Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (September 2026)
44 slides from Tonix Pharmaceuticals's investor presentation, Sep 28, 2026
Slide 1: Investor Presentation October 2026
Investor Presentation October 2026 NASDAQ: TNXP PO6166 Sept 28, 2026 1683 © 2026 Tonix Pharmaceuticals Holding Corp. © 2026 Tonix Pharmaceuticals Holding Corp.
Slide 2: Cautionary Note on Forward-Looking Statements
Cautionary Note on Forward-Looking Statements Certain statements in this presentation are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “e
Slide 3: Innovating to Address Major Unmet Needs With Large Commercial Potential
Innovating to Address Major Unmet Needs With Large Commercial Potential Tonix is a commercial-stage biopharmaceutical company committed to solving complex, chronic, and sometimes invisible conditions Commercial Execution Lyme Disease Human mAb Curated Pipeline Prioritizing • Launched Nov. 17, 2025 •
Slide 4: Delivering CNS Medicines to Patients Through Our Commercial Portfolio
Delivering CNS Medicines to Patients Through Our Commercial Portfolio Discovered, developed, and launched the first treatment for fibromyalgia in over 15 years Created Tonix’s commercial infrastructure through a strategic acquisition of migraine products FIBROMYALGIA MIGRAINE MIGRAINE $13.5M total n
Slide 5: Advancing High-Potential Clinical Programs
Advancing High-Potential Clinical Programs Curated pipeline of potentially best- or first-in-class candidates intended to address significant and overlapping unmet medical needs for patients with CNS, infectious disease, and immunology conditions Core Clinical Development Programs* NAME LEAD INDICAT
Slide 6: TONMYA: Uniquely Designed to Treat Fibromyalgia
TONMYA: Uniquely Designed to Treat Fibromyalgia © 2026 Tonix Pharmaceuticals Holding Corp. © 2026 Tonix Pharmaceuticals Holding Corp.
Slide 7: TONMYA Targets a Large, Dissatisfied, and Underserved Population
TONMYA Targets a Large, Dissatisfied, and Underserved Population About Fibromyalgia Patients Healthcare Providers • Chronic pain disorder • Results from amplified sensory and pain signaling in the CNS • More than 10 million • ~15 million prescriptions • Core symptoms: chronic widespread patients in
Slide 8: Path to Delivering 1st Approved Treatment for Fibromyalgia in >15 Years
Path to Delivering 1st Approved Treatment for Fibromyalgia in >15 Years May 2026 July 2026 2016 2019-2023 Aug 2025 Revised ACR 1st Commercial 1 Managed st Tonix Runs 3 FDA Approval10 Coverage Medicare Guidelines4: Ph. 3 Studies Fibromyalgia Not Agreement11 Agreement13 with ~1,000 a Diagnosis of Pati
Slide 9: Delivering Much-Needed Innovation for the Treatment of Fibromyalgia
Delivering Much-Needed Innovation for the Treatment of Fibromyalgia First-in-class, first-line, non-opioid medicine approved for the treatment of fibromyalgia in adults; designed for bedtime administration and long-term use Patent-protected eutectic formulation1 to provide the first and only subling
Slide 10: TONMYA is Distinct From Other Therapies and Oral Cyclobenzaprine
TONMYA is Distinct From Other Therapies and Oral Cyclobenzaprine Tonix designed a unique, sublingual, proprietary formulation of cyclobenzaprine HCI intended to optimize efficacy, tolerability, delivery, and absorption Other Treatment Options Non-opioid analgesic designed for long-term, × High rat
Slide 11: High Rates of Opioid Use Despite Lacking Evidence of Effectiveness in Fibromyalgia
High Rates of Opioid Use Despite Lacking Evidence of Effectiveness in Fibromyalgia1,2 Off-label opioids are commonly prescribed within 18 months of fibromyalgia diagnosis3 Nociplastic pain conditions such as fibromyalgia are not responsive to opioid therapy4,5,6 Long-term opioid use may worsen pain
Slide 12: Patient and HCP Dissatisfaction has Led to Significant Off-label Use
Patient and HCP Dissatisfaction has Led to Significant Off-label Use Opioids are Commonly Prescribed within 18 Months of Fibromyalgia Diagnosis CBP, cyclobenzaprine; NSAID, nonsteroidal anti-inflammatory drug; SNRI, serotonin norepinephrine reuptake inhibitor; TCA, tricyclic antidepressant. Eversana
Slide 13: Growing Momentum for TONMYA: Net Sales and Key Metrics
Growing Momentum for TONMYA: Net Sales and Key Metrics Reflects strategic execution and value of TONMYA as the first approved treatment for fibromyalgia in 15+ years; first-line, non-opioid, designed for daily bedtime, long-term use 2Q Net Sales 2Q Key Metrics QoQ Growth ~$11M Prescriptions 100% 12,
Slide 14: Focused on Driving Uptake With Highly Targeted, Multi-Strategy Approach
Focused on Driving Uptake With Highly Targeted, Multi-Strategy Approach TONMYA has 100% share of voice as the only marketed fibromyalgia prescription drug1 Data-Driven HCP Targeting Experienced Sales Team • ~5% of 470K fibromyalgia diagnosing HCPs write ~70% of • ~150 TONMYA reps2 in the field presc
Slide 15: Omnichannel Marketing Campaigns and Messaging Building Brand Awareness
Omnichannel Marketing Campaigns and Messaging Building Brand Awareness and Activation Among Target Audiences Summary of Branded Ecosystems Patients • Welcome kit • Digital media • Influencer program • Website • Paid search • Social ads • Patient testimonials • AI optimization HCPs • KOL programs • W
Slide 16: TONMYA Together Provides Robust Patient Access and Support Services
TONMYA TogetherTM Provides Robust Patient Access and Support Services1 We are committed to offering product support to appropriate patients and their HCPs Payer Education and Engagement Digital Pharmacy Experience Traditional Pharmacy Savings Program • Total coverage: ~166M covered • Bridge programs
Slide 17: Tonix Created TONMYA's Formulation to Deliver the Tertiary Amine Tricyclic by Transmucosal Absorption
Tonix Created TONMYA’s Formulation to Deliver the Tertiary Amine Tricyclic by Transmucosal Absorption, Bypassing First-Pass Liver Metabolism The sublingual tablet rapidly disintegrates, dissolves, and TONMYA is administered Sublingual CBP enters the releases solubilized cyclobenzaprine (“CBP”) into
Slide 18: TNX-102 SL: Proprietary Eutectic Formulation
TNX-102 SL: Proprietary Eutectic Formulation 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 (K2HPO4) free bas
Slide 19: FDA Approval Based on Studies that Demonstrated Durable Improvement in Pain Intensity Scores
FDA Approval Based on Studies that Demonstrated Durable Improvement in Pain Intensity Scores in Fibromyalgia Patients Primary Efficacy Endpoint: Mean Change from Baseline in Weekly Average of Daily 24-Hour Recall Pain Intensity Scores at Week 14 in Adult Subjects with Fibromyalgia (Studies 1 and 3)
Slide 20: Approval Based on Studies that Demonstrated Significant Improvement in Pain Intensity Scores
Approval Based on Studies that Demonstrated Significant Improvement in Pain Intensity Scores in Fibromyalgia Patients Pivotal Studies Included in Label Demonstrate Statistically Significant Mean Change from Baseline in Weekly Average of Daily 24-hour Recall Pain Intensity Scores at Week 14 Study 1 (
Slide 21: Greater Percentage of Study Participants Taking TONMYA Experienced Clinically Meaningful Improvement
Greater Percentage of Study Participants Taking TONMYA Experienced a Clinically Meaningful (≥30%) Improvement in their Pain after Three Months, Compared to Placebo Study 1 (RELIEF)* Study 3 (RESILIENT)* n=503 n=457 100 100 Placebo TONMYA Placebo TONMYA 90 90 30% Responders 30% Responders 80 80 (47%
Slide 22: Generally Well-Tolerated with an Established Safety Profile
Generally Well-Tolerated with an Established Safety Profile In Clinical Studies • The most common adverse reactions • Pregnancy testing recommended in females (incidence ≥2% and at a higher incidence in with reproductive potential TONMYA-treated patients compared to • Concomitant use of TONMYA with
Slide 23: Core Mid-Stage Clinical Development Pipeline
Core Mid-Stage Clinical Development Pipeline © 2026 Tonix Pharmaceuticals Holding Corp. © 2026 Tonix Pharmaceuticals Holding Corp.
Slide 24: TNX-102 SL Potential Label Extension: Major Depressive Disorder (MDD)
TNX-102 SL1 Potential Label Extension: Major Depressive Disorder (MDD) TNX-102 SL Overview MOA • Potentially first-in-class for targeting the disturbed • Unique pharmacological profile of TNX-102 SL is designed to sleep associated with depression target the disturbed sleep (often associated with dep
Slide 25: TNX-102 SL: Uniquely Designed to Target Disturbed Sleep Quality in MDD
TNX-102 SL: Uniquely Designed to Target Disturbed Sleep Quality, a Novel Approach for Treating Major Depressive Disorder TNX-102 SL demonstrated preliminary encouraging signals in prior Tonix-led Phase 2 and Phase 3 studies that it could potentially improve subjective sleep quality and reduce depres
Slide 26: TNX-102 SL Potential Label Extension: Acute Stress Disorder/Acute Stress Reaction
TNX-102 SL1 Potential Label Extension: Acute Stress Disorder (ASD)/Acute Stress Reaction (ASR) Phase 2 OASIS Investigator-Initiated Study Overview About ASD/ASR $40M AURORA initiative, a national research program • Acute stress conditions resulting from trauma which can affect to improve the underst
Slide 27: TNX-4800: Phase 2-Ready, Intended to Address a Major Unmet Need in the U.S.
TNX-48001: Phase 2-Ready, Intended to Address a Major Unmet Need and Public Health Challenge in the U.S. TNX-48001 Overview Long-acting borreliacidal, human monoclonal Unmet Need antibody (mAb) with an engineered Fc Domain for • No currently marketed U.S. FDA-approved vaccines or an extended half-li
Slide 28: Anti-OspA Monoclonal Antibody (TNX-4800) Blocks B. burgdorferi Transmission
Circulating Anti-OspA Monoclonal Antibody (TNX-4800) Ingested by Tick Blocks B. burgdorferi Transmission From Tick to Human1 INFECTIOUS DISEASE PORTFOLIO OspA Midgut Adherence • TNX-4800 is a human monoclonal antibody against OspA1 B. burgdorferi Host can’t migrate to • TNX-4800 is designed to kill
Slide 29: Potential Advantages of TNX-4800 Relative to Vaccines in Development
Potential Advantages of TNX-4800 Relative to Vaccines in Development INFECTIOUS DISEASE PORTFOLIO TNX-4800 TNX-4800 VLA15 mRNA-1975 mRNA-1982 Sponsor Tonix Pfizer/Valneva Moderna Moderna Provides protection Status Phase 2 ready Phase 3 Phase 1/2 Phase 1/2 within two days after one dose Type Monocl
Slide 30: Phase 1 Clinical Study Summary Results
Phase 1 Clinical Study Summary Results TNX-4800 was studied in randomized, double-blind, sequential dose- escalation study (NCT04863287) to evaluate its safety, tolerability, pharmacokinetics, and immunogenicity • 44 healthy adult subjects randomized and 41 • Mean half-life ranged from 62–69 days ac
Slide 31: Planned Phase 2 Field Study
Planned Phase 2 Field Study INFECTIOUS DISEASE PORTFOLIO TNX-4800 is intended to be studied in an adaptive randomized, double-blind, placebo-controlled field study • Primary Efficacy Endpoint: Incidence of a first confirmed • Administration: Each 450 mg SC dose or placebo will be case of Lyme diseas
Slide 32: Mosdaprubart (TNX-1500) for the Prevention of Organ Transplant Rejection
Mosdaprubart (TNX-1500)1,2 for the Prevention of Organ Transplant Rejection Phase 1 Topline Results Overview MOA • Pharmacokinetic results showed mean half-life for the • Humanized monoclonal antibody directed against CD40- 10 mg/kg and 30 mg/kg dose groups of 34-38 days, ligand, or CD40L (also know
Slide 33: Mosdaprubart: Expected to Deliver Efficacy Without Compromising Safety
Mosdaprubart: Expected to Deliver Efficacy Without Compromising Safety First Generation • Development halted due to thromboembolic (TE) complications—blood clots—traced to Fc SELECTIVELY MODIFIED anti-CD40L AB gamma receptor (Fc𝛄𝛄R) Ruplizumab full Fab Second Generation Mutated FcγR- • Eliminated…
Slide 34: Other Clinical Programs
Other Clinical Programs © 2026 Tonix Pharmaceuticals Holding Corp. © 2026 Tonix Pharmaceuticals Holding Corp.
Slide 35: TNX-1300 for Cocaine Intoxication
TNX-13001 for Cocaine Intoxication Cocaine Intoxication Overview MOA • With the continued use of cocaine, intense cocaine • CocE is a recombinant protein that degrades cocaine in the cravings occur, resulting in a high potential for abuse bloodstream and addiction, or dependence, as well as the risk
Slide 36: TNX-2900 for Prader Willi Syndrome (PWS)
TNX-29001,2 for Prader Willi Syndrome (PWS) TNX-2900 Overview MOA • Treatment of children and adolescents with PWS • Intranasal potentiated oxytocin (OT) with magnesium • Orphan Drug and Rare Pediatric Disease • Patented potentiated OT formulation is believed to increase designations in the U.S.; el
Slide 37: Tonix is Strategically Executing for the Future
Tonix is Strategically Executing for the Future 2026 Priorities Advance mid-stage clinical Execute on TONMYA launch: Drive sustainable growth to programs: focused on MDD Grow TONMYA patient create value for all and Lyme disease access and sales shareholders prevention Upcoming Expected Milestones 2H
Slide 38: Appendix
Appendix 38 © 2026 Tonix Pharmaceuticals Holding Corp. © 2026 Tonix Pharmaceuticals Holding Corp.
Slide 39: TONMYA Important Safety Information (1 of 2)
TONMYA® (cyclobenzaprine hydrochloride sublingual tablets) INDICATION: TONMYA is indicated for the treatment of fibromyalgia in adults. Important Safety Information (1 of 2) IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS TONMYA is contraindicated: In patients with hypersensitivity to cyclobenzaprine
Slide 40: TONMYA Important Safety Information (2 of 2)
TONMYA (cyclobenzaprine hydrochloride sublingual tablets) INDICATION: TONMYA is indicated for the treatment of fibromyalgia in adults. Important Safety Information (2 of 2) IMPORTANT SAFETY INFORMATION (CONT’D) ADVERSE REACTIONS The most common adverse reactions (incidence ≥2% and at a higher incide
Slide 41: 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 42: 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; cra
Slide 43: 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 44: 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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