Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (December 2024)
85 slides from Tonix Pharmaceuticals's investor presentation, Dec 3, 2024
Slide 1: Corporate Presentation December 2024
TONIX PHARMACEUTICALS Corporate Presentation December 2024 NASDAQ: TNXP Version PO6025 December 3, 2024 (Doc 1537)
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: Who We Are
Who We Are 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, and rare disease TONIX
Slide 4: CNS: Key Development Candidates
TONIX PHARMACEUTICALS CNS: KEY DEVELOPMENT CANDIDATES
Slide 5: Key Clinical Programs
Key Clinical Programs NDA Molecule’ Indication Phase 1 Phase 2 Phase 3 Submission Fibromyalgia Granted FDA Fast Track TNX-102 SL Designation Cyclobenzaprine HC! Sublingual Tablets Acute Stress Disorder udy™ Start fed 40°24 TNX-1300 Cocaine Intoxication Cocaine Esterase Granted! FDA Breakthrough NIDA
Slide 6: TNX-102 SL
TNX-102 SL* (Cyclobenzaprine HCI Sublingual Tablets) A unique, sublingual formulation of cyclobenzaprine designed to optimize delivery and absorption
Slide 7: Fibromyalgia is a Large, Underserved and Dissatisfied Population
Fibromyalgia is a Large, Underserved and Dissatisfied Population 9° = z * Serious Condition (U.S. FDA requirement for Fast Track Designation) 2 + More than 10 million U.S. adults are affected — predominantly women’? 3 — Debilitating and life altering condition 3 Sani a é 2 Significant economic impac
Slide 8: About Fibromyalgia
About Fibromyalgia Fibromyalgia is a chronic pain disorder resulting from amplified sensory and pain signaling within the CNS — now recognized as nociplastic pain'~* Fibromyalgia is a syndrome comprised of the symptoms: chronic widespread é pain, nonrestorative sleep, and fatigue a] t ; f Petigue &
Slide 9: The Third Primary Type of Pain: Nociplastic Pain
The Third Primary Type of Pain: Nociplastic Pain’> Nociplastic syndrome includes: (1) widespread pain (2) fatigue (3) sleep disturbances (4) cognitive dysfunction (“brain fog”) Examples: Fibromyalgia _ CFS/ ME* . th Long COVID Functionally “ ’. Migraine Appropriate Pain if ‘, Pcs* Acute \IBS** é cep
Slide 10: Poor Sleep and Pain have Bi-directional Reinforcing Effects
Poor Sleep and Pain have Bi-directional Reinforcing Effects’ + Poor sleep and pain form a vicious cycle in driving fibromyalgia decompensation * Can't sleep — worse pain / In pain > can’t sleep + Poor sleep and pain contribute to persistence, chronicity and severity + Syndrome includes symptoms of f
Slide 11: TNX-102 SL (Cyclobenzaprine HCI Sublingual Tablets)
TNX-102 SL (Cyclobenzaprine HCI Sublingual Tablets) * Non-opioid analgesic designed for long-term daily bedtime use in fibromyalgia patients - Targets non-restorative sleep — Potent binding and antagonist activities at four post-synaptic receptors ‘ — serotonin-5-HT2A ‘ O0M04LYOd SND — at-adrenergic
Slide 12: TNX-102 SL: Sublingual Administration and Transmucosal Delivery
TNX-102 SL: Sublingual Administration and Transmucosal Delivery + Advantages of the sublingual route + Faster absorption provides PK that is ideal for bedtime dosing * Bypasses “first-pass” hepatic metabolism + Reduced metabolism of parent CBP to active metabolite norcyclobenzaprine (nCBP) OM04LYOd
Slide 13: TNX-102 SL for FM: Non-opioid, Centrally-Acting Analgesic
TNX-102 SL for FM: Non-opioid, Cent Potentially Transformative Approach Potent binding and antagonist activities at four key *TNX102 SL has not boon approved for any ndcaton, ‘rya102 Sie an investigational new drug, efty and efcacyhas not been establhed and thas not been approved or any ination, ral
Slide 14: Fibromyalgia is Believed to Result from Chronic Pain or Prior Stresses
Fibromyalgi Stress Experiences The pain system evolved to detect acute pain + The body's “check engine” light Chronic pain breaks down the system that determines whether a sensory experience is painful * Chronic pain results in nociplastic syndromes + Nociplastic syndrome was formerly known as “Cent
Slide 15: Common Chronic Conditions are a Challenge for Pharma
Common Chronic Conditions are a Challenge for Pharma Fibromyalgia is a common chronic disease’ * Chronic pain syndrome that persists for years or decades No animal model is recognized for nociplastic syndromes or its component symptoms + Widespread pain + Fatigue * Sleep disturbance * Cognitive impa
Slide 16: Common Chronic Conditions are a Challenge for Society
Common Chronic Conditions are a Challenge for Society pain The epidemic of prescription pain killers was addressed by regulations which limited the availability of opioids Many individuals who are opioid dependent have transitioned to illegal street heroin and fentanyl Illegal drugs contribute to ho
Slide 17: Current FDA-Approved Fibromyalgia Drugs
Current FDA-Approved Fibromyalgia Drugs’ 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) - Lilly Savell
Slide 18: Fibromyalgia Program Status
Fibromyalgia Program Status ° = ee Zz 6 TNX-102 SL 3 Cyclobenzaprine Sublingual Fibromyalgia NDA Submitted to FDA in October 2024 2 Tablets nn . > First pivotal Phase 3 study (RELIEF) reported — December 2020' yt “> Second Phase 3 study (RALLY) missed primary endpoint - July 2021 x > Confirmatory pi
Slide 19: TNX-102 SL: Phase 3 RESILIENT Study Design
TNX-102 SL: Phase 3 RESILIENT Study Design General study characteristics: + Randomized, double-blind, multicenter, placebo-controlled study in fibromyalgia + 33U,S. sites enrolled 457 participants with fibromyalgia as defined by 2016 Revisions to the 2010/2011 FM Diagnostic Criteria’ J 1O04LYOd SND.
Slide 20: RESILIENT Primary Outcome Measure
RESILIENT Primary Outcome Measure 5) RESILIENT Reduction in Widespread Pain Study Weekly Average of Daily Diary NRS Ratings of Average Pain Over Prior 24 Hours ° —*-Placebo (N=225) a-TNX-102 SL (N=231) & 8 104LHOd SND && be ® RRS LS Mean (SE) Change in NRS Pain Score 2 *p<0.01; **p<0.001; ***p<0.000
Slide 21: Summary of Key Pre-Specified Secondary Outcome Measures
Summary of Key Pre-Specified Secondary Outcome Measures 3 6 Rating Scale Week 14 Met** . Patient Global Impression of Change (PGIC) p<0.001 va 3 Fibromyalgia Impact Questionnaire - Symptoms p<0.001 v ; . . 2 Fibromyalgia Impact Questionnaire - Function p=0.001 v ’ PROMIS Sleep Disturbance p<0.001 v
Slide 22: RESILIENT: CSFQ-14 Females
RESILIENT: CSFQ-14 Females 5) RESILIENT Pre-specified exploratory endpoint Study is} ao Changes in Sexual Functioning Questionnaire Changes in Sexual Functioning UD Change from Baseline to Week 14 LsMeanDiference (95501) Questionnaire short form (CSFQ-14) was a eS) (PBO/TNx S.¢me) safety measure in
Slide 23: RESILIENT Pre-Specified Primary Endpoint Summary
wy 7) RESILIENT RESILIENT Pre-Specified Primary Endpoint Study Summary' + 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 Additional Findings + Effect size 0.38 + All pre-specifi
Slide 24: RESILIENT Safety Summary
NV RESILIENT Ay s Study RESILIENT Safety Summary Among participants randomized to TNX-102 SL and to placebo, 81.0% and 79.6%, respectively, completed the study ‘TNX-102 SL was generally well tolerated with an adverse event (AE) profile comparable to prior fibromyalgia studies + No new safety signals
Slide 25: RESILIENT Safety Summary: Adverse Events
2 @ 7 RESILIENT RESILIENT Safety Summary Study 9 Go zu Treatment-Emergent Adverse Events (TEAEs) 2 at Rate of 2 3% in Either Treatment Group’ et fe) System Organ Class ‘TNX-102 SL Placebo Total* i [= Preferred Term N=231 N=226 N=457 id © Systemic Adverse Events “A " COVID-19 10 (4.39%) 7 (3.1%) 17 (
Slide 26: TNX-102 SL Showed Activity on Pain, Sleep and Fatigue
TNX-102 SL Showed Activity on Pain, Sleep and Fatigue and was Generally Well Tolerated in the RESILIENT Study’ Drug initial indication of active ingredient | [I Tespererars Class Mechanism ‘Antagonist at 4 post-synaptic receptors? Fibromyalgia Activity — Tolerability Issues Oral administration site
Slide 27: ~50% of U.S. Fibromyalgia Patients are on Medicare
~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 Fibromyalgia Patients by Coverage’ on Medicare ~ EVERSANA analysis of claims database . . . consisting of 2.2M patients, for whic
Slide 28: Prescribers Expressed Broad Dissatisfaction with Available Medications
Prescribers Interviewed Expressed Broad Dissatisfaction with Available Fibromyalgia Medications: Results of Primary Research’ on FM Therapi Drug Positives Negatives Duloxetine (Cymbalta, generic) + Relatively high efficacy compared to alternatives) Can be titrated slowly from 20mg to 120mg Tolerabil
Slide 29: Opportunity for a New, Unique Fibromyalgia Treatment Option
Opportunity for a New, Unique Fibromyalgia Treatment Option: Results of Primary Research from EVERSANA™” Prescribers indicate a very high unmet need in FM (ranked 24.0 on a 5-point scale) Prescribers report there is no standard of care in FM, employ an individualized approach based on symptomology +
Slide 30: Many Fibromyalgia Patients are Prescribed Off-Label Drugs
50% 4556 40% 35% 20% 25% 20% 15% 10% 5% 0% Many Fibromyalgia Patients are Prescribed Off-Label Drugs; ~53% FM Patients Prescribed Opioids Off-Label' % FM Patients (after index? date) FDA Approved 1.08% Minacipran + 2022-2023 EVERSANA analysis of dams database, May 2028; commissioned by Tonk Oft-Labe
Slide 31: Planning for TNX-102 SL Launch and Marketing
Planning for TNX-102 SL 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®) Mkt FDA $3.5B Auvelity® Depression fe) Zz G v ° a a a fe) FS Biohaven BHVN $3.0B_ Nurtec® Migr
Slide 32: Acute Stress Reaction (ASR) / Acute Stress Disorder (ASD)
& ___ Acute Stress Reaction (ASR) / Acute Stress Disorder (ASD) ASR/ASD are acute stress conditions resulting from trauma which can affect both civilian and military populations. O0M04LYOd SND Large unmet need: i + According to National Center for PTSD, about 60% of men and 50% of women in the US ar
Slide 33: TNX-102 SL for ASR/ASD: Program Status
TNX-102 SL for ASR/ASD: Program Status Status: Expect to start investigator-initiated Phase 2 in 1Q 2025; received IND clearance from FDA Investigator-initiated Phase 2 Trial Funded by DoD grant to University of North Carolina (UNC) + UNC Institute for Trauma Recovery awarded a $3M grant from the De
Slide 34: TNX-102 SL for ASR/ASD: Phase 2 OASIS Study Design
TNX-102 SL for ASR/ASD: Phase 2 OASIS Study Design General study characteristics: Randomized, double-blind, placebo-controlled study in Acute Stress Reaction (ASR) / Acute Stress Disorder (ASD) + The proposed Optimizing Acute Stress reaction Interventions with TNX-102 SL (OASIS) trial will examine t
Slide 35: Significant Overlap between Fibromyalgia and Long-COVID
Significant Overlap between Fibromyalgia and Long-COVID National Institutes of Health (NIH)-sponsored RECOVER study found many Long COVID patients suffer from pain at multiple sites* + Suggests that many Long-COVID patients may meet the diagnostic criteria for fibromyalgia ‘4 O0M04LYOd SND _ Tonix h
Slide 36: NASEM Definition of Long-COVID
NASEM Definition of Long-COVID * In June 2024, the US National Academies of Sciences, Engineering and Medicine (NASEM) described fibromyalgia as a ‘diagnosable condition’ in people suffering from Long COVID* + This definition provides guidance to government, healthcare professionals and industry tha
Slide 37: TNX-102 SL: Patents and Patent Applications
TNX-102 SL: Patents and Patent Applications + U.S. Composition:* + A75:25 cyclobenzaprine HCI - mannitol eutectic (dependent claims add a basifying agent). + 5 US Patents (Expire November 2034) + 4 Pending US Applecation (Would expire November 2034) + Acompositon ofa cyclobenzaprine HCl and a basiyi
Slide 38: Tonix Medicines: Marketed Products
TONIX MEDICINES: MARKETED PRODUCTS
Slide 39: Tonix Medicines: Commercial-Stage Specialty Pharma Subsidiary
Tonix Medicines: Commercial-Stage Specialty Pharma Subsidiary * 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 at O0M04LYOd SND
Slide 40: Tonix Medicines Markets Two Proprietary Migraine Drugs
Tonix Medicines Markets Two Proprietary Migraine Drugs Non-oral Formulations of Sumatriptan iy oO Zembrace® SymTouch® + Each indicated for the treatment of acute migraine with or without aura in adults uv (sumatriptan injection) 3 mg! + Sumatriptan remains the acute migraine ‘gold standard’ treatmen
Slide 41: Zembrace and Tosymra Bypass the GI Tract
Zembrace and Tosymra Bypass the GI Tract Bypassing gastrointestinal (Gl) tract is potential advantage for treating acute migraine + Glabsorption may be inconsistent in migraineurs due to gastric stasis (also called “gastroparesis”)'4 * Nausea and vomiting are symptoms of migraine5 which can complica
Slide 42: Pipeline: Programs and Strategy for Partnerships
Pipeline Programs and Strategy for Partnerships TONIX ©
Slide 43: Pipeline Development Strategy
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 time to market Grants, contracts, cost-sharing or “in-kind” arrangements * TONIX ill (© 2024 Ton
Slide 44: External Partnerships
External Partnerships Government partners providing direct funding, cost sharing or ii * National Institutes of Health (NIH) * National Institute of Allergy and Infectious Disease (NIAID) = TNX-1800 selected for Project NextGen eg ' * National Institute on Drug Abuse (NIDA) i. _ = TNX-1300 for cocai
Slide 45: Key Partnerships
Key Partnerships TNX-1500: ALLOGRAFT REJECTION TNX-1300: COCAINE INTOXICATION ecw, USsvaRe - nf Natona! nstito ‘on Brug Abuse TNX-102 SL: ACUTE STRESS DISORDER TNX-1800: COVID-19 VACCINE artment of Defense iT oe National Institute of QD sovrensoine A | PEER = ps foment sa ‘TNX-2900: PRADER-WILLI SYN
Slide 46: TNX-801 Live Virus Vaccine
TNX-801 Live Virus Vaccine Live virus vaccine platform with multitude of potential applications TONIX °
Slide 47: Mpox Declared Public Health Emergency of International Concern
Mpox Declared Public Health Emergency of International Concern . (PHEIC) by WHO* on August 14, 2024: New Clade | = “Clade Ib” ° Clade Ib - first wave in Democratic Republic of Congo (DRC) Affects children + New mutations ~0.5% mortality Affects both MSM (men who have sex with men) + heterosexual tra
Slide 48: Mpox Outbreak 2022-23: Clade IIb
es) Mpox Outbreak 2022-23: Clade IIb " Public Health Emergency Global Health Concern Risk of Spread and Lethality of Clade IIb + Case Fatality Rate (CFR): 0.1% to 3.6%->Lower compared to Clade | + Primarily spread through sexual contact among MSM (men who have sex with men) + Rapid and significant s
Slide 49: Monkeypox Headlines
Monkeypox Headlines * Multiple recent statements by U.S. Agencies warning about smallpox and monkeypox'® * U.S. National Academy of Sciences Consensus Report (March, 2024)® “Additionally, safer, single-dose vaccines and a diverse set of therapeutic options against smallpox would improve the U.S. rea
Slide 50: Cloned version of horsepox purified from cell culture
Cloned version of horsepox' purified from cell culture TNT ANTIGEN Horsepox; Vaccini Horsepox Future Pandemics & New eee) ee a CODING Infectious Diseases Biodefense Key Differentiators — —_— — Oncology Live virus vaccines are the most established vaccine technology Prevents forward transmission ©. E
Slide 51: TNX-801: Pre-IND Ready Candidate Mpox Vaccine
@ TNX-801: Pre-IND Ready Candidate Mpox Vaccine + Based on synthetic horsepox-vector, believed related to first smallpox vaccine used by Dr. Edward Jenner in 1796" * Single-dose percutaneous? + Attenuated live virus® + Expected durable T-cell immunity similar to 19"" Century vaccinia * Believed to b
Slide 52: Illustrative Safety Spectrum of Pox-based Vaccine Vectors
Illustrative Safety Spectrum Of Pox-based Vaccine Vectors as Live Virus Vaccines Non-replicating Minimally replicating Robustly replicating vaccines vaccines vaccines c 20° Century smallpox ’ ( MVA Live horsepox, vaccines al : Canarypox } _ Recombinant Fowlbox | Poxvirus Vaccine Dryvax Copenhagen |
Slide 53: TNX-801: Immunogenicity and Efficacy in Animals — Study Design
TNX-801: Immunogenicity and Efficacy in Animals — Study Design Vaccination Challenge : Dose F Dose Group Vaccine (Logio PFU) Route Virus (L09jo PFU) Route il Wee 4 6.6 Percutaneous 2 oer 4 5.7 Percutaneous | mpxv (Zaire) 5.0 lg i) rVACV* 4 5.0 Percutaneous | Clade Ia 4 Mock 4 - Percutaneous Seanfeat
Slide 54: TNX-801 Vaccination: Immunogenicity Total IgG
TNX-801 Vaccination — Followed by Lethal Monkeypox Clade | Challenge, Immunogenicity: Immunogenicity: Total IgG (ELISA) 1600 + + P 7 m 2 1200 4y ¥y 1, ' * - 1 TNX-801 (HD) Py, << 300 TNX-801 (LD) j s * 7 Drvacv Sm | os hd 0 a ene the. Md. Pee i & 100% Seroconversion in Baseline 28 56 TNX-801 vaccina
Slide 55: TNX-801 Vaccination: Neutralizing Antibody Assay
TNX-801 Vaccination — Followed by Lethal Monkeypox Clade | Challenge, Immunogenicity: Neutralizing Antibody (PRNT;) Assay) _ I TNX-801 (HD) I TNX-801 (LD) Oi rvacv Ol Mock 640. 4 . $ I it g 160. Py = e 3 40. B 10 tei-/e}- let le a a 3 28 56 Days Post Vaccination 100% Seroconversion and 88% of TNX-80
Slide 56: TNX-801 Vaccination: Clinical Signs (Lesions)
TNX-801 Vaccination — Followed by Lethal Monkeypox Clade | Challenge, Clinical Signs (Lesions) TCAD High Dose TRA Law Geos > 16544 2 > 16546 Srems 3 iesa0 ™@ TNX-801 (HD) tos tssr H Zien =, x ters “i TNX-801 (LD) H H a rvacv 3" a" HE Mock o 7 % a 2B . 7 ume i Days post MPXV challenge Days post MPXV
Slide 57: TNX-801 Vaccination: Lethality
TNX-801 Vaccination — Followed by Lethal Monkeypox Clade | Challenge, Clinical Disease: Lethality Ss S 100 5 7 n < 50: o = TNX-801 (High) Q 25 “ NX801 (Low) o =e rVACV a 0. == _Mock 0 3 6 9 12 15 18 21 24 27 30 Time (dpi) 100% survival in TNX-801 vaccinated ~ animals ia departs mes fa so TONIX (© 20
Slide 58: Infectious Disease: Key Candidates
TONIX PHARMACEUTICALS INFECTIOUS DISEASE: KEY CANDIDATES
Slide 59: Broad-Spectrum Antiviral Discovery Programs
Broad-Spectrum Antiviral Discovery Programs | Host-directed antiviral discovery programs J + TNX-4200*: CD45 targeted therapeutics o Small molecule therapeutics that reduce endogenous levels of CD45, a protein tyrosine phosphatase ° Reduction in CD45 protects against many viruses including the Ebola
Slide 60: U.S. Department of Defense
) USS. Department of Defense Tonix Awarded Contract from DoD Defense Threat Reduction Agency (DTRA) contract is expected to advance development of Tonix’s broad-spectrum oral antiviral program, TNX-4200, for medical countermeasures * Other Transaction Agreement (OTA) with a potential for up to $34 m
Slide 61: TNX-2900
TNX-2900 Intranasal Potentiated Oxytocin with Magnesium A novel, non-CGRP antagonist approach to treatment TONIX »
Slide 62: Magnesium is known to potentiate the binding of OT to its receptor
Magnesium is known to potentiate the binding of OT to its receptor’? ~ k Oxytocin receptor Oxytocin x Key Differentiators o Targeted intranasal delivery + Low systemic exposure ae o When delivered via the nasal route, concentrates in 4 trigeminal system * Binding of OT to receptors on neurons in tri
Slide 63: About Prader-Willi Syndrome
About Prader-Willi Syndrome Prader-Willi Syndrome (PWS) is the most common genetic cause of life-threatening childhood obesity. PWS causes unhealthy behaviors around food’, consequences such as obesity, type 2 diabetes, and cardiovascular disease’, and creates significant caretaker burden™4 1 0-20 R
Slide 64: TNX-1300
TNX-1300 Cocaine Esterase Fast acting antidote for life threatening cocaine intoxication TONIX *
Slide 65: Drops plasma exposure by 90% in minutes
Drops plasma exposure by 90% in 2 minutes CocE Cocaine Key Differentiators o Rapidly metabolizes cocaine within matter of minutes o No other product currently on the market for this indication (© 2024 Tonix Pharmaceuticals Holding Corp, FDA Breakthrough Therapy Designation Awarded Cooperative Agreem
Slide 66: About Cocaine Intoxication
@ ___ About Cocaine Intoxication Over 5 million Americans reported current cocaine use in 2020, which is almost 2% of the population’. In 2021, more than 24,900 individuals in the US died from drug overdose deaths involving cocaine? OM04LYOd SND 500k Over 500,000 emergency department visits for coca
Slide 67: Immunology: Key Candidates
TONIX PHARMACEUTICALS IMMUNOLOGY: KEY CANDIDATES
Slide 68: TNX-1500
TNX-1500 Anti-CD40L Monoclonal Antibody Next Generation mAb preserves efficacy without risk of thrombosis TONIX »
Slide 69: Re-engineered to better modulate the binding of FcyR
Re-engineered to better modulate the binding of FcyR and mitigate risk of thrombosis Clinical Stage of Phase 1 study completed Key Differentiators Expected to deliver efficacy without compromising safety First Generation: Development halted due to ee Sy Y C thromboembolic (TE) complications—blood cl
Slide 70: TNX-1500 Strategy and Status
2 Gis TNX-1500 Strategy and Status 4) Proposed Initial Indication: Prevention of Allograft Rejection Status: Clinical stage Phase 1 complete Collaborations ongoing with Mass General Hospital on heart and kidney transplantation in non-human primates + Collaboration with Boston Children’s on bone marr
Slide 71: TNX-1500 Preclinical Data and Publications
TNX-1500 Preclinical Data and Publications Non-human Primate Kidney Allo-Transplantation + TNX-1500 monotherapy consistently prevents kidney transplant rejection with no thrombosis observed + April 2023 Publication: Lassiter, G., et al. (2023). TNX-1500, an Fo-modified Anti-CD154 Antibody, Prolongs
Slide 72: a-CD40L Headlines
a-CD40L Headlines + Mass General Hospital just transplanted a genetically engineered pig kidney into a living human‘ + Boston Globe, March 21, 2024 + Patient's death announced May 11, 2024? + The patient was being treated with anti- CD40L mAb tegoprubart from Eledon* + Massachusetts General Hospital
Slide 73: Anti-CD40L Headlines
Anti-CD40L Headlines + Sanofi recently published their Phase 2 data on their frexalimab in multiple sclerosis in the the New England Journal of Medicine’ * Sanofi projects its Fc-modified humanized anti-CD40L mAb frexalimab will exceed €5 B per year in peak sales? * Like frexalimab, TNX-1500 is Fc-m
Slide 74: TNX-1700
TNX-1700 Recombinant Trefoil Factor Family Member 2 (rTFF2-HSA) Fusion Protein Targeting the toxic tumor micro-environment TONIX *
Slide 75: TNX-1700: Fighting Cancer by Targeting the Tumor Micro-Environment
TNX-1700: Fighting Cancer by Targeting the Tumor Micro-Environment Suppresses myeloid-derived suppressor cells (MDSCs) and activates anti-cancer CD8+ T cells TFF2 Key Differentiators o Different MOA than checkpoint inhibitors o Potential synergy with anti-PD-1 or anti-PD-L1 monoclonal antibodies Pre
Slide 76: mTNX-1700 Showed Synergy with anti-PD1 Antibody
mTNX-1700 (mTFF2-MSA) Showed Synergy with anti-PD1 Antibody in Inhibition of s.c. ACKP Xenograft Growth in Animals A Vehicle ACKP Day 0 lat s Day 10 TFF2-MSA Day 28h s.c. inoculation Start treatment PD-1 Antibody Jay 28 Terminate at volume 150-200 mm? ‘Combination °xPeriment and extract ip. every 3
Slide 77: About Gastric and Colorectal Cancer
About Gastric and Colorectal Cancer Gastric and colorectal cancer are both leading cancers in the US. Colorectal cancer is the 3 leading cause of cancer-related deaths in both men and women." > 1. 3M People living with colorectal cancer in the US? > 1 25k People living with gastric cancer in the US?
Slide 78: Team, Network, & Upcoming Milestones
TONIX PHARMACEUTICALS TEAM, NETWORK, & UPCOMING MILESTONES *8@ey N
Slide 79: Management Team
Management Team Seth Lederman, MD TARGENT~ :Fusilev" " Co-Founder, CEO & Chairman E Fusiey _vela... af a= Gregory Sullivan, MD Contain Unrviiaet New York State P i Chief Medical Officer snr area of Fopedlatsy- Psychiatric Institute Bradley Saenger, CPA . A Chief Financial Officer Ghire — vefttex Jes
Slide 80: Milestones: Recently Completed and Upcoming
Milestones: Recently Completed and Upcoming INX-102 SL for the Management of Fibromyalgia Milestones @4' Quarter 2023 Statistically significant topline results of Phase 3 RESILIENT study — 2"4 statistically significant Phase 2 trial e 2" Quarter 2024 Type B CMC and clinical pre-NDA meetings with FDA
Slide 81: Slide 81
Slide 82: Slide 82
Slide 83: Thank You
Slide 84: Zembrace Important Safety Information (1 of 2)
Slide 85: Zembrace Important Safety Information (2 of 2)
Tonix Pharmaceuticals Holding — Investor Presentation (December 2024) on 6ix