Tonix Pharmaceuticals Launches TONIX ONE™, a Fully-Integrated Digital Platform Designed to Help Patients Better Understand and Manage Their Migraine Condition

Rhea-AI Summary

Tonix Pharmaceuticals (TNXP) has launched TONIX ONE™, a comprehensive digital platform for migraine management. The platform integrates partnerships with UpScript Telemedicine, ProModRx, Blink Health, and a leading migraine diary app to streamline patient care from symptom tracking to prescription fulfillment.

The platform offers educational resources about migraines, connects patients with specialists via telehealth, and facilitates e-prescription requests. Through the integrated mobile application, patients can track symptoms and gather data-driven insights to optimize their treatment.

Additionally, Tonix provided updates on its development portfolio, including TNX-102 SL for fibromyalgia with a PDUFA date of August 15, 2025, and various other candidates in development such as TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection. The company also highlighted a recent DoD contract worth up to $34 million for developing TNX-4200.

Positive

• Launch of integrated digital platform TONIX ONE expanding service offerings
• TNX-102 SL has Fast Track designation and pending FDA decision
• Secured DoD contract worth up to $34 million over five years
• Strategic partnerships with established healthcare technology companies

Negative

• Multiple drug candidates still in development phase with uncertain outcomes
• Significant competition in migraine treatment market

Insights

Digital Health Strategist

Tonix Pharmaceuticals' launch of the TONIX ONE™ platform represents a strategic pivot toward digital health integration that could significantly enhance the company's position in the competitive migraine treatment market. This fully-integrated platform creates a seamless journey from symptom tracking to prescription fulfillment, addressing critical pain points in patient care.

The platform's strategic partnerships with UpScript Telemedicine, ProModRx, Blink Health, and a leading migraine tracking app create a comprehensive ecosystem that differentiates Tonix's offerings. By connecting their existing FDA-approved treatments - Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) - to this digital infrastructure, Tonix is creating potential for increased prescription volume and improved market penetration.

What makes this platform particularly valuable is its focus on addressing gastroparesis-related limitations of oral medications, effectively steering patients toward Tonix's non-oral delivery systems. This patient education component combined with streamlined access to healthcare providers creates a direct pathway to Tonix's products while providing genuine clinical value.

This initiative demonstrates Tonix's evolution beyond traditional pharmaceutical development into integrated healthcare solutions. By removing barriers between symptom recognition and treatment fulfillment, Tonix has created a potential competitive advantage that could drive increased adoption of their migraine treatments while building valuable patient relationships that extend beyond single prescriptions.

Pharmaceutical Business Analyst

Tonix's launch of TONIX ONE™ represents a strategic commercial infrastructure enhancement that could significantly impact revenue growth for their migraine portfolio. By creating this digital ecosystem, Tonix is effectively building a proprietary patient acquisition channel for their sumatriptan products Zembrace® SymTouch® and Tosymra®.

The platform addresses three critical business challenges: patient education, prescription barriers, and fulfillment friction. By partnering with established players like UpScript for telemedicine and Blink Health for pharmacy services, Tonix has avoided the substantial costs of building these capabilities internally while still capturing the value of the integrated experience.

This platform demonstrates strong commercial acumen by focusing on gastroparesis education - a strategic narrative that highlights limitations of oral migraine medications while positioning Tonix's injectable and nasal delivery systems as superior alternatives. This educational component creates a compelling case for patients to switch from oral treatments to Tonix's delivery methods.

From a competitive standpoint, this platform creates meaningful differentiation in a crowded migraine market dominated by larger players. Rather than competing solely on clinical efficacy, Tonix is now competing on patient experience and accessibility - areas where smaller, more agile companies can potentially outmaneuver pharmaceutical giants. This patient-centric digital strategy could accelerate adoption curves for their migraine products while creating valuable real-world data assets that inform future development and marketing efforts.

Tonix expands its all-in-one platform, partnering with the world’s leading migraine diary app, enhancing disease education and prescription access

CHATHAM, N.J., April 01, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with a portfolio of marketed products and a pipeline of development candidates, today announced the launch of TONIX ONE™, a fully-integrated digital platform designed to help patients better understand and manage their migraine condition. Through a series of strategic partnerships with UpScript Telemedicine, ProModRx, Blink Health and a leading mobile application specializing in disease tracking, reporting and symptom management, Tonix is streamlining the migraine patient journey into a unified digital platform. Please visit www.tonixone.com for details.

“We developed TONIX ONE to leverage innovation and deliver a full-service digital solution that seamlessly guides patients from their migraine diary app to prescription fulfillment within hours. Our goal is not only to educate and empower patients seeking better treatment options but also to remove the barriers to care that many individuals living with migraines face,” said Scott Szymanski, Vice President of Sales and Marketing, Migraine, of Tonix Pharmaceuticals.

TONIX ONE provides an intuitive, comprehensive journey for patients by offering educational resources about migraine and the limitations of oral medications which can sometimes lead to delayed or ineffective symptom relief. The platform also connects patients directly to migraine specialists via telehealth services and e-prescription requests, simplifying and accelerating access to treatment.

“With the launch of TONIX ONE, we are further strengthening Tonix Pharmaceuticals’ position as a leader in innovation, addressing barriers and inefficiencies that stand between patients and the life-changing medications they need,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “By offering a fully-integrated digital platform that streamlines disease state education, prescription acquisition, and fulfillment, we are enhancing access for patients while creating value across our existing portfolio, pipeline, and future business development opportunities.”

Gpmigraine.com provides patients with valuable insights into migraine management by addressing the challenges associated with oral medications due to gastroparesis. The platform helps patients explore alternative treatments and empowers them to make informed decisions about their care.

ProModRx provides patients with a digital solution, dRx Request, to request an e-prescription from their established migraine clinician.

UpScript Health is the leading telemedicine provider in the U.S. For patients who do not have an established migraine clinician or would rather use telemedicine, UpScript provides patients real-time access to 100’s of expert clinicians.

Blink Health is revolutionizing the pharmacy experience, using digital cutting-edge technology to dramatically improve patient access for branded medications.

A leading mobile application operated by a third party, and accessible on the TONIX ONE platform, designed to empower patients suffering from headaches and migraines through data-driven insights, enabling tracking, reporting, and self-management. By providing valuable health data, the platform helps accelerate diagnosis and optimize treatment options, ultimately enhancing the quality of life for people living with migraine symptoms, which in turn can accelerate diagnosis and fine-tune treatment options.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace^® SymTouch^® (sumatriptan injection) 3 mg and Tosymra^® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Please visit www.tonixone.com for Tonix’s fully-integrated digital platform designed to help patients better understand and manage their migraine condition.

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. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. 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 obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; 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 forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. 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.

Media Contact

Lisa DeScenza
LaVoieHealthScience
ldescenza@lavoiehealthscience.com
(978) 395-5970

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Peter Vozzo
ICR Healthcare
peter.vozzo@icrhealthcare.com
(443) 213-0505

Indication and Usage

Zembrace^® SymTouch^® (sumatriptan succinate) injection (Zembrace) and Tosymra^® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

Important Safety Information

Zembrace and Tosymra 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 and Tosymra are 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 or 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
• 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, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
• 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 or Tosymra
  

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace and 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.

Zembrace and 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 Zembrace or 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.
• 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 Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); 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; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).

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 and Tosymra. For more information, ask your provider.

This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

FAQ

What features does Tonix Pharmaceuticals' new TONIX ONE platform offer for migraine patients?

TONIX ONE integrates a migraine diary app, educational resources, telehealth services, and prescription fulfillment capabilities to provide comprehensive migraine management in one digital platform.

When is the PDUFA date for TNXP's TNX-102 SL fibromyalgia treatment?

The FDA has assigned a PDUFA date of August 15, 2025, for the marketing authorization decision on TNX-102 SL for fibromyalgia management.

What is the value of TNXP's new Department of Defense contract?

Tonix secured a contract worth up to $34 million over five years with the DoD's Defense Threat Reduction Agency to develop TNX-4200.

Which key partnerships are included in TNXP's TONIX ONE platform?

TONIX ONE includes partnerships with UpScript Telemedicine, ProModRx, Blink Health, and a leading mobile application for migraine tracking and management.