Tonix Pharmaceuticals Announces Oral Presentation on Mpox and Smallpox vaccine candidate TNX-801 at the Vaccine Congress 2025

Rhea-AI Summary

Tonix Pharmaceuticals (Nasdaq: TNXP) announced that Dr. Sina Bavari will present new data on TNX-801, their mpox and smallpox vaccine candidate, at the Vaccine Congress 2025 in Vienna, Austria. TNX-801 is a minimally replicative, attenuated live virus vaccine that has shown promising preclinical results, demonstrating protection against mpox and other orthopoxviruses after a single dose.

The presentation, scheduled for July 10th at 11:20am GMT+2, will highlight TNX-801's safety, immunogenicity, and efficacy findings. The vaccine has demonstrated durable protection and good tolerability in immunocompromised animals, with no evidence of spreading to blood or tissues even at high doses. TNX-801 also serves as a platform that can deliver multiple protective antigens against diverse viral pathogens.

Additionally, Tonix has a $34 million contract with the U.S. DoD's Defense Threat Reduction Agency for TNX-4200, a broad-spectrum antiviral agent.

Positive

• None.

Negative

• TNX-801 is still in preclinical stage, requiring further clinical trials
• Vaccine efficacy in humans yet to be demonstrated

Single dose vaccination with TNX-801 protects animals from a lethal challenge with monkeypox, the causative agent of mpox

TNX-801 confers durable protection after a single dose

TNX-801 is well tolerated in immunocompromised animals, without evidence of spreading to blood or tissues even at high doses

CHATHAM, N.J., July 07, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Sina Bavari, PhD, Executive Vice President of Infectious Disease Research and Development at Tonix Pharmaceuticals, will present new data on TNX-801 (recombinant horsepox virus, live vaccine) at the upcoming Vaccine Congress 2025.

TNX-801 is a minimally replicative, attenuated live virus vaccine candidate designed to generate durable humoral and cellular immunity after a single dose. Preclinical results in animals have demonstrated protection against mpox and other orthopoxviruses, supporting further clinical evaluation. TNX-801 also serves as an orthopoxvirus vaccine platform that can deliver multiple protective antigens against diverse viral pathogens.

Dr. Bavari will present the safety, immunogenicity, and efficacy findings to date and describe Tonix’s plans to advance the TNX-801 platform into clinical trials to protect against mpox and other viral diseases.

Presentation details

Location: Vienna, Austria
Presentation Date / Time: July 10^th / 11:20am GMT+2
Title: TNX-801, a single-dose live vaccine platform for Mpox and other emerging viral diseases: Safety, Immunogenicity, and Efficacy  
Speaker: Sina Bavari, PhD, Tonix Pharmaceuticals

A copy of the presentation will be posted in the Scientific Presentations section of the Tonix website following the session.

Tonix Pharmaceuticals Holding Corp.^* 
Tonix is a fully-integrated biotech 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 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’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent 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; 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. All other marks are property of their respective owners. 

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

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. 

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

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

Media Contact 
Ray Jordan 
Putnam Insights 
ray@putnaminsights.com

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 is TNX-801 and how does it work against mpox?

TNX-801 is a minimally replicative, attenuated live virus vaccine designed to generate durable humoral and cellular immunity after a single dose. It has shown protection against mpox and other orthopoxviruses in preclinical animal studies.

When will Tonix Pharmaceuticals present the TNX-801 data at Vaccine Congress 2025?

Dr. Sina Bavari will present the TNX-801 data on July 10th at 11:20am GMT+2 in Vienna, Austria.

What are the key findings for TNXP's mpox vaccine candidate?

Key findings include single-dose protection, durable immunity, good tolerability in immunocompromised animals, and no evidence of spreading to blood or tissues even at high doses.

How much funding did Tonix receive from the Department of Defense?

Tonix has a contract with the U.S. DoD's Defense Threat Reduction Agency (DTRA) for up to $34 million over five years for TNX-4200 development.

What is the current development stage of TNXP's TNX-801 vaccine?

TNX-801 is currently in preclinical development, with demonstrated efficacy in animal studies. The company plans to advance the platform into clinical trials for protection against mpox and other viral diseases.