Cyclobenzaprine hydrochloride

TONMYA (cyclobenzaprine HCl sublingual tablets) for long-term daily dosing at bedtime, is the first new FDA-approved treatment for fibromyalgia in adults in more than 15 years TONMYA commercially launched in the U.S. in November 2025 BERKELEY HEIGHTS, N.J., April 15, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully-integrated, commercial stage biotechnology company, today announced the publication of a paper, "Steady-State Pharmacokinetic Properties of TNX-102 SL, a Sublingual Tablet Formulation of Cyclobenzaprine Hydrochloride (HCl), With Daily Dosing in Healthy Volunteers: A Randomized, Open-Label Trial," in Clinical Pharmacology in Drug Development , the peer-reviewed journal of the American College of Clinical Pharmacology (ACCP). TONMYA ® (cyclobenzaprine HCl sublingual tablets) was investigated under the designation TNX-102 SL. The manuscript can be accessed at . "TONMYA’s sublingual tablet was developed for long-term daily dosing at bedtime to target the nonrestorative sleep associated with fibromyalgia," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Therefore, the steady-state pharmacokinetic (PK) pro Day 20 is more relevant to the product’s indicated dosing regimen than single dose PK. The dynamic changes in cyclobenzaprine concentrations from sublingual tablet dosing over 24 hours at Day 20 are believed to provide pharmacodynamic effects on the brain owing to rapid absorption and distribution. The sublingual tablet was designed with a basifying ingredient and cyclobenzaprine–mannitol eutectic to provide transmucosal absorption to speed uptake, deliver maximum plasma levels of cyclobenzaprine during the middle of the sleep phase, and bypass first-pass liver metabolism. This study supported TONMYA's approval for the treatment of fibromyalgia in adults by the U.S. Food and Drug Administration (FDA) and elucidates how TONMYA’s pharmacokinetic pro consistent with long-term daily dosing at bedtime.” Dr. Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals added, “The dynamic changes in cyclobenzaprine concentrations are magnified by the higher predicted percentage of receptors by cyclobenzaprine relative to norcyclobenzaprine occupied (i.e., 5-HT 2A , α1-adrenergic, H 1 , and M 1 ) during sleep hours after bedtime dosing. For example, 5-HT 2A antagonism increases slow wave sleep (SWS) activity during non–rapid eye movement (NREM) sleep, and α1-adrenergic antagonism increases the time and continuity in REM sleep and reduces noradrenergic sympathetic tone, which has the potential to impair the quality of SWS.” The publication reports findings from a single-center, randomized, open-label, multiple-dose, parallel-group pharmacokinetic study conducted in 60 healthy adult volunteers. Participants were randomized 1:1 to receive either sublingual cyclobenzaprine HCl 5.6 mg (two 2.8 mg tablets, the FDA approved dose of TONMYA for adults) or oral cyclobenzaprine HCl extended-release (ER) 30 mg capsules (AMRIX ® ) once daily for 20 consecutive days. At steady state, exposure to both plasma cyclobenzaprine and norcyclobenzaprine for sublingual tablets (TNX-102 SL) 5.6 mg was substantially lower than that to the comparator listed drug, oral cyclobenzaprine HCl ER 30 mg capsules. Importantly, when exposures were normalized by dose, cyclobenzaprine bioavailability is higher for sublingual tablets at 5.6 mg relative to oral ER 30 mg capsules. Both treatments had comparable metabolic profiles of Phase I and II metabolites in human plasma. These pharmacokinetic results are consistent with the use of sublingual cyclobenzaprine HCl tablets at 5.6 mg to target nonrestorative sleep in fibromyalgia, reduce pain, and potentially improve other symptoms of the condition. On Day 1, sublingual cyclobenzaprine was detectable within one hour of administration, with median time to peak plasma concentration (t max ) approximately three hours earlier than the oral ER capsule formulation (five vs. eight hours). At steady state on Day 20, the sublingual t max remained two hours earlier (five vs. seven hours). The sublingual formulation demonstrated markedly higher cyclobenzaprine bioavailability when exposures were normalized by dose. Daily morning administration of sublingual cyclobenzaprine HCl 5.6 mg over 20 days was generally safe and well tolerated. There were no serious adverse events or treatment discontinuations due to adverse events. All treatment-emergent adverse events were mild or moderate in severity. The most commonly reported adverse events with sublingual tablets occurring at rates higher than oral ER capsules were oral hypoesthesia, abnormal product taste, somnolence, back pain, and fatigue. Since TONMYA is intended for bedtime administration, the effects of somnolence are expected to be an attribute for bedtime dosing when sleepiness effects are beneficial. No metabolites unique to the sublingual route of administration were identified. About Fibromyalgia Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6-12 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. About TONMYA ® (cyclobenzaprine HCl sublingual tablets) TONMYA (cyclobenzaprine HCl sublingual tablets) is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which, compared to the immediate-release oral cyclobenzaprine, provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. The reduction in norcyclobenzaprine, a potent inhibitor of the norepinephrine transporter (NET), is thought to be key to the durability of treatment response as NET inhibition is activating and disruptive to slow wave sleep. As a multifunctional agent with potent binding and antagonist activities at the 5-HT 2A serotonergic, α 1 -adrenergic, H 1 -histaminergic, and M 1 -muscarinic receptors, TONMYA was approved on August 15, 2025, by the FDA for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. TNX-102 SL is also being developed to treat acute stress reaction (ASR)/acute stress disorder (ASD), and major depressive disorder (MDD). The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TONMYA composition. These patents are expected to provide TONMYA with U.S. market exclusivity until 2034/2035. Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals* is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA ® (cyclobenzaprine HCl sublingual tablets 2.8 mg), is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace ® Symtouch ® (sumatriptan injection 3 mg) and Tosymra ® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA ® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti- Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. In addition, the Company is progressing TNX-2900 (intranasal potentiated oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. To learn more, visit and follow the Company on LinkedIn and X . *Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners. Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. 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. Investor Contacts Jessica Morris Tonix Pharmaceuticals (862) 799-8599 investor.relations@tonixpharma.com Brian Korb astr partners (917) 653-5122 brian.korb@astrpartners.com Media Contacts Deborah Elson Tonix Pharmaceuticals deborah.elson@tonixpharma.com Ray Jordan Putnam Insights ray@putnaminsights.com INDICATION TONMYA is indicated for the treatment of fibromyalgia in adults. 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. 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 .

TNX-4800 is a long-acting anti-Borrelia burgdorferi OspA human monoclonal antibody in development as a single-dose Lyme prophylactic Phase 1 study of TNX-4800 demonstrated safety, tolerability, and pharmacokinetics supportive of approximately four months protection Company expects to initiate a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study in the first half of 2027, pending FDA clearance BERKELEY HEIGHTS, N.J., March 31, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced Phase 1 data of TNX-4800 (formerly known as mAb 2217LS) 1,2 was presented by Mark S. Klempner, MD, professor of medicine at UMass Chan Medical School, an inventor of TNX-4800 and principal investigator of the study, on March 30, 2026, at the World Vaccine Congress Washington 2026. Tonix also announced its planned strategy for an adaptive Phase 2 field study expected to initiate in the first half of 2027, pending FDA clearance. TNX-4800 is a long-acting borreliacidal (or bactericidal), human monoclonal antibody (mAb) with an engineered crystallizable fragment (Fc) domain for an extended half-life that targets the outer surface protein A (OspA) of Borrelia burgdorferi , which causes 99.9% of Lyme disease cases in the U.S. 3,4 Tonix is developing TNX-4800, which the Company in-licensed from UMass Chan Medical School in 2025, as a prophylactic that is administered in a single subcutaneous (SC) dose expected to provide approximately four months protection to people in endemic areas during the U.S. tick season. There are currently no marketed U.S. Food and Drug Administration (FDA)-approved vaccines or prophylactics to protect against Lyme disease. “TNX-4800 is expected to provide a preventative option to the 87 million 5 people in the United States who are at high risk of contracting the disease because they live, work, or vacation in a tick-endemic area,” said Seth Lederman, MD, Chief Executive Officer of Tonix Pharmaceuticals. “As a monoclonal antibody, we believe TNX-4800 offers significant advantages over vaccines in development. Lyme disease vaccines that elicit antibodies to OspA currently in development take more than six months to offer protection and require complex immunization schedules. A previously approved anti-OspA vaccine was withdrawn due to poor uptake, 6 potentially relating to its complex immunization schedule.” Dr. Lederman continued, “TNX-4800, targeting Borrelia burgdorferi , the serotype that causes 99.9% of Lyme disease in the U.S., is a single dose subcutaneous administration that potentially offers immunity within two days for a duration of approximately four months. We believe TNX-4800’s differentiating characteristics could offer meaningful improvements for people seeking protection from Lyme disease. We believe the Phase 1 pharmacokinetic (PK) data support our plan to conduct an adaptive field study in the first half of 2027, pending FDA clearance, in which protection at four months is the primary endpoint, and protection at six months is a key secondary endpoint.” Phase 1 Results “Our study demonstrated potentially protective blood levels of TNX-4800 at two days, with protective blood levels sustained for at least four months due to its extended half-life design,” said Dr. Klempner. “Additionally, with its differentiated mechanism of action, TNX-4800 has the potential to provide passive immunity by directly supplying neutralizing antibodies, bypassing the need for a vaccine to induce a patient’s immune system to generate its own antibodies, which can be associated with other issues. We look forward to further clinical investigation of TNX-4800 as we strive to overcome this major public health challenge.” The primary objective of the Phase 1 study was to evaluate the safety and tolerability of a SC injection of TNX-4800 when administered to healthy male and female subjects ages 19-65 years old. The secondary objective was to evaluate the PK of a SC dose of TNX-4800 when administered to healthy subjects. 44 subjects were enrolled, with 41 subjects completing the study. Subjects received a single SC administration of placebo or TNX-4800 at 0.5, 1.5, 5, or 10 mg/kg. Results showed no significant clinical or laboratory safety signals, with most adverse events mild or moderate. Peak serum concentration (Cmax) increased by ~25-fold for a 20-times increase in dose. Serum TNX-4800 was measurable at earliest sampling time of two days, indicating rapid systemic absorption. TNX-4800 levels remained quantifiable for >200 days in 80% of subjects at the lowest dose, and for up to 350 days in the majority of subjects at higher doses (i.e., ≥ 1.5 mg/kg). The mean half-life ranged from 62-69 days across TNX-4800 cohorts. Serum concentrations were quantifiable for up to 12 months in most subjects. Mean exposure for the 10 mg/kg cohort had 200 days in 80% of volunteers at the lowest dose and for up to 350 days in the majority of volunteers at higher doses (i.e., ≥ 1.5 mg/kg). Mean half-life ranged from 62-69 days across groups. Serum concentrations remained quantifiable for up to 12 months in most subjects. Mean exposure for the 10 mg/kg cohort was less than 17% of the highest exposures in a rat toxicology study. Anti-drug antibodies were detected in <10% of treated subjects, with no impact on PK. Most adverse events were mild or moderate. TNX-4800 was determined to be generally safe and well tolerated. About Lyme Disease In the United States, Lyme disease is caused by the bacterium Borrelia burgdorferi . Lyme disease remains the most common vector-borne infection in the United States, and its incidence is climbing each year, due in part to global changes in climate expanding the habitat range for ticks. 9 It occurs most commonly in the Northeast, mid-Atlantic, and upper-Midwest regions. Lyme disease bacteria are transmitted through the bite of infected Ixodes ticks. Typical symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. If left untreated, infection can spread to joints, heart, and nervous system. Laboratory testing is helpful if used correctly and performed with FDA-cleared tests. Although many cases of Lyme disease can be treated successfully with antibiotics, diagnosis and treatment are often delayed or missed. Chronic Lyme is considered an Infection Associated Chronic Illness (IACI), and is a chronic, debilitating disease state characterized by joint and muscle pain, fatigue, and other symptoms. 10 Citations 1 Schiller ZA, et al. J Clin Invest. 2021 131(11):e144843. 2 Wang Y, et al. J Infect Dis . 2016. 214(2):205-11. 3 Marques AR, et al. Emerg Infect Dis. 2021. 27(8):2017-2024. 4 Pritt BS, et al. Lancet Infect Dis. 2016. 6(5):556-564. 5 Kugeler KJ, et al. Emerg Infect Dis. 2021. 27(2):616-619. 6 Nigrovic LE, et al. Epidemiol Infect. 2006. Aug 8;135(1):1-8. 7 Comstedt P, et al. Vaccine . 2015 33(44):5982-8. 8 Connaught’s (ImuLyme™) and SmithKline Beecham’s (LYMErix™) Lyme disease vaccines were withdrawn. Nigrovic LE, et al. Epidemiol Infect. 2007 135(1):1-8. 9 Gomes-Solecki M, et. al. Clin Infect Dis. 2020 70(8):1768-1773. 10 National Academies of Sciences, Engineering, and Medicine. 2025. Charting a Path Toward New Treatments for Lyme Infection-Associated Chronic Illnesses . Washington, DC: The National Academies Press. Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals* is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA ® (cyclobenzaprine HCl sublingual tablets 2.8 mg), is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace ® SymTouch ® (sumatriptan injection 3 mg) and Tosymra ® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA ® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. In addition, the Company’s CNS portfolio includes TNX-2900 (intranasal oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti- Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. To learn more, visit and follow the Company on LinkedIn and X . *Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners. About UMass Chan Medical School UMass Chan Medical School, one of five campuses of the University of Massachusetts system, comprises the T.H. Chan School of Medicine, the Morningside Graduate School of Biomedical Sciences, the Tan Chingfen Graduate School of Nursing, ForHealth Consulting at UMass Chan Medical School, MassBiologics, and a thriving Nobel-Prize-winning biomedical research enterprise. UMass Chan is advancing together to improve the health and wellness of our diverse communities throughout Massachusetts and across the world by leading and innovating in education, research, health care delivery and public service. It is ranked among the best medical schools in the nation for primary care education and biomedical research by U.S. News & World Report. Learn more at . Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. 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. Investor Contacts Jessica Morris Tonix Pharmaceuticals investor.relations@tonixpharma.com (862) 799-8599 Brian Korb astr partners (917) 653-5122 brian.korb@astrpartners.com Media Contacts Deborah Elson Tonix Pharmaceuticals deborah.elson@tonixpharmaceuticals.com Ray Jordan Putnam Insights ray@putnaminsights.com