Tonix Pharmaceuticals Holding Corp. presented new data from the Phase 3 RESILIENT trial of Tonmya (TNX-102 SL, cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia in an oral presentation at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting on May 29, 2024 in Miami Beach, Fla. In the oral presentation titled, " effects of Bedtime TNX-102 SL (Sublingual Cyclobenzaprine HCl) on Mood and anxiety Symptoms in Fibromyalgia: Results of the Phase 3 RESILIENT Trial," Seth Lederman, MD, Chief Executive Officer, presented new data suggesting activity for improvement in depressive symptoms with Tonmya.

Depression was frequent among patients enrolled in the RESILIENT trial: 47% reported experiencing depression within the past 6 months upon fibromyalgia diagnosis and ~25% of the intent-to-treat (ITT) population had experienced a lifetime major depressive episode (MDE). The effect of Tonmya on depressive symptoms was studied using the Beck Depression Inventory-II (BDI-II). Tonmya also demonstrated statistically significant and clinically meaningful results in all six pre-specified key secondary endpoints including those related to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function." In the RESILIENT trial, there were no new safety signals, low rates of systemic adverse events, and a favorable tolerability profile.

Tonix remains on track to submit an NDA to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya for the management of fibromy fibromyalgia and has scheduled a Type B pre-NDA meeting with FDA for the second quarter of 2024. 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 fib fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix Medicines, commercial subsidiary, markets Zembrace®?

SymTouch®? (sumatriptan injection) 3 mg and Tosymra®? (sumatript an 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.1 Tonmya?? is conditionally accepted by the U.S. Food & Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromy Fibromyalgia. Tonmya has not been approved for any indications.

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 products; risks related to the failure of clinical development of product candidates; need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party parties.