Tonix Pharmaceuticals Promotes Thomas Englese, MBA, to Chief Commercial Officer

Tonix expands its executive team by naming its first Chief Commercial Officer to oversee TONMYA and migraine product commercialization.

Rhea-AI Summary

Tonix Pharmaceuticals (TNXP) has promoted Thomas Englese, MBA, to Chief Commercial Officer, effective immediately, elevating him from Executive Vice President, Commercial Operations, a role he has held since September 2024.

He will continue to lead sales, marketing, market access and commercial operations for TONMYA (cyclobenzaprine HCl sublingual tablets) for fibromyalgia in adults, and the acute migraine brands Zembrace SymTouch and Tosymra. The company credits his leadership with shaping its commercial organization and the U.S. launch and early growth of TONMYA across sales, managed care and patient access. Tonix describes TONMYA as the first treatment for fibromyalgia in more than 15 years and is extending its underlying science in Phase 2 studies for major depressive disorder and acute stress disorder/acute stress reaction, while also advancing Phase 2‑ready programs in infectious disease and immunology.

Key Terms

serotonin syndrome, mao inhibitors, auc, phase 2, +1 more

5 terms

serotonin syndrome medical

"increases the risk of serotonin syndrome, a potentially life-threatening condition"

A potentially serious medical condition caused by excess serotonin activity in the nervous system, usually from certain medications or drug interactions; symptoms range from mild agitation, tremor and rapid heart rate to severe high fever, muscle rigidity, seizures or loss of consciousness. It matters to investors because occurrences, clinical-trial signals, or regulatory findings about serotonin syndrome can affect a drug’s safety profile, labeling, approval prospects and commercial marketability—similar to a product recall or defect report for a consumer good.

mao inhibitors medical

"With concomitant use of monoamine oxidase (MAO) inhibitors"

Monoamine oxidase inhibitors (MAO inhibitors) are a class of prescription medicines that block the enzyme monoamine oxidase, which breaks down neurotransmitters such as serotonin, dopamine and norepinephrine. They are important to investors because their unique mechanism, safety profile and dietary or drug interaction risks affect regulatory review, labeling, market size and competitive positioning for companies developing or selling treatments for depression, Parkinson’s disease and other neurological or psychiatric conditions; think of them as a powerful tool that requires careful handling.

auc medical

"Cyclobenzaprine exposure (AUC) was increased in patients"

Area under the curve (AUC) measures the total exposure of the body to a drug over time by calculating the area beneath a plot of drug concentration versus time. For investors, AUC indicates how much of a medicine reaches and stays in the bloodstream, which affects dosing, safety and effectiveness—similar to measuring how much water flows through a pipe over a day rather than just its peak pressure.

phase 2 medical

"Tonix is extending the science behind TONMYA in Phase 2 clinical studies"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

contraindicated medical

"TONMYA is contraindicated: In patients with hypersensitivity"

An instruction that a drug, treatment, device, or procedure should not be used in a particular situation because it could harm the patient or make the therapy ineffective. For investors, contraindications matter because they narrow who can safely use a product, affect labeling and regulatory approval, limit market size, and raise potential liability — like a clear “do not use” warning that reduces the pool of customers and revenue potential.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Mr. Englese’s leadership of Tonix’s commercial organization since 2024 has included the go-to-market strategy and U.S. launch of TONMYA®, with growth across sales, managed care, and patient access

BERKELEY HEIGHTS, N.J., Sept. 08, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial-stage biopharmaceutical company, today announced the promotion of Thomas Englese to Chief Commercial Officer, effective immediately. Mr. Englese has served as Tonix’s Executive Vice President, Commercial Operations, since September 2024. He will continue to direct sales, marketing, market access, and commercial operations for TONMYA (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults, and Zembrace^® SymTouch^® (sumatriptan injection) and Tosymra^® (sumatriptan nasal spray) for the treatment of acute migraine in adults.

"Tom has been instrumental to the formation of Tonix’s commercial organization and launch of TONMYA, a first-in-class, non-opioid analgesic for the treatment of fibromyalgia,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “Tom’s vision and leadership have shaped a high-performing, patient-centric team at Tonix. Promoting Tom to serve as our first Chief Commercial Officer is an important milestone for the Company. We believe we are well positioned to bring TONMYA as a treatment option to more fibromyalgia patients and create stakeholder value.”

Thomas Englese, MBA, Chief Commercial Officer of Tonix Pharmaceuticals, added, "I am honored to be promoted to Chief Commercial Officer of Tonix as we expand the launch of TONMYA more broadly to new healthcare providers and more deeply to current prescribers. I believe our exceptional team has the potential to achieve Tonix’s mission of making a difference for patients with fibromyalgia and migraine patients. We have had an encouraging start to our launch as patients are introduced to and prescribed TONMYA. I am proud of our team’s progress with our access wins and increased awareness of TONMYA and fibromyalgia, and encouraging trends across our launch key performance indicators. Our launch priorities remain clear, and we will continue to focus on expanding access, growing patients and prescribers, and increasing sales.”

Mr. Englese brings extensive industry experience building and scaling large global commercial organizations, overseeing strategy and P&Ls for multi-million- and billion-dollar products across therapeutic areas, launching products, and supporting cross-organizational business functions. Prior to Tonix, Mr. Englese served as Chief Commercial Officer of Tris Pharmaceuticals, where he was responsible for the ADHD global brand business, and Aziyo, where he was responsible for the cardiac and soft tissue business and serving on the initial public offering (IPO) leadership team. At Mallinckrodt plc, formerly Ikaria Inc., Mr. Englese served as Senior Vice President and General Manager of North America Hospital Therapies, Vice President and General Manager of Global Critical Care, and Vice President of Customer Operations, responsible for the North America franchise. Earlier in his career, he was Senior Director of Business Operations, Global Analytics, and a Finance Manager at Baxter Healthcare International, and he held positions at Pfizer and Wells Fargo. Mr. Englese received an MBA in finance from Pennsylvania State University and a B.S. in marketing from Villanova University.

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals* is a fully integrated, commercial-stage biopharmaceutical company focused on central nervous system (CNS) disorders, infectious diseases, and immunology conditions with high unmet medical needs. TONMYA^® (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s flagship internally conceived and developed medicine, is the first treatment for fibromyalgia 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 extending the science behind TONMYA in Phase 2 clinical studies to evaluate the potential of TNX-102 SL in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including Phase 2-ready monoclonal antibody TNX-4800 (anti-OspA mAb) for Lyme disease prevention in the U.S. and TNX-801 (horsepox, live virus vaccine), a vaccine in development for the prevention of mpox and smallpox. Within immunology, TNX-1500 (anti-CD40L mAb) is a Phase 2-ready, third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. To learn more, visit www.tonixpharma.com.

*Tonix’s product development candidates, including TNX-102 SL for new, unapproved indications, 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. 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

Deborah Elson
Tonix Pharmaceuticals
deborah.elson@tonixpharma.com
investor.relations@tonixpharma.com

Brian Korb
astr partners
(917) 653-5122
brian.korb@astrpartners.com

Media Contacts

Andrea Cohen
Sam Brown Inc.
(917) 209-7163
andreacohen@sambrown.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 www.fda.gov/medwatch.

FAQ

What responsibilities will Thomas Englese have as Chief Commercial Officer at Tonix?

As Chief Commercial Officer, Thomas Englese will continue to direct sales, marketing, market access and commercial operations for TONMYA for fibromyalgia in adults, as well as for Zembrace SymTouch and Tosymra for the treatment of acute migraine in adults.

What is TONMYA and for what condition is it indicated?

TONMYA is cyclobenzaprine HCl sublingual tablets 2.8 mg, described as a first-in-class, non-opioid analgesic and the company’s flagship internally developed medicine. It is indicated for the treatment of fibromyalgia in adults.

What are the main contraindications for using TONMYA?

TONMYA is contraindicated in patients with hypersensitivity to cyclobenzaprine or any inactive ingredient; with concomitant use of MAO inhibitors or within 14 days of their discontinuation; during the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure; and in patients with hyperthyroidism.

What key warnings and precautions are highlighted for TONMYA?

Warnings and precautions include risk of embryofetal toxicity and neural tube defects when used two weeks prior to conception and during the first trimester; risk of serotonin syndrome when combined with other serotonergic drugs; tricyclic antidepressant-like adverse reactions such as arrhythmias and CNS effects; atropine-like effects in susceptible patients; CNS depression affecting the ability to drive or operate machinery, especially with other CNS depressants; and increased oral mucosal adverse reactions compared with placebo.

Which other clinical programs and therapeutic areas is Tonix pursuing?

Tonix is extending the science behind TONMYA in Phase 2 clinical studies of TNX-102 SL for major depressive disorder and acute stress disorder/acute stress reaction. In infectious diseases, it is advancing Phase 2‑ready monoclonal antibody TNX-4800 for Lyme disease prevention and vaccine TNX-801 for mpox and smallpox prevention. In immunology, TNX-1500 is a Phase 2‑ready CD40 ligand inhibitor being developed for the prevention of kidney transplant rejection.

What are the most common adverse reactions reported with TONMYA?

The most common adverse reactions (incidence ≥2% and higher than placebo) are oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

Are there any special dosage or use considerations for TONMYA in patients with hepatic impairment?

For patients with mild hepatic impairment (Child Pugh A), the recommended TONMYA dosage is 2.8 mg once daily at bedtime, which is lower than in patients with normal hepatic function. Use of TONMYA is not recommended in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment, because cyclobenzaprine exposure (AUC) is increased, which may raise the risk of adverse reactions.