Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Corporate Update (August 2025)
29 slides from Tonix Pharmaceuticals's corporate update, Aug 18, 2025
Slide 1: US Approval of Tonmya for the Treatment of Fibromyalgia
US Approval of Tonmya TM for the Treatment of Fibromyalgia August 18, 2025 NASDAQ: TNXP
Slide 2: Agenda + Participants
AGENDA + PARTICIPANTS Introduction, Fibromyalgia Overview & Tonmya TM Label Seth Lederman, M.D. – Chief Executive Officer and Chairman 01 02 03 Commercial and Go - To - Market Strategy Thomas Englese – EVP, Commercial & President, Tonix Medicines Q&A Seth Lederman, M.D. – Chief Executive Officer and
Slide 3: Cautionary Note on Forward-Looking Statements
Cautionary Note on Forward - Looking Statements 3 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 ma
Slide 4: Tonmya
Tonmya (cyclobenzaprine HCl) sbingua ets 28mg spPROVED
Slide 5: Tonmya is the First FDA-Approved Medicine for Fibromyalgia in Over 15 Years
Tonmya TM is the First FDA - Approved Medicine for the Treatment of Fibromyalgia in Over 15 Years 5 1. Bhargava J, Goldin J. Fibromyalgia. [Updated 2025 Jan 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan - . Available from: https://www.ncbi.nlm.nih.gov/books/NB
Slide 6: Tonmya Bypasses First-Pass Liver Metabolism, Leading to Faster Absorption
Sublingual CBP enters the bloodstream directly through the mucosal membrane 6 Tonmya TM is a Tertiary Amine Tricyclic that Bypasses First - Pass Liver Metabolism, Leading to Faster Absorption and Reduced norCyclobenzaprine (“ norCBP ”) tongue Tonmya TM is administered sublingually The sublingual tab
Slide 7: Tonmya First-in-class, First-line Medicine for Fibromyalgia
Tonmya TM First - in - class, First - line Medicine for Fibromyalgia Unique, Sublingual, Proprietary Formulation of Cyclobenzaprine HCl Designed to Optimize Efficacy, Delivery and Absorption 7 Two pivotal studies demonstrated durable reduction in fibromyalgia pain (primary endpoint) Non - opioid ana
Slide 8: Tonmya Prescribing Information Highlights
8 Tonmya TM Prescribing Information Highlights For full prescribing information and safety information, please visit www.Tonmya.com Tonmya (cyclobenzaprine hydrochloride sublingual tablets) TONMYA is indicated for the treatment of fibromyalgia in adults Indications and Usage The recommended dosage o
Slide 9: FDA Approval Based on Studies Demonstrating Durable Improvement in Pain Intensity
9 CI = confidence interval; LS = least squares; SD = standard deviation; SE = standard error 1 LS means, differences and CIs were based on a mixed model for repeated measures with fixed, categorical effects of treatment, c enter, study week, and treatment - by - study week interaction, as well as th
Slide 10: Approval Based on Studies Demonstrating 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 10
Slide 11: Greater Percentage of 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 11 P e r c e n t o f S u b j e c t s 0 10 20 30 40 50 60 70 80 90 100 Percentage Reduction in Pain ≥ 0 ≥ 10% ≥ 20% ≥ 30% ≥ 40% ≥ 50% ≥ 6
Slide 12: Generally Well Tolerated with an Established Safety Profile
12 Generally Well Tolerated with an Established Safety Profile • In Clinical Studies: • The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA TM - treated patients compared to placebo - treated patients) were: oral hypoesthesia, oral discomfort, abnormal product taste,
Slide 13: Tonix is Well Positioned to Support the Commercial Launch
Tonix is Well Positioned to Support the Commercial Launch 13 Tonix Medicines markets two FDA - Approved Rx migraine products and is prepared to launch Tonmya Ended Q2 2025 with ~$125 million in cash and cash equivalents Raised ~$50 million in Q3 2025 through August 11, 2025 via equity sales Strong b
Slide 14: Commercial Strategy
Commercial Strategy Thomas Englese EVP, Commercial and President, Tonix Medicines
Slide 15: an Tonmya’
an Tonmya’ Nees (cyclobenzaprine HC!) sublingual tablets 28mg
Slide 16: Tonix Medicines' Commercial Team Has Extensive Commercial and Launch Expertise
Tonix Medicines’ Commercial Team has Extensive Commercial and Launch Expertise
Slide 17: Fibromyalgia is a Large, Underserved and Dissatisfied Population
17 Fibromyalgia is a Large, Underserved and Dissatisfied Population 2.7 million patients diagnosed and treated annually 5 ~15 million prescriptions are written for the treatment of fibromyalgia (on - and off - label usage) each year 6 Patients have expressed dissatisfaction with currently available
Slide 18: Both Patients and HCPs are Challenged by the Fibromyalgia Journey
Both Patients and HCPs are Challenged by the Fibromyalgia Journey 1 18 1 Market research commissioned by Tonix, January 2025 PATIENTS HCPs FRUSTRATED isolated passed around do less validation unpredictable side effects embarrassed getting worse still tired when I wake up patient variability waning e
Slide 19: Patient and HCP Dissatisfaction Has Led to Significant Off-label Use
Patient and HCP Dissatisfaction has Led to Significant Off - label Use Off - label Opioids are C ommonly P rescribed within 18 Months of Fibromyalgia Diagnosis CBP, cyclobenzaprine; NSAID, nonsteroidal anti - inflammatory drug; SNRI, serotonin norepinephrine reuptake inhibitor; TCA, tricyc lic antid
Slide 20: Disease Awareness Campaign Launched
20 KEY DATA HIGHLIGHTS : • >36,000 unique visitors in first three weeks • Average session durations >5 minutes • ~15% of users either downloaded a Patient Discussion Guide or signed up for more information Disease Awareness Campaign Launched
Slide 21: Our Precision Strategy Will Drive Who and How We Target
Our precision strategy will drive who and how we target WE WILL GO FROM: Traditional specialty - based decile targeting TO: Hyper - focused 1:1 HCP targeting based on ideal patient types ~ 5% of Fibromyalgia - Diagnosing HCPs Write ~70% of Fibromyalgia Prescriptions 1,2 Total Fibromyalgia - Diagnosi
Slide 22: Omnichannel Approach to Empower Reps and Engage Top-prescribing HCPs
Using our Omnichannel Approach to Empower Reps and Engage Top - prescribing HCPs AMPLIFICATION DIRECT SUPPORT Earned Media Corporate Communications Influencer Marketing Owned Social Channels Reputation Management KOL Engagement Search Engine Optimization Digital Media Paid Social Machine Learning Sa
Slide 23: Omnichannel Marketing & Messaging Campaign Planned to Maximize Reach
23 Omnichannel Marketing & Messaging Campaign Planned to Maximize Reach Within the Retail and Specialty Channels HCPs PATIENTS BRANDED ECOSYSTEMS
Slide 24: Payer Education & Engagement; Patient Access & Support Services
24 Payer Education & Engagement Payer Research and Value Analysis Pre - Approval Information Exchange Meetings Burden of Disease & Payer Value Proposition Traditional Pharmacy Savings Program Copay Support for Eligible Patients Digital & Text Enrollment Prior Authorization Support ACCESS PATHWAYS 1
Slide 25: Building a Market Leader
25 Building a Market Leader Q3 2025 • Sales force onboarding • HCP & Patient Omnichannel education and awareness campaign launch Q4 2025 • Commercial and sample availability • Sales representatives in field & tele - sales campaign initiated Q1 2026 • Plan to expand commercial access • Ramp up of edu
Slide 26: Unlocking Transformational Potential in Treating Fibromyalgia
Tonmya TM 26 First FDA - approved medicine for the treatment of fibromyalgia in over 15 years First - in - class medicine ; non - opioid analgesic Demonstrated rapid and durable improvement in chronic widespread pain and was generally well tolerated Large market opportunity with significant unmet ne
Slide 27: Presenters
Seth Lederman, M.D. Chairman and Chief Executive Officer Jessica Morris Chief Operating Officer Gregory Sullivan, M.D. Chief Medical Officer Thomas Englese EVP, Commercial , President, Tonix Medicines
Slide 28: Tonmya Indication and Important Safety Information
TONMYA (cyclobenzaprine hydrochloride sublingual tablets) INDICATION TONMYA is indicated for the treatment of fibromyalgia in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS TONMYA is contraindicated: In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. H
Slide 29: Important Safety Information (Cont'd)
IMPORTANT SAFETY INFORMATION (CONT’D) ADVERSE REACTIONS The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA - treated patients compared to placebo - treate d patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral
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