023 Publication: Lassiter
Slide 62: Anti-CD40L Headlines
62 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO ࢻ - CD40L Headlines • Mass General Hospital just transplanted a genetically engineered pig kidney into a living human 1 • Boston Globe, March 21, 2024 • Patient’s death announced May 11, 2024 2 • The patient was being treated with anti - CD
Slide 63: Anti-CD40L Headlines
63 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Anti - CD40L Headlines • Sanofi recently published their Phase 2 data on their frexalimab in multiple sclerosis in the the New England Journal of Medicine 1 • Sanofi projects its Fc - modified humanized anti - CD40L mAb frexalimab will exce
Slide 64: TNX-1700 Recombinant Trefoil Factor Family Member Fusion Protein
64 © 2024 Tonix Pharmaceuticals Holding Corp. TNX - 1700 Recombinant Trefoil Factor Family Member 2 (rTFF2 - HSA) Fusion Protein Targeting the toxic tumor micro - environment
Slide 65: TNX-1700: Fighting Cancer by Targeting the Tumor Micro-Environment
TNX - 1700: Fighting Cancer by Targeting the Tumor Micro - Environment 65 S uppresses myeloid - derived suppressor cells (MDSCs) and activates anti - cancer CD8+ T cells o Different MOA than checkpoint inhibitors o Potential synergy with anti - PD - 1 or anti - PD - L1 monoclonal antibodies Key Diff
Slide 66: About Gastric and Colorectal Cancer
66 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO People living with colorectal cancer in the US 2 About Gastric and Colorectal Cancer Gastric and colorectal cancer are both leading cancers in the US. C olorectal cancer is the 3 rd leading cause of cancer - related deaths in both me
Slide 67: Infectious Disease: Key Candidates
© 2024 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE: KEY CANDIDATES
Slide 68: Infectious Disease Portfolio: Antiviral Discovery Programs
68 © 2024 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Host - directed antiviral discovery programs • CD45 targeted therapeutics o Small molecule therapeutics that reduce endogenous levels of CD45, a protein tyrosine phosphatase o Reduction in CD45 protects against many viruses i
Slide 69: TNX-801 Live Virus Vaccine
69 © 2024 Tonix Pharmaceuticals Holding Corp. TNX - 801 Live Virus Vaccine Live virus vaccine platform with multitude of potential applications
Slide 70: TNX-801: Recombinant Pox Vaccine Platform Using Live Virus Technology
TNX - 801: Recombinant Pox Vaccine (RPV) Platform Using Live Virus Technology 70 C loned version of horsepox 1 purified from cell culture Key Differentiators © 2024 Tonix Pharmaceuticals Holding Corp. TNX - 801* (Horsepox) *TNX - 801 is in the pre - IND stage of development and has not been approved
Slide 71: Smallpox and Monkeypox
71 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Smallpox and Monkeypox • Smallpox has been eradicated, but fears of malicious reintroduction persist 1 - 2 ‒ Russia and North Korea have capabilities to weaponize smallpox ‒ The U.S. population is largely vaccine - naïve (under ~60 years ol
Slide 72: Monkeypox Outbreak Recent Headlines
72 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Monkeypox Outbreak Recent Headlines • Outbreak in the Congo ‒ NPR, April 2, 2024 1 • U.S. Bipartisan Commission on Biodefense (2024) 2 : ‒ “The shift of Mpox in Africa to the more lethal and sexually transmitted Clade I dictates that furthe
Slide 73: Monkeypox Headlines
73 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Monkeypox Headlines • Multiple recent statements by U.S. Agencies warning about smallpox and monkeypox 1 - 6 • U.S. National Academy of Sciences Consensus Report (March, 2024) 6 ‒ “Additionally, safer, single - dose vaccines and a diverse s
Slide 74: TNX-1800: Designed to Express the SARS-CoV-2 Spike Protein
74 © 2024 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO TNX - 1800: Designed to Express the SARs - CoV - 2 Spike Protein TNX - 1800 (recombinant horsepox virus) is a live virus vaccine based on Tonix’s TNX - 801 that is designed to express the spike protein of the SARS - CoV - 2 v
Slide 75: Team, Network, & Upcoming Milestones
© 2024 Tonix Pharmaceuticals Holding Corp. TEAM, NETWORK, & UPCOMING MILESTONES
Slide 76: Management Team
76 © 2024 Tonix Pharmaceuticals Holding Corp. Management Team Seth Lederman, MD Co - Founder, CEO & Chairman Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger, CPA Chief Financial Officer
Slide 77: Milestones: Recently Completed and Upcoming
77 © 2024 Tonix Pharmaceuticals Holding Corp. Milestones: Recently Completed and Upcoming x Tonmya Milestones Initiate Phase 2 study of TNX - 102 SL for acute stress disorder □ 2 nd Quarter 2024 Initiate Phase 2 study of TNX - 1300 for the treatment of cocaine intoxication □ 2 nd Quarter 2024 Other
Slide 78: Thank You
© 2024 Tonix Pharmaceuticals Holding Corp. THANK YOU
Slide 79: Zembrace Important Safety Information (1 of 2)
79 © 2024 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
Slide 80: Zembrace Important Safety Information (2 of 2)
80 © 2024 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 v
Slide 81: Tosymra Important Safety Information (1 of 2)
81 © 2024 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
Slide 82: Tosymra Important Safety Information (2 of 2)
82 © 2024 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,
Tonix Pharmaceuticals Holding — Investor Presentation (June 2024) on 6ix