CHATHAM - Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, presented data from a poster presentation at the 66th Annual Scientific Meeting of the American Headache Society (AHS), held June 13-16, 2024.

In the poster presentation titled, 'American Headache Society Consensus Statement and Other Recommendations: How Many Practitioners Comply With the Recommendations,' a retrospective review of real-world data compares real world usage of non-oral migraine products with the most recent AHS consensus statement. The data reaffirms several past recommendations from the AHS and stresses the need for customizing treatment of migraine headaches to the needs of patients, as well as using the most appropriate route of administration for any given acute attack based on the clinical presentation. So far, real world data show that compliance with the guidelines and the consensus statement have yet to be achieved but has the potential to be increased. Specifically, the data show the use of non-oral drugs for treating an acute migraine attack was only 7% in 2012 and has decreased to below 4% in 2023, when the potential need for such drugs is anticipated to be a significant percentage of patients based on epidemiological data.

'We believe personalizing therapy for migraine is the future and it is hoped that non-oral medicines will address some of the persistent dissatisfaction patients experience with their migraine treatments,' said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. 'We hope that educating prescribers about the importance of customized treatments will lead to enhanced satisfaction and improve the quality of life of migraine patients. This represents an opportunity for growth in non-oral first-line therapeutics such Tonix's Zembrace SymTouch and Tosymra.'

'Inconsistent and incomplete response to traditional or emerging oral acute migraine medications continue to be a burden for individuals living with migraines. We believe that both Zembrace SymTouch and Tosymra, due to their rapid-onset and route of administration are well suited to address this unmet need,' said James Hunter, Executive Vice President of Commercial Operations at Tonix Pharmaceuticals and President of Tonix Medicines.

Zembrace SymTouch is the only actively promoted brand of sumatriptan autoinjector in the U.S. (other sumatriptan autoinjector products on the market are Imitrex and generics to Imitrex). It has a unique low dose and has demonstrated onset of migraine pain relief in as few as 10 minutes (17% of patients vs. 5% for placebo)1. Zembrace SymTouch also demonstrated migraine pain freedom for 46% of patients (vs 27% for placebo) at 2 hours in a single-attack, double-blind study (N=230)2. Tosymra employs Intravail permeation enhancer technology and is pharmacokinetically equivalent to 4 mg subcutaneous sumatriptan.3,4, Tosymra delivers migraine pain relief in as little as 10 minutes with just one spray for some patients (13% vs. 5% for placebo).

About Migraine

Nearly 40 million people in the United States suffer from migraine6 and it has been recognized as the second leading cause of disability in the world7. Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity often associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia)8.

Tonix Pharmaceuticals Holding Corp.

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix's development portfolio is focused on central nervous system (CNS) disorders. Tonix's priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix's CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation and is in Phase 2 development supported by a grant from the National institute of Drug Abuse. Tonix's immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a 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 the areas of rare disease and infectious disease. 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.

Tonmya is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has 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.

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, 2023, as filed with the Securities and Exchange Commission (the 'SEC') on April 1, 2024, 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.

Contact:

Jessica Morris

Email: investor.relations@tonixpharma.com

Tel: (862) 904-8182

Peter Vozzo

Email: peter.vozzo@westwicke.com

Tel: (443) 213-0505

(C) 2024 Electronic News Publishing, source ENP Newswire