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TONIX PHARMACEUTICALS Second Quarter 2026 Financial Results and Operational Highlights AUGUST 10 , 2026 NASDAQ : TNXP PO6158 August 10 , 2026 1675 © 2026 Tonix Pharmaceuticals Holding Corp.
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© 2026 Tonix Pharmaceuticals Holding Corp. 2 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 including those relating to the Company’s expected financial performance, the Company’s anticipated cash runway, the Company’s expected timelines regarding its clinical and pre-clinical programs, expected enrollment in the Company’s clinical trials, expected adoption by the medical community and patients of the Company’s products and expected timelines regarding the Company’s manufacturing processes. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize TONMYA® and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
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© 2026 Tonix Pharmaceuticals Holding Corp. 3 Tonix’s Second Quarter 2026 Earnings Call Demonstrating progress as Tonix focuses on commercial and development pipeline execution • ~$176.2 million in cash and cash equivalents as of June 30, 2026 • Cash runway into early 2Q’ 27 • No debt • ~$11 million in net sales in 2Q’26 (197% QoQ growth) • Growth across our key metrics • ~43% coverage currently across all covered lives after multiple payer agreements signed TONMYA Launch Performance Mid-Stage Clinical Pipeline Progress Financial Position • TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg: Major Depressive Disorder (MDD) − Enrolled first patient in Phase 2 HORIZON study • TNX-4800 (human, anti-OspA monoclonal antibody): Lyme disease prevention − FDA alignment after Type C meeting − Adaptive Phase 2 study expected to start in 1Q’271 − Manufacturing investigational product for 1Q’27 1. Following FDA agreement on final protocol
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© 2026 Tonix Pharmaceuticals Holding Corp. 4 Strong TONMYA Performance in the Second Quarter 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 Key Metrics 2Q Net Sales 197% Growth over Q1’26 ~$11M Prescriptions 12,592 100% 207% 36% Refills New Patients QoQ Growth
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© 2026 Tonix Pharmaceuticals Holding Corp. 5 Advancing Our Strategy Second Quarter and Recent Highlights • 2 commercial coverage agreements with GPOs • Managed Medicare agreement • Medicaid in most states • Robust patient services • Initially targeting 25K HCPs who write ~70% of prescriptions • Sales force expansion to 150 reps by September • Increased breadth and depth of HCP engagements • Move Fibro Forward: disease awareness • DTC and HCP digital tactics • Initiated KOL speaker bureau programs • High-touch KOL engagements • Conference symposia, data publications, and scientific publications • Building fibromyalgia awareness MarketingSalesMarket Access Medical Affairs
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© 2026 Tonix Pharmaceuticals Holding Corp. 6 TNX-102 SL1 to Treat MDD: Targeting Disturbed Sleep Phase 2 potentially pivotal study The Opportunity Adults in the U.S. 21M+ Study Design - Current standard of care causes side effects, including tolerability issues Upcoming Milestone - Patient enrollment at ~30 U.S. sites ongoing • Patients: Targeting ~360 enrolled patients • Enrolling: Adults in the U.S. who are 18+ and currently experiencing a moderate to severe major depressive episode • Primary endpoint: Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6 • Secondary endpoints: Global impression scores, anxiety ratings, and measures of sleep quality and disturbance • Dosing: 5.6 mg taken sublingually at bedtime or matching placebo 1. TNX-102 SL has not been approved for MDD. 2.www.nimh.nih.gov/health/statistics/major-depression.
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© 2026 Tonix Pharmaceuticals Holding Corp. 7 TNX-48001: Differentiated Approach to Lyme Disease Prevention in the U.S Long-acting, human monoclonal antibody targeting OspA of Borrelia burgdorferi, engineered for an extended half-life The Opportunity - No FDA-approved vaccine or prophylactics available - Advantages over vaccines Americans at Risk 87M Planned Study* • Participants: ~3,300 • Targeting: Adults 18+ who live in Lyme- endemic areas in the U.S. who engage in activities that increase their risk of deer tick bites • Primary efficacy endpoint: Lyme disease prevention through 6 months • Key secondary efficacy endpoint: Lyme disease prevention through 3 months • Primary safety objective: Safety and tolerability over a 52-week period after dosing • Dosing: 450 mg SC or in the Spring and ~3 months later (or matching placebo) Upcoming Milestones - Deliver investigational product currently being manufactured to study sites - Start an adaptive Phase 2 field study 1. TNX-4800 has not been approved for any indication. 2. Kugeler KJ, et al. Emerg Infect Dis. 2021;27(2):616-619. *To be reviewed and agreed upon by FDA. Two seasons expected. Could potentially extend to 3rd season depending on attack rate.
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© 2026 Tonix Pharmaceuticals Holding Corp. Financial Highlights CASH & EQUIVALENTS $176.2M As of June 30, 2026, with no debt Full income statement, balance sheet, and cash flow statement are available in the Company’s second quarter 2026 earnings press release. TONMYA NET REVENUE $11.0M Second quarter 2026 ZEMBRACE SYMTOUCH, TOSYMRA NET REVENUE $2.5M Second quarter 2026 TOTAL NET REVENUE $13.5M Second quarter 2026 + =
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© 2026 Tonix Pharmaceuticals Holding Corp. 9 Tonix is Strategically Executing for the Future 2026 Priorities Execute on TONMYA launch Advance mid- stage clinical programs Drive sustainable growth to create value for all shareholders
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© 2026 Tonix Pharmaceuticals Holding Corp. © 2026 Tonix Pharmaceuticals Holding Corp. Thank you 10
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© 2026 Tonix Pharmaceuticals Holding Corp. 11 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 or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs. During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. In patients with hyperthyroidism. WARNINGS AND PRECAUTIONS Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy. Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases. Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures. Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs. CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.
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© 2026 Tonix Pharmaceuticals Holding Corp. 12 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 incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer. DRUG INTERACTIONS MAO inhibitors: Life-threatening interactions may occur. Other serotonergic drugs: Serotonin syndrome has been reported. CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced. Tramadol: Seizure risk may be enhanced. Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked. USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED). Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition. Pediatric use: The safety and effectiveness of TONMYA have not been established. Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions. Please see additional safety information in the full Prescribing Information. To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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© 2026 Tonix Pharmaceuticals Holding Corp. 13 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 that lasts for more than a few minutes or goes away and comes back; severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw; pain or discomfort in your arms, back, neck, jaw or stomach; shortness of breath with or without chest discomfort; breaking out in a cold sweat; nausea or vomiting; feeling lightheaded ZEMBRACE is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem. Do not use ZEMBRACE if you have: • History of heart problems; narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease); uncontrolled high blood pressure; hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider. • Had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation; severe liver problems; taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, dihydroergotamine; are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure. • An allergy to sumatriptan or any of the components of ZEMBRACE. Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements. ZEMBRACE can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
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© 2026 Tonix Pharmaceuticals Holding Corp. 14 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; cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet; increased blood pressure including a sudden severe increase even if you have no history of high blood pressure; medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider. • Serotonin syndrome, a rare but serious problem that can happen in people using ZEMBRACE, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking. • Hives (itchy bumps); swelling of your tongue, mouth, or throat • Seizures even in people who have never had seizures before The most common side effects of ZEMRACE include: pain and redness at injection site; tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired. Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of ZEMBRACE. For more information, ask your provider. This is the most important information to know about ZEMBRACE but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. For full Prescribing Information, visit: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6e5b104f-2b9e-416e-92fb-ef1bdaea867d You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. ZEMBRACE is a prescription medicine used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine. ZEMBRACE is not used to prevent migraines. It is not known if it is safe and effective in children under 18 years of age.
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© 2026 Tonix Pharmaceuticals Holding Corp. 15 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 more than a few minutes or goes away and comes back; severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw; pain or discomfort in your arms, back, neck, jaw, or stomach; shortness of breath with or without chest discomfort; breaking out in a cold sweat; nausea or vomiting; feeling lightheaded TOSYMRA is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam is done and shows no problem. Do not use TOSYMRA if you have: • History of heart problems; narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease); uncontrolled high blood pressure; severe liver problems; hemiplegic or basilar migraines. If you are not sure if you have these, ask your healthcare provider. • Had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation; taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider if you are not sure if your medicine is listed above • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure • An allergy to sumatriptan or any ingredient in TOSYMRA Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements. TOSYMRA can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
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© 2026 Tonix Pharmaceuticals Holding Corp. 16 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; cramping and pain in your legs or hips, feeling of heaviness or tightness in your leg muscles, burning or aching pain in your feet or toes while resting, numbness, tingling, or weakness in your legs, cold feeling or color changes in one or both legs or feet; increased blood pressure including a sudden severe increase even if you have no history of high blood pressure; medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider. • Serotonin syndrome, a rare but serious problem that can happen in people using TOSYMRA, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking. • Seizures even in people who have never had seizures before The most common side effects of TOSYMRA include: tingling, dizziness, feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application site (nasal) reactions, abnormal taste, and throat irritation. Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of TOSYMRA. For more information, ask your provider. This is the most important information to know about TOSYMRA but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for use. For full Prescribing Information, visit: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=015a5cf9-f246-48bc-b91e-cd730a53d8aa. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. TOSYMRA is a prescription medicine used to treat acute migraine headaches with or without aura in adults. TOSYMRA is not used to treat other types of headaches such as hemiplegic or basilar migraines or cluster headaches. TOSYMRA is not used to prevent migraines. It is not known if TOSYMRA is safe and effective in children under 18 years of age. TOSYMRA® Important Safety Information (2 of 2)